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               GLOBAL STRATEGY FOR
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        ASTHMA MANAGEMENT AND PREVENTION
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                       UPDATED 2009
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              Global Strategy for Asthma Management and Prevention
              The GINA reports are available on www.ginasthma.org.
Global Strategy for Asthma Management and Prevention 2009 (update)


    GINA ExEcutIvE commIttEE*                                                            GINA ScIENcE commIttEE*




                                                                                                                                        E
    Eric D. Bateman, MD, Chair                                                           Mark FitzGerald, MD, Chair




                                                                                                                                       C
    University Cape Town Lung Institute                                                  University of British Columbia




                                                                                                                                      U
    Cape Town, South Africa                                                              Vancouver, BC, Canada




                                                                                                                                   D
    Louis-Philippe Boulet, MD                                                            Neil Barnes, MD
    Hôpital Laval                                                                        London Chest Hospital




                                                                                                                                  O
    Sainte-Foy , Quebec, Canada                                                          London, England, UK




                                                                                                                                  R
    Alvaro A. Cruz, MD                                                                   Peter J. Barnes, MD




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    Federal University of Bahia                                                          National Heart and Lung Institute
    School of Medicine                                                                   London, England, UK
    Salvador, Brazil




                                                                                                                             R
                                                                                         Eric D. Bateman, MD
    Mark FitzGerald, MD                                                                  University Cape Town Lung Institute




                                                                                                                    R
    University of British Columbia                                                       Cape Town, South Africa
    Vancouver, BC, Canada




                                                                                                                   O
                                                                                         Allan Becker, MD
    Tari Haahtela, MD                                                                    University of Manitoba




                                                                                                           R
    Helsinki University Central Hospital                                                 Winnipeg, Manitoba, Canada
    Helsinki, Finland




                                                                                                        TE
                                                                                         Jeffrey M. Drazen, MD
    Mark L. Levy, MD                                                                     Harvard Medical School




                                                                                                 AL
    University of Edinburgh                                                              Boston, Massachusetts, USA
    London England, UK
                                                                                         Robert F. Lemanske, Jr., M.D.
    Paul O'Byrne, MD                                                                     University of Wisconsin
                                                                                          T
    McMaster University                                                                  School of Medicine
                                                                                         O
    Ontario, Canada                                                                      Madison, Wisconsin, USA
                                                                                    N

    Ken Ohta, MD, PhD                                                                    Paul O'Byrne, MD
    Teikyo University School of Medicine                                                 McMaster University
                                                                       O


    Tokyo, Japan                                                                         Ontario, Canada
                                                                     -D




    Pierluigi Paggiaro, MD                                                               Ken Ohta, MD, PhD
    University of Pisa                                                                   Teikyo University School of Medicine
    Pisa, Italy                                                                          Tokyo, Japan
                                                         L
                                                       IA




    Soren Erik Pedersen, M.D.                                                            Soren Erik Pedersen, M.D.
    Kolding Hospital                                                                     Kolding Hospital
                                                      R




    Kolding, Denmark                                                                     Kolding, Denmark
                                             E




    Manuel Soto-Quiroz, MD                                                               Emilio Pizzichini, MD
    Hospital Nacional de Niños                                                           Universidade Federal de Santa Catarina
                                          AT




    San José, Costa Rica                                                                 Florianópolis, SC, Brazil
                                     M




    Gary W. Wong, MD                                                                     Helen K. Reddel, MD
    Chinese University of Hong Kong                                                      Woolcock Institute of Medical Research
    Hong Kong ROC                                                                        Camperdown, NSW, Australia
                          D
                        TE




                                                                                         Sean D. Sullivan, PhD
                                                                                         Professor of Pharmacy, Public Health
                                                                                         University of Washington
                   H




                                                                                         Seattle, Washington, USA
             IG




                                                                                         Sally E. Wenzel, M.D.
                                                                                         University of Pittsburgh
        R




                                                                                         Pittsburgh, Pennsylvania, USA
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                                                                                         Heather J. Zar, MD
                                                                                         University of Cape Town
                                                                                         Cape Town, South Africa
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    *Disclosures for members of GINA Executive and Science Committees can be found at:                                                 i
    http://www.ginasthma.com/Committees.asp?l1=7&l2=2
PREFACE
    Asthma is a serious global health problem. People of all       In spite of these dissemination efforts, international




                                                                                                                        E
    ages in countries throughout the world are affected by this    surveys provide direct evidence for suboptimal asthma




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    chronic airway disorder that, when uncontrolled, can place     control in many countries, despite the availability of
    severe limits on daily life and is sometimes fatal. The        effective therapies. It is clear that if recommendations




                                                                                                                      U
    prevalence of asthma is increasing in most countries,          contained within this report are to improve care of people




                                                                                                                D
    especially among children. Asthma is a significant burden,     with asthma, every effort must be made to encourage




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    not only in terms of health care costs but also of lost        health care leaders to assure availability of and access to




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    productivity and reduced participation in family life.         medications, and develop means to implement effective




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                                                                   asthma management programs including the use of
    During the past two decades, we have witnessed many            appropriate tools to measure success.
    scientific advances that have improved our understanding




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    of asthma and our ability to manage and control it             In 2002, the GINA Report stated that “it is reasonable to
    effectively. However, the diversity of national health care




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                                                                   expect that in most patients with asthma, control of the
    service systems and variations in the availability of asthma   disease can, and should be achieved and maintained.”




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    therapies require that recommendations for asthma care         To meet this challenge, in 2005, Executive Committee
    be adapted to local conditions throughout the global




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                                                                   recommended preparation of a new report not only to
    community. In addition, public health officials require        incorporate updated scientific information but to implement




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    information about the costs of asthma care, how to             an approach to asthma management based on asthma
    effectively manage this chronic disorder, and education        control, rather than asthma severity. Recommendations to



                                                                         AL
    methods to develop asthma care services and programs           assess, treat and maintain asthma control are provided in
    responsive to the particular needs and circumstances           this document. The methods used to prepare this
    within their countries.                                         T
                                                                   document are described in the Introduction.
                                                                   O
    In 1993, the National Heart, Lung, and Blood Institute         It is a privilege for me to acknowledge the work of the
                                                                   N

    collaborated with the World Health Organization to             many people who participated in this update project, as
    convene a workshop that led to a Workshop Report:
                                                        O


                                                                   well as to acknowledge the superlative work of all who
    Global Strategy for Asthma Management and Prevention.          have contributed to the success of the GINA program.
                                                      -D




    This presented a comprehensive plan to manage asthma
    with the goal of reducing chronic disability and premature     The GINA program has been conducted through
    deaths while allowing patients with asthma to lead
                                             L




                                                                   unrestricted educational grants from AstraZeneca,
    productive and fulfilling lives.
                                           IA




                                                                   Boehringer Ingelheim, Chiesi Group, Cipla,
                                                                   GlaxoSmithKline, Meda Pharma, Merck Sharp & Dohme,
                                          R




    At the same time, the Global Initiative for Asthma (GINA)
                                                                   Mitsubishi Tanabe Pharma, Novartis, Nycomed and
    was implemented to develop a network of individuals,
                                    E




                                                                   PharmAxis. The generous contributions of these
    organizations, and public health officials to disseminate
                                 AT




                                                                   companies assured that Committee members could meet
    information about the care of patients with asthma while at
                                                                   together to discuss issues and reach consensus in a
    the same time assuring a mechanism to incorporate the
                              M




                                                                   constructive and timely manner. The members of the
    results of scientific investigations into asthma care.
    Publications based on the GINA Report were prepared            GINA Committees are, however, solely responsible for the
                     D




    and have been translated into languages to promote             statements and conclusions presented in this publication.
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    international collaboration and dissemination of
    information. To disseminate information about asthma           GINA publications are available through the Internet
                H




    care, a GINA Assembly was initiated, comprised of asthma       (http://www.ginasthma.org).
           IG




    care experts from many countries to conduct workshops
    with local doctors and national opinion leaders and to hold
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    seminars at national and international meetings. In
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    addition, GINA initiated an annual World Asthma Day (in
    2001) which has gained increasing attention each year to
                                                                   Eric Bateman, MD
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    raise awareness about the burden of asthma, and to
    initiate activities at the local/national level to educate     Chair, GINA Executive Committee
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    families and health care professionals about effective         University of CapeTown Lung Institute
    methods to manage and control asthma.                          Cape Town, South Africa

    ii
GLOBAL STRATEGY FOR ASTHMA MANAGEMENT AND PREVENTION
                             Table of Contents
    PREFACE .........................................................................ii    CLINICAL DIAGNOSIS...................................................16




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                                                                                             Medical History...........................................................16




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    METHODOLOGY AND SUMMARY OF NEW                                                             Symptoms ..............................................................16




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     RECOMMENDATION, 2007 UPDATE .........................vi                                   Cough variant asthma ............................................16




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                                                                                               Exercise-Induced bronchospasm ...........................17
    INTRODUCTION ..............................................................x             Physical Examination .................................................17




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                                                                                             Tests for Diagnosis and Monitoring ............................17




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    CHAPTER 1. DEFINITION AND OVERVIEW..................1                                      Measurements of lung function...............................17




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                                                                                               Spirometry ..............................................................18
    KEY POINTS ....................................................................2           Peak expiratory flow ...............................................18




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                                                                                               Measurement of airway responsiveness.................19
    DEFINITION .....................................................................2          Non-Invasive markers of airway inflammation ........19




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                                                                                               Measurements of allergic status .............................19




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    THE BURDEN OF ASTHMA.............................................3
      Prevalence, Morbidity and Mortality .............................3                   DIAGNOSTIC CHALLENGES AND




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      Social and Economic Burden .......................................3                   DIFFERENTIAL DIAGNOSIS.......................................20




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                                                                                              Children 5 Years and Younger ...................................20
    FACTORS INFLUENCING THE DEVELOPMENT AND
                                                                                              Older Children and Adults ..........................................20
     EXPRESSION OF ASTHMA..........................................4



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                                                                                              The Elderly .................................................................21
      Host Factors................................................................4
                                                                                              Occupational Asthma .................................................21
        Genetic.....................................................................4
                                                                                            T Distinguishing Asthma from COPD ............................21
        Obesity .....................................................................5
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        Sex ...........................................................................5
                                                                                           CLASSIFICATION OF ASTHMA.....................................22
      Environmental Factors ................................................5
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        Allergens ..................................................................5        Etiology ......................................................................22
                                                                                             Phenotype..................................................................22
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        Infections ..................................................................5
        Occupational sensitizers...........................................5                 Asthma Control ..........................................................22
                                                                          -D




        Tobacco smoke ........................................................6              Asthma Severity .........................................................23
        Outdoor/Indoor air pollution ......................................6
                                                                                           REFERENCES ...............................................................23
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        Diet...........................................................................7
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    MECHANISMS OF ASTHMA............................................7                      CHAPTER 3. ASTHMA MEDICATIONS ........................27
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      Airway Inflammation In Asthma ....................................7
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         Inflammatory cells ....................................................7          KEY POINTS ..................................................................28
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         Inflammatory mediators ............................................7
         Structural changes in the airways .............................8                  INTRODUCTION ............................................................28
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      Pathophysiology...........................................................8
         Airway hyperresponsiveness....................................8                   ASTHMA MEDICATIONS: ADULTS ...............................28
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      Special Mechanisms ....................................................8               Route of Administration ..............................................28
         Acute exacerbations .................................................8              Controller Medications................................................29
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         Nocturnal asthma .....................................................9               Inhaled glucocorticosteroids ...................................29
         Irreversible airflow limitation .....................................9                Leukotriene modifiers .............................................30
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         Difficult-to-treat asthma ............................................9               Long-acting inhaled 2-agonists .............................30
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         Smoking and asthma................................................9                   Theophylline ...........................................................31
                                                                                               Cromones: sodium cromoglycate and
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    REFERENCES .................................................................9                     nedocromil sodium........................................31
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                                                                                               Long-acting oral 2-agonists...................................32
    CHAPTER 2. DIAGNOSIS AND CLASSIFICATION .....15                                            Anti-IgE ..................................................................32
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                                                                                               Systemic glucocorticosteroids ................................32
    KEY POINTS ..................................................................16
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                                                                                               Oral anti-allergic compounds ..................................32
    INTRODUCTION ............................................................16                Other controller therapies .......................................32
                                                                                               Allergen-specific immunotherapy............................33

                                                                                                                                                                           iii
Reliever Medications ...................................................34
           Rapid-acting inhaled 2-agonists............................34                ASTHMA PREVENTION.................................................54
           Systemic glucocorticosteroids ................................34
           Anticholinergics ......................................................34    PREVENTION OF ASTHMA SYMPTOMS AND




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           Theophylline ...........................................................35      EXACERBATIONS....................................................55
           Short-acting oral 2-agonists..................................35




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                                                                                           Indoor Allergens .......................................................55
         Complementary and Alternative Medicine ...................35                        Domestic mites.......................................................55




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                                                                                             Furred animals .......................................................55




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    ASTHMA TREATMENT: CHILDREN .............................35                               Cockroaches ..........................................................55




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      Route of Administration ..............................................35               Fungi ......................................................................56




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      Controller Medications................................................36            Outdoor Allergens ......................................................56
        Inhaled glucocorticosteroids ...................................36                Indoor Air Pollutants ..................................................56




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        Leukotriene modifiers .............................................38             Outdoor Air Pollutants ................................................56
        Long-acting inhaled 2-agonists .............................38                    Occupational Exposures ............................................56




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        Theophylline ...........................................................39        Food and Food Additives ...........................................56
        Cromones: sodium cromoglycate and nedocromil




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                                                                                          Drugs .........................................................................57
               sodium .........................................................39         Influenza Vaccination .................................................57




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        Long-acting oral 2-agonists...................................39                  Obesity.......................................................................57




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        Systemic glucocorticosteroids ................................39                  Emotional Stress ........................................................57
      Reliever Medications ...................................................40          Other Factors That May Exacerbate Asthma .............57




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        Rapid-acting inhaled 2-agonists and short-acting
             oral 2-agonists ..............................................40           COMPONENT 3: ASSESS, TREAT AND MONITOR



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        Anticholinergics ......................................................40        ASTHMA......................................................................57

    REFERENCES ...............................................................40         T
                                                                                        KEY POINTS ..................................................................57
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    CHAPTER 4. ASTHMA MANAGEMENT AND
                                                                                        N

                                                                                        INTRODUCTION ............................................................57
    PREVENTION ................................................................49
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                                                                                        ASSESSING ASTHMA CONTROL.................................58
    INTRODUCTION ............................................................50
                                                                       -D




                                                                                        TREATING TO ACHIEVE CONTROL.............................58
    COMPONENT 1: DEVELOP PATIENT/                                                         Treatment Steps for Achieving Control........................58
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     DOCTOR PARTNERSHIP...........................................50                         Step 1: As-needed reliever medication ..................58
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                                                                                             Step 2: Reliever medication plus a single
    KEY POINTS ..................................................................50              controller .........................................................60
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                                                                                             Step 3: Reliever medication plus one or two
                                               E




    INTRODUCTION ............................................................50                  controllers .......................................................60
                                            AT




                                                                                             Step 4: Reliever medication plus two or more
    ASTHMA EDUCATION...................................................51                        controllers .......................................................61
                                       M




      At the Initial Consultation...........................................52               Step 5: Reliever medication plus additional
      Personal Asthma Action Plans ..................................52                          controller options ............................................61
                           D




      Follow-up and Review ...............................................52
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      Improving Adherence ................................................52            MONITORING TO MAINTAIN CONTROL ......................61
      Self-Management in Children ....................................52                 Duration and Adjustments to Treatment ......................61
                     H




                                                                                         Stepping Down Treatment When Asthma Is
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    THE EDUCATION OF OTHERS.....................................53                        Controlled.................................................................62
                                                                                         Stepping Up Treatment In Response To Loss Of
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    COMPONENT 2: IDENTIFY AND REDUCE EXPOSURE                                             Control .....................................................................62
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     TO RISK FACTORS ....................................................54              Difficult-to-Treat-Asthma .............................................63
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    KEY POINTS ..................................................................54
                                                                                        COMPONENT 4 - MANAGE ASTHMA
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    INTRODUCTION ............................................................54          EXACERBATIONS ......................................................64


    iv
Utilization and Cost of Health Care Resources.........89
    KEY POINTS ..................................................................64             Determining the Economic Value of Interventions in
                                                                                                 Asthma ...................................................................90
    INTRODUCTION ............................................................64




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                                                                                           GINA DISSEMINATION/IMPLEMENTATION




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    ASSESSMENT OF SEVERITY.......................................65                          RESOURCES ............................................................90




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    MANAGEMENT–COMMUNITY SETTINGS ...................65                                    REFERENCES ...............................................................91




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      Treatment...................................................................66




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        Bronchodilators ......................................................66




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        Glucocorticosteroids ...............................................66




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    MANAGEMENT–ACUTE CARE SETTINGS ..................66
      Assessment ................................................................66




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      Treatment....................................................................68




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          Oxygen...................................................................68
          Rapid-acting inhaled 2–agonists...........................68




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          Epinephrine ............................................................68




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      Additional bronchodilators ...........................................68




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          Systemic glucocorticosteroids ................................68
          Inhaled glucocorticosteroids ...................................69
          Magnesium.............................................................69



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          Helium oxygen therapy...........................................69
          Leukotriene modifiers .............................................69             T
          Sedatives ...............................................................69
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     Criteria for Discharge from the Emergency
                                                                                           N

        Department vs. Hospitalization.................................69
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    COMPONENT 5. SPECIAL CONSIDERATIONS ..........70
                                                                          -D




     Pregnancy.....................................................................70
     Surgery .........................................................................70
     Rhinitis, Sinusitis, And Nasal Polyps .............................71
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         Rhinitis ...................................................................71
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         Sinusitis ..................................................................71
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         Nasal polyps...........................................................71
     Occupational Asthma ....................................................71
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     Respiratory Infections ...................................................72
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     Gastroesophageal Reflux..............................................72
     Aspirin-Induced Asthma ................................................72
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     Anaphylaxis and Asthma...............................................73
                           D




    REFERENCES ...............................................................73
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    CHAPTER 5. IMPLEMENTATION OF ASTHMA
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     GUIDELINES IN HEALTH SYSTEMS .........................87
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    KEY POINTS ..................................................................88
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    INTRODUCTION ............................................................88
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    GUIDELINE IMPLEMENTATION STRATEGIES ............88
    ECONOMIC VALUE OF INTERVENTIONS AND
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      GUIDELINE IMPLEMENTATION IN ASTHMA...........89


                                                                                                                                                                           v
METHODOLOGY AND SUMMARY OF NEW
               RECOMMENDATIONS GLOBAL STRATEGY FOR




                                                                                                                                                                E
              ASTHMA MANAGEMENT AND PREVENTION: 2009




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                                                                                                                                                              U
                            UPDATE*




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                                                                                                                                                     O
    When the Global Initiative for Asthma (GINA) program was                               discuss each publication that was felt would have an
    initiated in 1993, the primary goal was to produce                                     impact on asthma management and prevention by at least




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    recommendations for asthma management based on the                                     1 member of the Committee, and to reach a consensus on




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    best scientific information available. Its first report,                               the changes in the report. In the absence of consensus
    NHLBI/WHO Workshop Report: Global Strategy for                                         disagreements were decided by an open vote of the full




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    Asthma Management and Prevention was issued in 1995                                    committee.
    and revised in 2002 and 2006. These reports, and their




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    companion documents, have been widely distributed and                                  Summary of Recommendations in the 2009 Update:




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    translated into many languages. The 2006 report was                                    Between July 1, 2008 and June 30, 2009, 392 articles met
    based on research published through June, 2006 and can                                 the search criteria; 10 additional publications were brought




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    be found on the GINA website (www.ginasthma.org).                                      to the attention of the committee. Of the 402 articles, 23




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                                                                                           papers were identified as having an impact on the GINA
    The GINA Science Committee was established in 2002 to                                  Report (updated 2009) that was posted on the website in
    review published research on asthma management and                                     December 2009 either by: 1) confirming, that is, adding to



                                                                                                    AL
    prevention, to evaluate the impact of this research on                                 or replacing an existing reference, or 2) modifying, that is,
    recommendations in the GINA documents related to                                       changing the text or introducing a concept requiring a new
    management and prevention, and to post yearly updates
                                                                                          Trecommendation to the report. The summary is reported
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    on the GINA website. The first update of the 2006 report                               in three segments: A) Modifications in the text; B)
    (2007 update) included the impact of publications from                                 References that provided confirmation or an update of
                                                                                     N

    July 1, 2006 through June 30, 2007; the 2008 updated                                   previous recommendations; and C) Changes or
                                                                        O


    included the impact of publications from July 1, 2007                                  modifications to the text.
    through June 30, 2008. This 2009 update includes the
                                                                      -D




    impact of publications from July 1, 2008 through June 30,                              Asthma in Children 5 Years and Younger: In 2008, a
    2009.                                                                                  number of pediatric experts developed a report which
                                                          L




                                                                                           focused on asthma care in children 5 years and younger.
                                                        IA




    Methods: The methodology used to produce this 2009                                     The Global Strategy for Asthma Management and
    update included a Pub Med search using search fields                                   Prevention in Children 5 Years and Younger was released
                                                       R




    established by the Committee: 1) asthma, All Fields, All                               in early 2009 (can be found on www.ginasthma.org).
                                              E




    ages, only items with abstracts, Clinical Trial, Human,                                Accordingly, the Executive Summary “Managing Asthma in
                                           AT




    sorted by Authors; and 2) asthma AND systematic, All                                   Children 5 Years and Younger” that appeared on pages
    fields, ALL ages, only items with abstracts, Human, sorted                             xiv – xvii is deleted – see section C.
    by author. In addition, publications in peer review journals
                                      M




    not captured by Pub Med could be submitted to individual                               Asthma Control: In review of the published literature, the
                          D




    members of the Committee providing an abstract and the                                 Committee determined that many changes were required
    full paper were submitted in (or translated into) English.                             in the segment “Classification of Asthma.” Accordingly, a
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                                                                                           new segment appears beginning on page 22 – see section
    All members of the Committee received a summary of                                     D.1).
                   H




    citations and all abstracts. Each abstract was assigned to
             IG




    at least two Committee members, although all members                                   Evidence Reviews: In the preparation of GINA reports,
    were offered the opportunity to provide an opinion on any                              including this 2009 update, levels of evidence has been
         R




    abstract. Members evaluated the abstract or, up to her/his                             completed using four categories as described on page xiii.
PY




    judgment, the full publication, by answering specific written                          The committee has had extensive discussions internally,
    questions from a short questionnaire, and to indicate if the                           as well as with proponents of a new methodology for
    scientific data presented impacted on recommendations in                               describing recommendations (the GRADE system). The
O




    the GINA report. If so, the member was asked to                                        implications for the widespread adaptation of this system
C




    specifically identify modifications that should be made. The                           has been explored by the Committee with regard to
    entire GINA Science Committee met twice yearly to                                      resource implications, especially given the already

    vi
    * The Global Strategy for Asthma Management and Prevention (updated 2009), the updated Pocket Guides and the complete list of references examined by the Committee are
      available on the GINA website www.ginasthma.org.
    † Members (2008-2009): M. FitzGerald, Chair; P. Barnes, N. Barnes, E. Bateman, A. Becker, J. Drazen, R. Lemanske, P. O’Byrne, K. Ohta, S. Pedersen, E. Pizzichini, H.
      Reddel, S. Sullivan, S. Wenzel, H. Zar.
rigorous method of reviewing the literature and updating           AS, Buist AS, et al. Asthma drug use and the
    recommendations that is currently in place. The                    development of Churg-Strauss syndrome (CSS).
    committee has decided that it would be inappropriate to            Pharmcoepidemiology and Drug Safety. 2007;16:620-26.
    implement this methodology for all the recommendations




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    within GINA and recommended instead to use the method-             Pg 31, left column, paragraph 1, insert: …does not




                                                                                                                             C
    ology, selectively, especially where the balance between           increase the risk of asthma-related hospitalizations214 …




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    efficacy and cost effectiveness is unclear or where there is       Reference 214. Jaeschke R, O'Byrne PM, Mejza F, Nair
    controversy with regard to the recommendation. The                 P, Lesniak W, Brozek J, Thabane L, Cheng J,




                                                                                                                      D
    Committee applied GRADE to two questions (see section              Schünemann HJ, Sears MR, Guyatt G. The safety of long-




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    D.2) and will continue to explore the use of GRADE-like            acting beta-agonists among patients with asthma using




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    methodology for issues that require more in-depth                  inhaled corticosteroids: systematic review and




                                                                                                           EP
    evaluation.                                                        metaanalysis. Am J Respir Crit Care Med. 2008 Nov
                                                                       15;178(10):1009-16. Epub 2008 Sep 5.
    A. Modifications in the text:




                                                                                                       R
                                                                       Pg 34, left column, end of paragraph 1, insert: Data on a




                                                                                               R
    Pg 19, right column, insert end of first paragraph: although       human monoclonal antibody against tumor necrosis factor
    it has been shown that the use of FeNo as a measure of             (TNF)-alpha suggest that the risk benefit equation does




                                                                                              O
    asthma control does not improve control or enable                  not favor the use of this class of treatments in severe




                                                                                      R
    reduction in dose of inhaled glucocorticosteroid55.                asthma216. Reference 216. Wenzel SE, Barnes PJ,
    Reference 55. Szefler SJ, Mitchell H, Sorkness CA,                 Bleecker ER, Bousquet J, Busse W, Dahlén SE, et al; T03




                                                                                   TE
    Gergen PJ, O'Connor GT, Morgan WJ, et al. Management               Asthma Investigators. A randomized, double-blind,
    of asthma based on exhaled nitric oxide in addition to             placebo-controlled study of tumor necrosis factor-alpha



                                                                             AL
    guideline-based treatment for inner-city adolescents and           blockade in severe persistent asthma. Am J Respir Crit
    young adults: a randomised controlled trial. Lancet. 2008          Care Med. 2009 Apr 1;179(7):549-58. Epub 2009 Jan 8.
    Sep 20;372(9643):1065-72.                                           T
                                                                       Pg 35, right column, beginning of paragraph 4, insert:
                                                                       O
    Pg 30, left column, line 6, insert: although there appear to       Dietary supplements, including selenium therapy197 are not
                                                                       N

    be differences in response according to                            of proven benefit and the use of a low sodium diet as an
    symptom/inflammation phenotype212. Reference 212.                  adjunctive therapy to normal treatment has no additional
                                                           O


    Haldar P, Pavord ID, Shaw DE, Berry MA, Thomas M,                  therapeutic benefit in adults with asthma. In addition it has
                                                         -D




    Brightling CE, Wardlaw AJ, Green RH. Cluster analysis              no effect on bronchial reactivity to methacholine217.
    and clinical asthma phenotypes. Am J Respir Crit Care              Reference 217. Pogson ZE, Antoniak MD, Pacey SJ,
    Med. 2008 Aug 1;178(3):218-24. Epub 2008 May 14                    Lewis SA, Britton JR, Fogarty AW. Does a low sodium
                                                L




                                                                       diet improve asthma control? A randomized controlled trial.
                                              IA




    Pg 30, left column, line 11 from end, insert: A meta-              Am J Respir Crit Care Med. 2008 Jul 15;178(2):132-8.
                                             R




    analysis of case-control studies of non-vertebral fractures        Epub 2008 May 1.
    in adults using inhaled glucocorticosteroids (BDP or
                                       E




    equivalent) indicated that in older adults, the relative risk of   Pg 38, Figure 3.6, delete last statement and insert:
                                    AT




    non-vertebral fractures increases by about 12% for each            Inhaled glucocorticosteroid use has the potential for
    1000 µg/day increase in the dose BDP or equivalent but             reducing bone mineral accretion in male children
                               M




    that the magnitude of this risk was considerably less than         progressing through puberty, but this risk is likely to be out-
    other common risk factors for fracture in the older                weighed by the ability to reduce the amount of oral
                      D




    adult213. Reference 213. Weatherall M, James K, Clay               corticosteroids used in these children218. Reference 218.
                    TE




    J, Perrin K, Masoli M, Wijesinghe M, Beasley R. Dose-              Kelly HW, Van Natta ML, Covar RA, Tonascia J, Green
    response relationship for risk of non-vertebral fracture with      RP, Strunk RC; CAMP Research Group. Effect of long-
                H




    inhaled corticosteroids. Clin Exp Allergy. 2008                    term corticosteroid use on bone mineral density in
           IG




    Sep;38(9):1451-8. Epub 2008 Jun 3.                                 children: a prospective longitudinal assessment in the
                                                                       childhood Asthma Management Program (CAMP) study.
       R




    Pg 30, right column, last paragraph delete last sentence           Pediatrics. 2008 Jul;122(1):e53-61.
    and references 52-54 and replace with: No association
PY




    was found between Churg-Strauss syndrome and                       Pg 39, left column, end of first paragraph, insert:
    leukotriene modifiers, after controlling for asthma drug use,      Montelukast has not been demonstrated to be an effective
O




    although it is not possible to rule out modest associations        inhaled glucocorticosteroid sparing alternative in children
C




    given that Churg-Strauss syndrome is so rare and so                with moderate-to-severe persistent asthma219. Reference
    highly correlated with asthma severity52. New Reference            219. Strunk RC, Bacharier LB, Phillips BR, Szefler SJ,
    52. Harrold LR, Patterson K, Andrade SE, Dube T, Go                Zeiger RS, Chinchilli VM, et al.; CARE Network.

                                                                                                                                   vii
Azithromycin or montelukast as inhaled corticosteroid-         blockers, within 24 hours of hospital admission, for an
    sparing agents in moderate-to-severe childhood asthma          acute coronary event, have lower in-hospital mortality
    study. J Allergy Clin Immunol. 2008 Dec;122(6):1138-           rates366, 367. Reference 366. Babu KS, Gadzik F, Holgate
    1144.e4. Epub 2008 Oct 25.                                     ST. Absence of respiratory effects with ivabradine in




                                                                                                                           E
                                                                   patients with asthma. Br J Clin Pharmacol. 2008




                                                                                                                          C
    Pg 51, right column, end of last paragraph, insert: Lay        Jul;66(1):96-101. Epub 2008 Mar 13. Reference 367.




                                                                                                                         U
    educators can be recruited and trained to deliver a discrete   Olenchock BA, Fonarow GG, Pan W, Hernandez A,




                                                                                                                  D
    area of respiratory care (for example, asthma self-            Cannon CP; Get With The Guidelines Steering Committee.
    management education) with comparable outcomes to              Current use of beta blockers in patients with reactive




                                                                                                                 O
    those achieved by primary care based practice nurses362        airway disease who are hospitalized with acute coronary




                                                                                                              R
    (Evidence B).                                                  syndromes. Am J Cardiol. 2009 Feb 1;103(3):295-300.




                                                                                                       EP
    Reference 362. Partridge MR, Caress AL, Brown C,               Epub 2008 Nov 19.
    Hennings J, Luker K, Woodcock A, Campbell M. Can lay
    people deliver asthma self-management education as             Pg 62, left column, last paragraph, delete sentence and




                                                                                                    R
    effectively as primary care based practice nurses?             replace with: However, this is more likely to lead to loss of




                                                                                            R
    Thorax. 2008 Sep;63(9):778-83. Epub 2008 Feb 15.)              asthma control137, 368 (Evidence B). Reference 368:
                                                                   Godard P, Greillier P, Pigearias B, Nachbaur G,




                                                                                           O
    Pg 52, right column, last paragraph, delete first sentence     Desfougeres JL, Attali V. Maintaining asthma control in




                                                                                  R
    and replace with: Although interventions for enhancing         persistent asthma: comparison of three strategies in a 6-
    medication adherence have been developed363, studies of        month double-blind randomised study. Respir Med. 2008




                                                                               TE
    adults and children with asthma34 have shown that around       Aug;102(8):1124-31. Epub 2008 Jul 7.
    50% of those on long-term therapy fail to take medications



                                                                         AL
    as directed at least part of the time. Reference 363.          Pg 72, left column, end of third paragraph, insert: Adults
    Haynes RB, Ackloo E, Sahota N, McDonald HP, Yao X.             with asthma may be at increased risk of serious
    Interventions for enhancing medication adherence.               T
                                                                   pneumococcal disease370. Reference 370. Juhn YJ, Kita
                                                                   O
    Cochrane Database Syst Rev. 2008 Apr 16;(2):CD000011           H, Yawn BP, Boyce TG, Yoo KH, McGree ME, Weaver AL,
                                                                   Wollan P, Jacobson RM. Increased risk of serious
                                                                   N

    Pg 55, left column, end of first paragraph, insert: Patients   pneumococcal disease in patients with asthma. J Allergy
    with well-controlled asthma are less likely to experience      Clin Immunol. 2008 Oct;122(4):719-23. Epub 2008 Sep
                                                         O


    exacerbations than those whose asthma is not well-             13.
                                                       -D




    controlled364.
    Reference 364: Bateman ED, Bousquet J, Busse WW,               Pg 89, right column, first paragraph, insert: Use of
    Clark TJ, Gul N, Gibbs M, Pedersen S; GOAL Steering            administrative datasets (e.g., dispensing records) or urgent
                                              L




    Committee and Investigators. Stability of asthma control       health care utilization can help to identify at-risk patients or
                                            IA




    with regular treatment: an analysis of the Gaining Optimal     to audit the quality of health care23. Reference 23.
                                           R




    Asthma controL (GOAL) study. Allergy. 2008                     Bereznicki BJ, Peterson GM, Jackson SL, Walters EH,
                                     E




    Jul;63(7):932-8.                                               Fitzmaurice KD, Gee PR. Data-mining of medication
                                                                   records to improve asthma management. Med J Aust.
                                  AT




    Pg 56, left column, end of third paragraph delete as           2008 Jul 7;189(1):21-5.
    indicated and insert: Installation of non-polluting, more
                              M




    effective heating (heat pump, wood pellet burner, flued        B. References that provided confirmation or update of
    gas) in the homes of children with asthma does not             previous recommendations:
                     D




    significantly improve lung function but does significantly
                   TE




    reduce symptoms of asthma, days off school, healthcare         Pg 24: Right column, replace reference 32. Horvath I,
    utilization, and visits to a pharmacist365.                    Hunt J, Barnes PJ, Alving K, Antczak A, Baraldi E, et al.
                H




    Reference 365. Howden-Chapman P, Pierse N, Nicholls            Exhaled breath condensate: methodological
                                                                   recommendations and unresolved questions. Eur Respir J
           IG




    S, Gillespie-Bennett J, Viggers H, Cunningham M, et al.
    Effects of improved home heating on asthma in community        2005;26:523-48.
           R




    dwelling children: randomized controlled trial. BMJ. 2008
                                                                   Pg 30: Left column, insert reference 211. O'Byrne PM,
PY




    Sep 23;337:a1411. doi: 10.1136/bmj.a1411.
                                                                   Naya IP, Kallen A, Postma DS, Barnes PJ. Increasing
    Pg 57, left column, end of first paragraph, insert: Beta       doses of inhaled corticosteroids compared to adding long-
O




    blockers have a proven benefit in the management of            acting inhaled beta2-agonists in achieving asthma control.
C




    patients with acute coronary syndromes and for secondary       Chest. 2008 Dec;134(6):1192-9. Epub 2008 Aug 8.
    prevention of coronary events. Data suggest that patients
    with asthma who receive newer more cardio-selective beta

    viii
Pg 31: right column, insert reference 215. Cates CJ,          Asthma Management and Prevention in Children 5 Years
    Cates MJ. Regular treatment with salmeterol for chronic       and Younger. Available at www.ginasthma.org
    asthma: serious adverse events. Cochrane Database of
    Systematic Reviews 2008, Issue 3. Art. No.: CD006363          Pg 61, right column, second paragraph: Change Evidence




                                                                                                                     E
                                                                  A to Evidence B.




                                                                                                                    C
    Pg 70, right column, second paragraph, insert reference




                                                                                                                   U
    369. Tata LJ, Lewis SA, McKeever TM, Smith CJ, Doyle          Pg 70, right column, second paragraph, first phrase delete
    P, Smeeth L, Gibson JE, Hubbard RB. Effect of maternal        and replace with: Although there is a general concern




                                                                                                             D
    asthma, exacerbations and asthma medication use on            about the use of any medication in pregnancy,….




                                                                                                            O
    congenital malformations in offspring: a UK population-




                                                                                                         R
    based study. Thorax. 2008 Nov;63(11):981-7. Epub 2008         D. Committee recommended changes:




                                                                                                   EP
    Aug 4.
                                                                  1. Asthma Control: Based on a number of recent
    Pg 70, right column, second paragraph, replace reference      publications, the Committee recommended significant




                                                                                                R
    268. Bakhireva LN, Schatz M, Jones KL, Chambers CD;           changes to the section on Classification of Asthma, pages
    Organization of Teratology Information Specialists            22 – 23. Figure 2-4 has been deleted. Former Figure 2-5




                                                                                         R
    Collaborative Research Group. Asthma control during           (now appears as Figure 2-4), has been modified. This




                                                                                        O
    pregnancy and the risk of preterm delivery or impaired        modified Figure also appears on page 58 (as Figure 4.3-
    fetal growth. Ann Allergy Asthma Immunol. 2008                1).




                                                                                R
    Aug;101(2):137-43




                                                                             TE
                                                                  2. Grading Evidence: The GINA Science Committee is
    Pg 71, left column, third paragraph, replace reference 279.   developing a system to identify recommendations where




                                                                        AL
    Shaaban R, Zureik M, Soussan D, Neukirch C, Heinrich J,       there maybe controversy or debate between efficacy and
    Sunyer J, et al. Rhinitis and onset of asthma: a              cost. In addition there are some recommendations that
    longitudinal population-based study. Lancet. 2008 Sep         have a less robust evidence base. In this context we see a
                                                                   T
    20;372(9643):1049-57.                                         possible role for the GRADE methodology providing a
                                                                  O
                                                                  framework collate the evidence and create evidence
                                                                  N

    Pg 78, delete reference 150.                                  tables. To assess the feasibility of this approach two
                                                                  questions were reviewed in 2009 to begin the work:
                                                       O


    C. Changes or modifications to the text.
                                                     -D




                                                                  a. In adults with asthma, does monoclonal anti-IgE,
    Pg xiv – xvii: Delete section Executive Summary:                 omalizumab, compared to placebo improve patient out-
    Managing Asthma in Children 5 Years and Younger. This            comes?
                                            L




    has been replaced with new report Global Strategy for
                                          IA




    Asthma Management and Prevention in Children 5 Years          b. In adults with acute exacerbations of asthma, does
    and Younger.                                                     intravenous magnesium sulphate compared to placebo
                                         R




                                                                     improve patient important outcomes?
                                      E




    Pg 28, left column line 10, delete: and other systemic
                                   AT




    steroid-sparing therapies.                                    Evidence tables were produced and are being evaluated
                                                                  and the results from this work are being prepared for
    Pg 29, Figure 3-1: Change Fluticasone to Fluticasone          publication. Further information will be provided in the
                             M




    propionate.                                                   2010 update.
                    D




    Pg 31, left column, end of paragraph 2, insert: See
                  TE




    Appendix B, GINA Pocket Guide updated 2009 for
    information on Asthma Combination Medications For
               H




    Adults and Children 5 Years and Older.
          IG




    Pg 31, left column, beginning of paragraph 3, insert:
       R




    …when used as a combination medication with inhaled
PY




    glucocorticosteroids…

    Pg 37, Figure 3-4: Change Fluticasone to Fluticasone
O




    propionate.
C




    Pg 59, Figure 4.3-2: Modifications to clarify wording on
    Figure; modify lower segment to read Global Strategy for

                                                                                                                             ix
INTRODUCTION
    Asthma is a serious public health problem throughout the       aim to enhance communication with asthma specialists,




                                                                                                                          E
    world, affecting people of all ages. When uncontrolled,        primary-care health professionals, other health care




                                                                                                                         C
    asthma can place severe limits on daily life, and is           workers, and patient support organizations. The Executive
    sometimes fatal.                                               Committee continues to examine barriers to implementation




                                                                                                                        U
                                                                   of the asthma management recommendations, especially




                                                                                                                 D
    In 1993, the Global Initiative for Asthma (GINA) was           the challenges that arise in primary-care settings and in




                                                                                                                O
    formed. Its goals and objectives were described in a 1995      developing countries.




                                                                                                             R
    NHLBI/WHO Workshop Report, Global Strategy for




                                                                                                      EP
    Asthma Management and Prevention. This Report                  While early diagnosis of asthma and implementation of
    (revised in 2002), and its companion documents, have           appropriate therapy significantly reduce the socioeconomic
    been widely distributed and translated into many               burdens of asthma and enhance patients’ quality of life,




                                                                                                   R
    languages. A network of individuals and organizations          medications continue to be the major component of the




                                                                                           R
    interested in asthma care has been created and several         cost of asthma treatment. For this reason, the pricing of
    country-specific asthma management programs have               asthma medications continues to be a topic for urgent




                                                                                          O
    been initiated. Yet much work is still required to reduce      need and a growing area of research interest, as this has




                                                                                  R
    morbidity and mortality from this chronic disease.             important implications for the overall costs of asthma




                                                                               TE
                                                                   management.
    In January 2004, the GINA Executive Committee
    recommended that the Global Strategy for Asthma                Moreover, a large segment of the world’s population lives



                                                                         AL
    Management and Prevention be revised to emphasize              in areas with inadequate medical facilities and meager
    asthma management based on clinical control, rather than       financial resources. The GINA Executive Committee
                                                                    T
    classification of the patient by severity. This important      recognizes that “fixed” international guidelines and “rigid”
                                                                   O
    paradigm shift for asthma care reflects the progress that      scientific protocols will not work in many locations. Thus,
                                                                   N

    has been made in pharmacologic care of patients. Many          the recommendations found in this Report must be
    asthma patients are receiving, or have received, some          adapted to fit local practices and the availability of health
                                                        O


    asthma medications. The role of the health care                care resources.
                                                      -D




    professional is to establish each patient’s current level of
    treatment and control, then adjust treatment to gain and       As the GINA Committees expand their work, every effort
    maintain control. This means that asthma patients should       will be made to interact with patient and physician groups
                                             L




    experience no or minimal symptoms (including at night),        at national, district, and local levels, and in multiple health
                                           IA




    have no limitations on their activities (including physical    care settings, to continuously examine new and innovative
                                          R




    exercise), have no (or minimal) requirement for rescue         approaches that will ensure the delivery of the best asthma
    medications, have near normal lung function, and               care possible. GINA is a partner organization in a program
                                    E




    experience only very infrequent exacerbations.                 launched in March 2006 by the World Health Organization,
                                 AT




                                                                   the Global Alliance Against Chronic Respiratory Diseases
    FUTURE CHALLENGES                                              (GARD). Through the work of the GINA Committees, and
                             M




                                                                   in cooperation with GARD initiatives, progress toward
    In spite of laudable efforts to improve asthma care over the   better care for all patients with asthma should be
                     D




    past decade, a majority of patients have not benefited from    substantial in the next decade.
                   TE




    advances in asthma treatment and many lack even the
    rudiments of care. A challenge for the next several years      METHODOLOGY
               H




    is to work with primary health care providers and public
          IG




    health officials in various countries to design, implement,    A. Preparation of yearly updates: Immediately
    and evaluate asthma care programs to meet local needs.         following the release of an updated GINA Report in 2002,
        R




    The GINA Executive Committee recognizes that this is a         the Executive Committee appointed a GINA Science
PY




    difficult task and, to aid in this work, has formed several    Committee, charged with keeping the Report up-to-date
    groups of global experts, including: a Dissemination Task      by reviewing published research on asthma management
O




    Group; the GINA Assembly, a network of individuals who         and prevention, evaluating the impact of this research on
    care for asthma patients in many different health care         the management and prevention recommendations in the
C




    settings; and regional programs (the first two being GINA      GINA documents, and posting yearly updates of these
    Mesoamerica and GINA Mediterranean). These efforts             documents on the GINA website. The first update was

    x
posted in October 2003, based on publications from              as possible, while at the same time recognizing that one of
    January 2000 through December 2002. A second update             the values of the GINA Report has been to provide
    appeared in October 2004, and a third in October 2005,          background information about asthma management and
    each including the impact of publications from January          the scientific information on which management




                                                                                                                          E
    through December of the previous year.                          recommendations are based.




                                                                                                                         C
                                                                                                                        U
    The process of producing the yearly updates began with a        In January 2006, the Committee met again for a two-day




                                                                                                                  D
    Pub Med search using search fields established by the           session during which another in-depth evaluation of each




                                                                                                                 O
    Committee: 1) asthma, All Fields, All ages, only items with     chapter was conducted. At this meeting, members
    abstracts, Clinical Trial, Human, sorted by Authors; and        reviewed the literature that appeared in 2005—using the




                                                                                                             R
    2) asthma AND systematic, All fields, ALL ages, only items      same criteria developed for the update process. The list




                                                                                                       EP
    with abstracts, Human, sorted by Author. In addition,           of 285 publications from 2005 that were considered is
    peer-reviewed publications not captured by Pub Med could        posted on the GINA website. At the January meeting, it




                                                                                                   R
    be submitted to individual members of the Committee             was clear that work remaining would permit the report to
    providing an abstract and the full paper were submitted in      be finished during the summer of 2006 and, accordingly,




                                                                                            R
    (or translated into) English.                                   the Committee requested that as publications appeared




                                                                                           O
                                                                    throughout early 2006, they be reviewed carefully for their
    All members of the Committee received a summary of              impact on the recommendations. At the Committee’s next




                                                                                   R
    citations and all abstracts. Each abstract was assigned to      meeting in May, 2006 publications meeting the search




                                                                                TE
    two Committee members, and an opportunity to provide an         criteria were considered and incorporated into the current
    opinion on any single abstract was offered to all members.      drafts of the chapters, where appropriate. A final meeting



                                                                          AL
    Members evaluated the abstract or, up to her/his                of the Committee was held in September 2006, at which
    judgment, the full publication, by answering specific written   publications that appear prior to July 31, 2006 were
    questions from a short questionnaire, indicating whether         T
                                                                    considered for their impact on the document.
                                                                    O
    the scientific data presented affected recommendations in
    the GINA Report. If so, the member was asked to                 Periodically throughout the preparation of this report,
                                                                    N

    specifically identify modifications that should be made.        representatives from the GINA Science Committee have
                                                         O


    The entire GINA Science Committee met on a regular              met with members of the GINA Assembly (May and
    basis to discuss each individual publication that was           September, 2005 and May 2006) to discuss the overall
                                                       -D




    judged by at least one member to have an impact on              theme of asthma control and issues specific to each of the
    asthma management and prevention recommendations,               chapters. The GINA Assembly includes representatives
                                              L




    and to reach a consensus on the changes in the Report.          from over 50 countries and many participated in these
                                            IA




    Disagreements were decided by vote.                             interim discussions. In addition, members of the Assembly
                                                                    were invited to submit comments on a DRAFT document
                                           R




    The publications that met the search criteria for each          during the summer of 2006. Their comments, along with
                                     E




    yearly update (between 250 and 300 articles per year)           comments received from several individuals who were
                                  AT




    mainly affected the chapters related to clinical                invited to serve as reviewers, were considered by the
    management. Lists of the publications considered by the         Committee in September, 2006.
                              M




    Science Committee each year, along with the yearly
    updated reports, are posted on the GINA website,                Summary of Major Changes
                     D




    www.ginasthma.org.
                   TE




                                                                    The major goal of the revision was to present information
    B. Preparation of new 2006 report: In January 2005,             about asthma management in as comprehensive manner
                H




    the GINA Science Committee initiated its work on this new       as possible but not in the detail that would normally be
           IG




    report. During a two-day meeting, the Committee                 found in a textbook. Every effort has been made to select
    established that the main theme of the new report should        key references, although in many cases, several other
       R




    be the control of asthma. A table of contents was               publications could be cited. The document is intended to
PY




    developed, themes for each chapter identified, and writing      be a resource; other summary reports will be prepared,
    teams formed. The Committee met in May and September            including a Pocket Guide specifically for the care of infants
    2005 to evaluate progress and to reach consensus on             and young children with asthma.
O




    messages to be provided in each chapter. Throughout its
C




    work, the Committee made a commitment to develop a
    document that would: reach a global audience, be based
    on the most current scientific literature, and be as concise
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Gina report ASMA - Inglés

  • 1. E C U D O R EP R R O R TE AL T O N O -D ® L IA RE AT M D TE H IG GLOBAL STRATEGY FOR R ASTHMA MANAGEMENT AND PREVENTION PY O UPDATED 2009 C
  • 2. E C U D O R EP R R O R TE AL T O N O -D L IA E R AT M D TE H IG R PY O C Global Strategy for Asthma Management and Prevention The GINA reports are available on www.ginasthma.org.
  • 3. Global Strategy for Asthma Management and Prevention 2009 (update) GINA ExEcutIvE commIttEE* GINA ScIENcE commIttEE* E Eric D. Bateman, MD, Chair Mark FitzGerald, MD, Chair C University Cape Town Lung Institute University of British Columbia U Cape Town, South Africa Vancouver, BC, Canada D Louis-Philippe Boulet, MD Neil Barnes, MD Hôpital Laval London Chest Hospital O Sainte-Foy , Quebec, Canada London, England, UK R Alvaro A. Cruz, MD Peter J. Barnes, MD EP Federal University of Bahia National Heart and Lung Institute School of Medicine London, England, UK Salvador, Brazil R Eric D. Bateman, MD Mark FitzGerald, MD University Cape Town Lung Institute R University of British Columbia Cape Town, South Africa Vancouver, BC, Canada O Allan Becker, MD Tari Haahtela, MD University of Manitoba R Helsinki University Central Hospital Winnipeg, Manitoba, Canada Helsinki, Finland TE Jeffrey M. Drazen, MD Mark L. Levy, MD Harvard Medical School AL University of Edinburgh Boston, Massachusetts, USA London England, UK Robert F. Lemanske, Jr., M.D. Paul O'Byrne, MD University of Wisconsin T McMaster University School of Medicine O Ontario, Canada Madison, Wisconsin, USA N Ken Ohta, MD, PhD Paul O'Byrne, MD Teikyo University School of Medicine McMaster University O Tokyo, Japan Ontario, Canada -D Pierluigi Paggiaro, MD Ken Ohta, MD, PhD University of Pisa Teikyo University School of Medicine Pisa, Italy Tokyo, Japan L IA Soren Erik Pedersen, M.D. Soren Erik Pedersen, M.D. Kolding Hospital Kolding Hospital R Kolding, Denmark Kolding, Denmark E Manuel Soto-Quiroz, MD Emilio Pizzichini, MD Hospital Nacional de Niños Universidade Federal de Santa Catarina AT San José, Costa Rica Florianópolis, SC, Brazil M Gary W. Wong, MD Helen K. Reddel, MD Chinese University of Hong Kong Woolcock Institute of Medical Research Hong Kong ROC Camperdown, NSW, Australia D TE Sean D. Sullivan, PhD Professor of Pharmacy, Public Health University of Washington H Seattle, Washington, USA IG Sally E. Wenzel, M.D. University of Pittsburgh R Pittsburgh, Pennsylvania, USA PY Heather J. Zar, MD University of Cape Town Cape Town, South Africa O C *Disclosures for members of GINA Executive and Science Committees can be found at: i http://www.ginasthma.com/Committees.asp?l1=7&l2=2
  • 4. PREFACE Asthma is a serious global health problem. People of all In spite of these dissemination efforts, international E ages in countries throughout the world are affected by this surveys provide direct evidence for suboptimal asthma C chronic airway disorder that, when uncontrolled, can place control in many countries, despite the availability of severe limits on daily life and is sometimes fatal. The effective therapies. It is clear that if recommendations U prevalence of asthma is increasing in most countries, contained within this report are to improve care of people D especially among children. Asthma is a significant burden, with asthma, every effort must be made to encourage O not only in terms of health care costs but also of lost health care leaders to assure availability of and access to R productivity and reduced participation in family life. medications, and develop means to implement effective EP asthma management programs including the use of During the past two decades, we have witnessed many appropriate tools to measure success. scientific advances that have improved our understanding R of asthma and our ability to manage and control it In 2002, the GINA Report stated that “it is reasonable to effectively. However, the diversity of national health care R expect that in most patients with asthma, control of the service systems and variations in the availability of asthma disease can, and should be achieved and maintained.” O therapies require that recommendations for asthma care To meet this challenge, in 2005, Executive Committee be adapted to local conditions throughout the global R recommended preparation of a new report not only to community. In addition, public health officials require incorporate updated scientific information but to implement TE information about the costs of asthma care, how to an approach to asthma management based on asthma effectively manage this chronic disorder, and education control, rather than asthma severity. Recommendations to AL methods to develop asthma care services and programs assess, treat and maintain asthma control are provided in responsive to the particular needs and circumstances this document. The methods used to prepare this within their countries. T document are described in the Introduction. O In 1993, the National Heart, Lung, and Blood Institute It is a privilege for me to acknowledge the work of the N collaborated with the World Health Organization to many people who participated in this update project, as convene a workshop that led to a Workshop Report: O well as to acknowledge the superlative work of all who Global Strategy for Asthma Management and Prevention. have contributed to the success of the GINA program. -D This presented a comprehensive plan to manage asthma with the goal of reducing chronic disability and premature The GINA program has been conducted through deaths while allowing patients with asthma to lead L unrestricted educational grants from AstraZeneca, productive and fulfilling lives. IA Boehringer Ingelheim, Chiesi Group, Cipla, GlaxoSmithKline, Meda Pharma, Merck Sharp & Dohme, R At the same time, the Global Initiative for Asthma (GINA) Mitsubishi Tanabe Pharma, Novartis, Nycomed and was implemented to develop a network of individuals, E PharmAxis. The generous contributions of these organizations, and public health officials to disseminate AT companies assured that Committee members could meet information about the care of patients with asthma while at together to discuss issues and reach consensus in a the same time assuring a mechanism to incorporate the M constructive and timely manner. The members of the results of scientific investigations into asthma care. Publications based on the GINA Report were prepared GINA Committees are, however, solely responsible for the D and have been translated into languages to promote statements and conclusions presented in this publication. TE international collaboration and dissemination of information. To disseminate information about asthma GINA publications are available through the Internet H care, a GINA Assembly was initiated, comprised of asthma (http://www.ginasthma.org). IG care experts from many countries to conduct workshops with local doctors and national opinion leaders and to hold R seminars at national and international meetings. In PY addition, GINA initiated an annual World Asthma Day (in 2001) which has gained increasing attention each year to Eric Bateman, MD O raise awareness about the burden of asthma, and to initiate activities at the local/national level to educate Chair, GINA Executive Committee C families and health care professionals about effective University of CapeTown Lung Institute methods to manage and control asthma. Cape Town, South Africa ii
  • 5. GLOBAL STRATEGY FOR ASTHMA MANAGEMENT AND PREVENTION Table of Contents PREFACE .........................................................................ii CLINICAL DIAGNOSIS...................................................16 E Medical History...........................................................16 C METHODOLOGY AND SUMMARY OF NEW Symptoms ..............................................................16 U RECOMMENDATION, 2007 UPDATE .........................vi Cough variant asthma ............................................16 D Exercise-Induced bronchospasm ...........................17 INTRODUCTION ..............................................................x Physical Examination .................................................17 O Tests for Diagnosis and Monitoring ............................17 R CHAPTER 1. DEFINITION AND OVERVIEW..................1 Measurements of lung function...............................17 EP Spirometry ..............................................................18 KEY POINTS ....................................................................2 Peak expiratory flow ...............................................18 R Measurement of airway responsiveness.................19 DEFINITION .....................................................................2 Non-Invasive markers of airway inflammation ........19 R Measurements of allergic status .............................19 O THE BURDEN OF ASTHMA.............................................3 Prevalence, Morbidity and Mortality .............................3 DIAGNOSTIC CHALLENGES AND R Social and Economic Burden .......................................3 DIFFERENTIAL DIAGNOSIS.......................................20 TE Children 5 Years and Younger ...................................20 FACTORS INFLUENCING THE DEVELOPMENT AND Older Children and Adults ..........................................20 EXPRESSION OF ASTHMA..........................................4 AL The Elderly .................................................................21 Host Factors................................................................4 Occupational Asthma .................................................21 Genetic.....................................................................4 T Distinguishing Asthma from COPD ............................21 Obesity .....................................................................5 O Sex ...........................................................................5 CLASSIFICATION OF ASTHMA.....................................22 Environmental Factors ................................................5 N Allergens ..................................................................5 Etiology ......................................................................22 Phenotype..................................................................22 O Infections ..................................................................5 Occupational sensitizers...........................................5 Asthma Control ..........................................................22 -D Tobacco smoke ........................................................6 Asthma Severity .........................................................23 Outdoor/Indoor air pollution ......................................6 REFERENCES ...............................................................23 L Diet...........................................................................7 IA MECHANISMS OF ASTHMA............................................7 CHAPTER 3. ASTHMA MEDICATIONS ........................27 R Airway Inflammation In Asthma ....................................7 E Inflammatory cells ....................................................7 KEY POINTS ..................................................................28 AT Inflammatory mediators ............................................7 Structural changes in the airways .............................8 INTRODUCTION ............................................................28 M Pathophysiology...........................................................8 Airway hyperresponsiveness....................................8 ASTHMA MEDICATIONS: ADULTS ...............................28 D Special Mechanisms ....................................................8 Route of Administration ..............................................28 Acute exacerbations .................................................8 Controller Medications................................................29 TE Nocturnal asthma .....................................................9 Inhaled glucocorticosteroids ...................................29 Irreversible airflow limitation .....................................9 Leukotriene modifiers .............................................30 H Difficult-to-treat asthma ............................................9 Long-acting inhaled 2-agonists .............................30 IG Smoking and asthma................................................9 Theophylline ...........................................................31 Cromones: sodium cromoglycate and R REFERENCES .................................................................9 nedocromil sodium........................................31 PY Long-acting oral 2-agonists...................................32 CHAPTER 2. DIAGNOSIS AND CLASSIFICATION .....15 Anti-IgE ..................................................................32 O Systemic glucocorticosteroids ................................32 KEY POINTS ..................................................................16 C Oral anti-allergic compounds ..................................32 INTRODUCTION ............................................................16 Other controller therapies .......................................32 Allergen-specific immunotherapy............................33 iii
  • 6. Reliever Medications ...................................................34 Rapid-acting inhaled 2-agonists............................34 ASTHMA PREVENTION.................................................54 Systemic glucocorticosteroids ................................34 Anticholinergics ......................................................34 PREVENTION OF ASTHMA SYMPTOMS AND E Theophylline ...........................................................35 EXACERBATIONS....................................................55 Short-acting oral 2-agonists..................................35 C Indoor Allergens .......................................................55 Complementary and Alternative Medicine ...................35 Domestic mites.......................................................55 U Furred animals .......................................................55 D ASTHMA TREATMENT: CHILDREN .............................35 Cockroaches ..........................................................55 O Route of Administration ..............................................35 Fungi ......................................................................56 R Controller Medications................................................36 Outdoor Allergens ......................................................56 Inhaled glucocorticosteroids ...................................36 Indoor Air Pollutants ..................................................56 EP Leukotriene modifiers .............................................38 Outdoor Air Pollutants ................................................56 Long-acting inhaled 2-agonists .............................38 Occupational Exposures ............................................56 R Theophylline ...........................................................39 Food and Food Additives ...........................................56 Cromones: sodium cromoglycate and nedocromil R Drugs .........................................................................57 sodium .........................................................39 Influenza Vaccination .................................................57 O Long-acting oral 2-agonists...................................39 Obesity.......................................................................57 R Systemic glucocorticosteroids ................................39 Emotional Stress ........................................................57 Reliever Medications ...................................................40 Other Factors That May Exacerbate Asthma .............57 TE Rapid-acting inhaled 2-agonists and short-acting oral 2-agonists ..............................................40 COMPONENT 3: ASSESS, TREAT AND MONITOR AL Anticholinergics ......................................................40 ASTHMA......................................................................57 REFERENCES ...............................................................40 T KEY POINTS ..................................................................57 O CHAPTER 4. ASTHMA MANAGEMENT AND N INTRODUCTION ............................................................57 PREVENTION ................................................................49 O ASSESSING ASTHMA CONTROL.................................58 INTRODUCTION ............................................................50 -D TREATING TO ACHIEVE CONTROL.............................58 COMPONENT 1: DEVELOP PATIENT/ Treatment Steps for Achieving Control........................58 L DOCTOR PARTNERSHIP...........................................50 Step 1: As-needed reliever medication ..................58 IA Step 2: Reliever medication plus a single KEY POINTS ..................................................................50 controller .........................................................60 R Step 3: Reliever medication plus one or two E INTRODUCTION ............................................................50 controllers .......................................................60 AT Step 4: Reliever medication plus two or more ASTHMA EDUCATION...................................................51 controllers .......................................................61 M At the Initial Consultation...........................................52 Step 5: Reliever medication plus additional Personal Asthma Action Plans ..................................52 controller options ............................................61 D Follow-up and Review ...............................................52 TE Improving Adherence ................................................52 MONITORING TO MAINTAIN CONTROL ......................61 Self-Management in Children ....................................52 Duration and Adjustments to Treatment ......................61 H Stepping Down Treatment When Asthma Is IG THE EDUCATION OF OTHERS.....................................53 Controlled.................................................................62 Stepping Up Treatment In Response To Loss Of R COMPONENT 2: IDENTIFY AND REDUCE EXPOSURE Control .....................................................................62 PY TO RISK FACTORS ....................................................54 Difficult-to-Treat-Asthma .............................................63 O KEY POINTS ..................................................................54 COMPONENT 4 - MANAGE ASTHMA C INTRODUCTION ............................................................54 EXACERBATIONS ......................................................64 iv
  • 7. Utilization and Cost of Health Care Resources.........89 KEY POINTS ..................................................................64 Determining the Economic Value of Interventions in Asthma ...................................................................90 INTRODUCTION ............................................................64 E GINA DISSEMINATION/IMPLEMENTATION C ASSESSMENT OF SEVERITY.......................................65 RESOURCES ............................................................90 U MANAGEMENT–COMMUNITY SETTINGS ...................65 REFERENCES ...............................................................91 D Treatment...................................................................66 O Bronchodilators ......................................................66 R Glucocorticosteroids ...............................................66 EP MANAGEMENT–ACUTE CARE SETTINGS ..................66 Assessment ................................................................66 R Treatment....................................................................68 R Oxygen...................................................................68 Rapid-acting inhaled 2–agonists...........................68 O Epinephrine ............................................................68 R Additional bronchodilators ...........................................68 TE Systemic glucocorticosteroids ................................68 Inhaled glucocorticosteroids ...................................69 Magnesium.............................................................69 AL Helium oxygen therapy...........................................69 Leukotriene modifiers .............................................69 T Sedatives ...............................................................69 O Criteria for Discharge from the Emergency N Department vs. Hospitalization.................................69 O COMPONENT 5. SPECIAL CONSIDERATIONS ..........70 -D Pregnancy.....................................................................70 Surgery .........................................................................70 Rhinitis, Sinusitis, And Nasal Polyps .............................71 L Rhinitis ...................................................................71 IA Sinusitis ..................................................................71 R Nasal polyps...........................................................71 Occupational Asthma ....................................................71 E Respiratory Infections ...................................................72 AT Gastroesophageal Reflux..............................................72 Aspirin-Induced Asthma ................................................72 M Anaphylaxis and Asthma...............................................73 D REFERENCES ...............................................................73 TE CHAPTER 5. IMPLEMENTATION OF ASTHMA H GUIDELINES IN HEALTH SYSTEMS .........................87 IG KEY POINTS ..................................................................88 R PY INTRODUCTION ............................................................88 O GUIDELINE IMPLEMENTATION STRATEGIES ............88 ECONOMIC VALUE OF INTERVENTIONS AND C GUIDELINE IMPLEMENTATION IN ASTHMA...........89 v
  • 8. METHODOLOGY AND SUMMARY OF NEW RECOMMENDATIONS GLOBAL STRATEGY FOR E ASTHMA MANAGEMENT AND PREVENTION: 2009 C U UPDATE* D O When the Global Initiative for Asthma (GINA) program was discuss each publication that was felt would have an initiated in 1993, the primary goal was to produce impact on asthma management and prevention by at least R recommendations for asthma management based on the 1 member of the Committee, and to reach a consensus on EP best scientific information available. Its first report, the changes in the report. In the absence of consensus NHLBI/WHO Workshop Report: Global Strategy for disagreements were decided by an open vote of the full R Asthma Management and Prevention was issued in 1995 committee. and revised in 2002 and 2006. These reports, and their R companion documents, have been widely distributed and Summary of Recommendations in the 2009 Update: O translated into many languages. The 2006 report was Between July 1, 2008 and June 30, 2009, 392 articles met based on research published through June, 2006 and can the search criteria; 10 additional publications were brought R be found on the GINA website (www.ginasthma.org). to the attention of the committee. Of the 402 articles, 23 TE papers were identified as having an impact on the GINA The GINA Science Committee was established in 2002 to Report (updated 2009) that was posted on the website in review published research on asthma management and December 2009 either by: 1) confirming, that is, adding to AL prevention, to evaluate the impact of this research on or replacing an existing reference, or 2) modifying, that is, recommendations in the GINA documents related to changing the text or introducing a concept requiring a new management and prevention, and to post yearly updates Trecommendation to the report. The summary is reported O on the GINA website. The first update of the 2006 report in three segments: A) Modifications in the text; B) (2007 update) included the impact of publications from References that provided confirmation or an update of N July 1, 2006 through June 30, 2007; the 2008 updated previous recommendations; and C) Changes or O included the impact of publications from July 1, 2007 modifications to the text. through June 30, 2008. This 2009 update includes the -D impact of publications from July 1, 2008 through June 30, Asthma in Children 5 Years and Younger: In 2008, a 2009. number of pediatric experts developed a report which L focused on asthma care in children 5 years and younger. IA Methods: The methodology used to produce this 2009 The Global Strategy for Asthma Management and update included a Pub Med search using search fields Prevention in Children 5 Years and Younger was released R established by the Committee: 1) asthma, All Fields, All in early 2009 (can be found on www.ginasthma.org). E ages, only items with abstracts, Clinical Trial, Human, Accordingly, the Executive Summary “Managing Asthma in AT sorted by Authors; and 2) asthma AND systematic, All Children 5 Years and Younger” that appeared on pages fields, ALL ages, only items with abstracts, Human, sorted xiv – xvii is deleted – see section C. by author. In addition, publications in peer review journals M not captured by Pub Med could be submitted to individual Asthma Control: In review of the published literature, the D members of the Committee providing an abstract and the Committee determined that many changes were required full paper were submitted in (or translated into) English. in the segment “Classification of Asthma.” Accordingly, a TE new segment appears beginning on page 22 – see section All members of the Committee received a summary of D.1). H citations and all abstracts. Each abstract was assigned to IG at least two Committee members, although all members Evidence Reviews: In the preparation of GINA reports, were offered the opportunity to provide an opinion on any including this 2009 update, levels of evidence has been R abstract. Members evaluated the abstract or, up to her/his completed using four categories as described on page xiii. PY judgment, the full publication, by answering specific written The committee has had extensive discussions internally, questions from a short questionnaire, and to indicate if the as well as with proponents of a new methodology for scientific data presented impacted on recommendations in describing recommendations (the GRADE system). The O the GINA report. If so, the member was asked to implications for the widespread adaptation of this system C specifically identify modifications that should be made. The has been explored by the Committee with regard to entire GINA Science Committee met twice yearly to resource implications, especially given the already vi * The Global Strategy for Asthma Management and Prevention (updated 2009), the updated Pocket Guides and the complete list of references examined by the Committee are available on the GINA website www.ginasthma.org. † Members (2008-2009): M. FitzGerald, Chair; P. Barnes, N. Barnes, E. Bateman, A. Becker, J. Drazen, R. Lemanske, P. O’Byrne, K. Ohta, S. Pedersen, E. Pizzichini, H. Reddel, S. Sullivan, S. Wenzel, H. Zar.
  • 9. rigorous method of reviewing the literature and updating AS, Buist AS, et al. Asthma drug use and the recommendations that is currently in place. The development of Churg-Strauss syndrome (CSS). committee has decided that it would be inappropriate to Pharmcoepidemiology and Drug Safety. 2007;16:620-26. implement this methodology for all the recommendations E within GINA and recommended instead to use the method- Pg 31, left column, paragraph 1, insert: …does not C ology, selectively, especially where the balance between increase the risk of asthma-related hospitalizations214 … U efficacy and cost effectiveness is unclear or where there is Reference 214. Jaeschke R, O'Byrne PM, Mejza F, Nair controversy with regard to the recommendation. The P, Lesniak W, Brozek J, Thabane L, Cheng J, D Committee applied GRADE to two questions (see section Schünemann HJ, Sears MR, Guyatt G. The safety of long- O D.2) and will continue to explore the use of GRADE-like acting beta-agonists among patients with asthma using R methodology for issues that require more in-depth inhaled corticosteroids: systematic review and EP evaluation. metaanalysis. Am J Respir Crit Care Med. 2008 Nov 15;178(10):1009-16. Epub 2008 Sep 5. A. Modifications in the text: R Pg 34, left column, end of paragraph 1, insert: Data on a R Pg 19, right column, insert end of first paragraph: although human monoclonal antibody against tumor necrosis factor it has been shown that the use of FeNo as a measure of (TNF)-alpha suggest that the risk benefit equation does O asthma control does not improve control or enable not favor the use of this class of treatments in severe R reduction in dose of inhaled glucocorticosteroid55. asthma216. Reference 216. Wenzel SE, Barnes PJ, Reference 55. Szefler SJ, Mitchell H, Sorkness CA, Bleecker ER, Bousquet J, Busse W, Dahlén SE, et al; T03 TE Gergen PJ, O'Connor GT, Morgan WJ, et al. Management Asthma Investigators. A randomized, double-blind, of asthma based on exhaled nitric oxide in addition to placebo-controlled study of tumor necrosis factor-alpha AL guideline-based treatment for inner-city adolescents and blockade in severe persistent asthma. Am J Respir Crit young adults: a randomised controlled trial. Lancet. 2008 Care Med. 2009 Apr 1;179(7):549-58. Epub 2009 Jan 8. Sep 20;372(9643):1065-72. T Pg 35, right column, beginning of paragraph 4, insert: O Pg 30, left column, line 6, insert: although there appear to Dietary supplements, including selenium therapy197 are not N be differences in response according to of proven benefit and the use of a low sodium diet as an symptom/inflammation phenotype212. Reference 212. adjunctive therapy to normal treatment has no additional O Haldar P, Pavord ID, Shaw DE, Berry MA, Thomas M, therapeutic benefit in adults with asthma. In addition it has -D Brightling CE, Wardlaw AJ, Green RH. Cluster analysis no effect on bronchial reactivity to methacholine217. and clinical asthma phenotypes. Am J Respir Crit Care Reference 217. Pogson ZE, Antoniak MD, Pacey SJ, Med. 2008 Aug 1;178(3):218-24. Epub 2008 May 14 Lewis SA, Britton JR, Fogarty AW. Does a low sodium L diet improve asthma control? A randomized controlled trial. IA Pg 30, left column, line 11 from end, insert: A meta- Am J Respir Crit Care Med. 2008 Jul 15;178(2):132-8. R analysis of case-control studies of non-vertebral fractures Epub 2008 May 1. in adults using inhaled glucocorticosteroids (BDP or E equivalent) indicated that in older adults, the relative risk of Pg 38, Figure 3.6, delete last statement and insert: AT non-vertebral fractures increases by about 12% for each Inhaled glucocorticosteroid use has the potential for 1000 µg/day increase in the dose BDP or equivalent but reducing bone mineral accretion in male children M that the magnitude of this risk was considerably less than progressing through puberty, but this risk is likely to be out- other common risk factors for fracture in the older weighed by the ability to reduce the amount of oral D adult213. Reference 213. Weatherall M, James K, Clay corticosteroids used in these children218. Reference 218. TE J, Perrin K, Masoli M, Wijesinghe M, Beasley R. Dose- Kelly HW, Van Natta ML, Covar RA, Tonascia J, Green response relationship for risk of non-vertebral fracture with RP, Strunk RC; CAMP Research Group. Effect of long- H inhaled corticosteroids. Clin Exp Allergy. 2008 term corticosteroid use on bone mineral density in IG Sep;38(9):1451-8. Epub 2008 Jun 3. children: a prospective longitudinal assessment in the childhood Asthma Management Program (CAMP) study. R Pg 30, right column, last paragraph delete last sentence Pediatrics. 2008 Jul;122(1):e53-61. and references 52-54 and replace with: No association PY was found between Churg-Strauss syndrome and Pg 39, left column, end of first paragraph, insert: leukotriene modifiers, after controlling for asthma drug use, Montelukast has not been demonstrated to be an effective O although it is not possible to rule out modest associations inhaled glucocorticosteroid sparing alternative in children C given that Churg-Strauss syndrome is so rare and so with moderate-to-severe persistent asthma219. Reference highly correlated with asthma severity52. New Reference 219. Strunk RC, Bacharier LB, Phillips BR, Szefler SJ, 52. Harrold LR, Patterson K, Andrade SE, Dube T, Go Zeiger RS, Chinchilli VM, et al.; CARE Network. vii
  • 10. Azithromycin or montelukast as inhaled corticosteroid- blockers, within 24 hours of hospital admission, for an sparing agents in moderate-to-severe childhood asthma acute coronary event, have lower in-hospital mortality study. J Allergy Clin Immunol. 2008 Dec;122(6):1138- rates366, 367. Reference 366. Babu KS, Gadzik F, Holgate 1144.e4. Epub 2008 Oct 25. ST. Absence of respiratory effects with ivabradine in E patients with asthma. Br J Clin Pharmacol. 2008 C Pg 51, right column, end of last paragraph, insert: Lay Jul;66(1):96-101. Epub 2008 Mar 13. Reference 367. U educators can be recruited and trained to deliver a discrete Olenchock BA, Fonarow GG, Pan W, Hernandez A, D area of respiratory care (for example, asthma self- Cannon CP; Get With The Guidelines Steering Committee. management education) with comparable outcomes to Current use of beta blockers in patients with reactive O those achieved by primary care based practice nurses362 airway disease who are hospitalized with acute coronary R (Evidence B). syndromes. Am J Cardiol. 2009 Feb 1;103(3):295-300. EP Reference 362. Partridge MR, Caress AL, Brown C, Epub 2008 Nov 19. Hennings J, Luker K, Woodcock A, Campbell M. Can lay people deliver asthma self-management education as Pg 62, left column, last paragraph, delete sentence and R effectively as primary care based practice nurses? replace with: However, this is more likely to lead to loss of R Thorax. 2008 Sep;63(9):778-83. Epub 2008 Feb 15.) asthma control137, 368 (Evidence B). Reference 368: Godard P, Greillier P, Pigearias B, Nachbaur G, O Pg 52, right column, last paragraph, delete first sentence Desfougeres JL, Attali V. Maintaining asthma control in R and replace with: Although interventions for enhancing persistent asthma: comparison of three strategies in a 6- medication adherence have been developed363, studies of month double-blind randomised study. Respir Med. 2008 TE adults and children with asthma34 have shown that around Aug;102(8):1124-31. Epub 2008 Jul 7. 50% of those on long-term therapy fail to take medications AL as directed at least part of the time. Reference 363. Pg 72, left column, end of third paragraph, insert: Adults Haynes RB, Ackloo E, Sahota N, McDonald HP, Yao X. with asthma may be at increased risk of serious Interventions for enhancing medication adherence. T pneumococcal disease370. Reference 370. Juhn YJ, Kita O Cochrane Database Syst Rev. 2008 Apr 16;(2):CD000011 H, Yawn BP, Boyce TG, Yoo KH, McGree ME, Weaver AL, Wollan P, Jacobson RM. Increased risk of serious N Pg 55, left column, end of first paragraph, insert: Patients pneumococcal disease in patients with asthma. J Allergy with well-controlled asthma are less likely to experience Clin Immunol. 2008 Oct;122(4):719-23. Epub 2008 Sep O exacerbations than those whose asthma is not well- 13. -D controlled364. Reference 364: Bateman ED, Bousquet J, Busse WW, Pg 89, right column, first paragraph, insert: Use of Clark TJ, Gul N, Gibbs M, Pedersen S; GOAL Steering administrative datasets (e.g., dispensing records) or urgent L Committee and Investigators. Stability of asthma control health care utilization can help to identify at-risk patients or IA with regular treatment: an analysis of the Gaining Optimal to audit the quality of health care23. Reference 23. R Asthma controL (GOAL) study. Allergy. 2008 Bereznicki BJ, Peterson GM, Jackson SL, Walters EH, E Jul;63(7):932-8. Fitzmaurice KD, Gee PR. Data-mining of medication records to improve asthma management. Med J Aust. AT Pg 56, left column, end of third paragraph delete as 2008 Jul 7;189(1):21-5. indicated and insert: Installation of non-polluting, more M effective heating (heat pump, wood pellet burner, flued B. References that provided confirmation or update of gas) in the homes of children with asthma does not previous recommendations: D significantly improve lung function but does significantly TE reduce symptoms of asthma, days off school, healthcare Pg 24: Right column, replace reference 32. Horvath I, utilization, and visits to a pharmacist365. Hunt J, Barnes PJ, Alving K, Antczak A, Baraldi E, et al. H Reference 365. Howden-Chapman P, Pierse N, Nicholls Exhaled breath condensate: methodological recommendations and unresolved questions. Eur Respir J IG S, Gillespie-Bennett J, Viggers H, Cunningham M, et al. Effects of improved home heating on asthma in community 2005;26:523-48. R dwelling children: randomized controlled trial. BMJ. 2008 Pg 30: Left column, insert reference 211. O'Byrne PM, PY Sep 23;337:a1411. doi: 10.1136/bmj.a1411. Naya IP, Kallen A, Postma DS, Barnes PJ. Increasing Pg 57, left column, end of first paragraph, insert: Beta doses of inhaled corticosteroids compared to adding long- O blockers have a proven benefit in the management of acting inhaled beta2-agonists in achieving asthma control. C patients with acute coronary syndromes and for secondary Chest. 2008 Dec;134(6):1192-9. Epub 2008 Aug 8. prevention of coronary events. Data suggest that patients with asthma who receive newer more cardio-selective beta viii
  • 11. Pg 31: right column, insert reference 215. Cates CJ, Asthma Management and Prevention in Children 5 Years Cates MJ. Regular treatment with salmeterol for chronic and Younger. Available at www.ginasthma.org asthma: serious adverse events. Cochrane Database of Systematic Reviews 2008, Issue 3. Art. No.: CD006363 Pg 61, right column, second paragraph: Change Evidence E A to Evidence B. C Pg 70, right column, second paragraph, insert reference U 369. Tata LJ, Lewis SA, McKeever TM, Smith CJ, Doyle Pg 70, right column, second paragraph, first phrase delete P, Smeeth L, Gibson JE, Hubbard RB. Effect of maternal and replace with: Although there is a general concern D asthma, exacerbations and asthma medication use on about the use of any medication in pregnancy,…. O congenital malformations in offspring: a UK population- R based study. Thorax. 2008 Nov;63(11):981-7. Epub 2008 D. Committee recommended changes: EP Aug 4. 1. Asthma Control: Based on a number of recent Pg 70, right column, second paragraph, replace reference publications, the Committee recommended significant R 268. Bakhireva LN, Schatz M, Jones KL, Chambers CD; changes to the section on Classification of Asthma, pages Organization of Teratology Information Specialists 22 – 23. Figure 2-4 has been deleted. Former Figure 2-5 R Collaborative Research Group. Asthma control during (now appears as Figure 2-4), has been modified. This O pregnancy and the risk of preterm delivery or impaired modified Figure also appears on page 58 (as Figure 4.3- fetal growth. Ann Allergy Asthma Immunol. 2008 1). R Aug;101(2):137-43 TE 2. Grading Evidence: The GINA Science Committee is Pg 71, left column, third paragraph, replace reference 279. developing a system to identify recommendations where AL Shaaban R, Zureik M, Soussan D, Neukirch C, Heinrich J, there maybe controversy or debate between efficacy and Sunyer J, et al. Rhinitis and onset of asthma: a cost. In addition there are some recommendations that longitudinal population-based study. Lancet. 2008 Sep have a less robust evidence base. In this context we see a T 20;372(9643):1049-57. possible role for the GRADE methodology providing a O framework collate the evidence and create evidence N Pg 78, delete reference 150. tables. To assess the feasibility of this approach two questions were reviewed in 2009 to begin the work: O C. Changes or modifications to the text. -D a. In adults with asthma, does monoclonal anti-IgE, Pg xiv – xvii: Delete section Executive Summary: omalizumab, compared to placebo improve patient out- Managing Asthma in Children 5 Years and Younger. This comes? L has been replaced with new report Global Strategy for IA Asthma Management and Prevention in Children 5 Years b. In adults with acute exacerbations of asthma, does and Younger. intravenous magnesium sulphate compared to placebo R improve patient important outcomes? E Pg 28, left column line 10, delete: and other systemic AT steroid-sparing therapies. Evidence tables were produced and are being evaluated and the results from this work are being prepared for Pg 29, Figure 3-1: Change Fluticasone to Fluticasone publication. Further information will be provided in the M propionate. 2010 update. D Pg 31, left column, end of paragraph 2, insert: See TE Appendix B, GINA Pocket Guide updated 2009 for information on Asthma Combination Medications For H Adults and Children 5 Years and Older. IG Pg 31, left column, beginning of paragraph 3, insert: R …when used as a combination medication with inhaled PY glucocorticosteroids… Pg 37, Figure 3-4: Change Fluticasone to Fluticasone O propionate. C Pg 59, Figure 4.3-2: Modifications to clarify wording on Figure; modify lower segment to read Global Strategy for ix
  • 12. INTRODUCTION Asthma is a serious public health problem throughout the aim to enhance communication with asthma specialists, E world, affecting people of all ages. When uncontrolled, primary-care health professionals, other health care C asthma can place severe limits on daily life, and is workers, and patient support organizations. The Executive sometimes fatal. Committee continues to examine barriers to implementation U of the asthma management recommendations, especially D In 1993, the Global Initiative for Asthma (GINA) was the challenges that arise in primary-care settings and in O formed. Its goals and objectives were described in a 1995 developing countries. R NHLBI/WHO Workshop Report, Global Strategy for EP Asthma Management and Prevention. This Report While early diagnosis of asthma and implementation of (revised in 2002), and its companion documents, have appropriate therapy significantly reduce the socioeconomic been widely distributed and translated into many burdens of asthma and enhance patients’ quality of life, R languages. A network of individuals and organizations medications continue to be the major component of the R interested in asthma care has been created and several cost of asthma treatment. For this reason, the pricing of country-specific asthma management programs have asthma medications continues to be a topic for urgent O been initiated. Yet much work is still required to reduce need and a growing area of research interest, as this has R morbidity and mortality from this chronic disease. important implications for the overall costs of asthma TE management. In January 2004, the GINA Executive Committee recommended that the Global Strategy for Asthma Moreover, a large segment of the world’s population lives AL Management and Prevention be revised to emphasize in areas with inadequate medical facilities and meager asthma management based on clinical control, rather than financial resources. The GINA Executive Committee T classification of the patient by severity. This important recognizes that “fixed” international guidelines and “rigid” O paradigm shift for asthma care reflects the progress that scientific protocols will not work in many locations. Thus, N has been made in pharmacologic care of patients. Many the recommendations found in this Report must be asthma patients are receiving, or have received, some adapted to fit local practices and the availability of health O asthma medications. The role of the health care care resources. -D professional is to establish each patient’s current level of treatment and control, then adjust treatment to gain and As the GINA Committees expand their work, every effort maintain control. This means that asthma patients should will be made to interact with patient and physician groups L experience no or minimal symptoms (including at night), at national, district, and local levels, and in multiple health IA have no limitations on their activities (including physical care settings, to continuously examine new and innovative R exercise), have no (or minimal) requirement for rescue approaches that will ensure the delivery of the best asthma medications, have near normal lung function, and care possible. GINA is a partner organization in a program E experience only very infrequent exacerbations. launched in March 2006 by the World Health Organization, AT the Global Alliance Against Chronic Respiratory Diseases FUTURE CHALLENGES (GARD). Through the work of the GINA Committees, and M in cooperation with GARD initiatives, progress toward In spite of laudable efforts to improve asthma care over the better care for all patients with asthma should be D past decade, a majority of patients have not benefited from substantial in the next decade. TE advances in asthma treatment and many lack even the rudiments of care. A challenge for the next several years METHODOLOGY H is to work with primary health care providers and public IG health officials in various countries to design, implement, A. Preparation of yearly updates: Immediately and evaluate asthma care programs to meet local needs. following the release of an updated GINA Report in 2002, R The GINA Executive Committee recognizes that this is a the Executive Committee appointed a GINA Science PY difficult task and, to aid in this work, has formed several Committee, charged with keeping the Report up-to-date groups of global experts, including: a Dissemination Task by reviewing published research on asthma management O Group; the GINA Assembly, a network of individuals who and prevention, evaluating the impact of this research on care for asthma patients in many different health care the management and prevention recommendations in the C settings; and regional programs (the first two being GINA GINA documents, and posting yearly updates of these Mesoamerica and GINA Mediterranean). These efforts documents on the GINA website. The first update was x
  • 13. posted in October 2003, based on publications from as possible, while at the same time recognizing that one of January 2000 through December 2002. A second update the values of the GINA Report has been to provide appeared in October 2004, and a third in October 2005, background information about asthma management and each including the impact of publications from January the scientific information on which management E through December of the previous year. recommendations are based. C U The process of producing the yearly updates began with a In January 2006, the Committee met again for a two-day D Pub Med search using search fields established by the session during which another in-depth evaluation of each O Committee: 1) asthma, All Fields, All ages, only items with chapter was conducted. At this meeting, members abstracts, Clinical Trial, Human, sorted by Authors; and reviewed the literature that appeared in 2005—using the R 2) asthma AND systematic, All fields, ALL ages, only items same criteria developed for the update process. The list EP with abstracts, Human, sorted by Author. In addition, of 285 publications from 2005 that were considered is peer-reviewed publications not captured by Pub Med could posted on the GINA website. At the January meeting, it R be submitted to individual members of the Committee was clear that work remaining would permit the report to providing an abstract and the full paper were submitted in be finished during the summer of 2006 and, accordingly, R (or translated into) English. the Committee requested that as publications appeared O throughout early 2006, they be reviewed carefully for their All members of the Committee received a summary of impact on the recommendations. At the Committee’s next R citations and all abstracts. Each abstract was assigned to meeting in May, 2006 publications meeting the search TE two Committee members, and an opportunity to provide an criteria were considered and incorporated into the current opinion on any single abstract was offered to all members. drafts of the chapters, where appropriate. A final meeting AL Members evaluated the abstract or, up to her/his of the Committee was held in September 2006, at which judgment, the full publication, by answering specific written publications that appear prior to July 31, 2006 were questions from a short questionnaire, indicating whether T considered for their impact on the document. O the scientific data presented affected recommendations in the GINA Report. If so, the member was asked to Periodically throughout the preparation of this report, N specifically identify modifications that should be made. representatives from the GINA Science Committee have O The entire GINA Science Committee met on a regular met with members of the GINA Assembly (May and basis to discuss each individual publication that was September, 2005 and May 2006) to discuss the overall -D judged by at least one member to have an impact on theme of asthma control and issues specific to each of the asthma management and prevention recommendations, chapters. The GINA Assembly includes representatives L and to reach a consensus on the changes in the Report. from over 50 countries and many participated in these IA Disagreements were decided by vote. interim discussions. In addition, members of the Assembly were invited to submit comments on a DRAFT document R The publications that met the search criteria for each during the summer of 2006. Their comments, along with E yearly update (between 250 and 300 articles per year) comments received from several individuals who were AT mainly affected the chapters related to clinical invited to serve as reviewers, were considered by the management. Lists of the publications considered by the Committee in September, 2006. M Science Committee each year, along with the yearly updated reports, are posted on the GINA website, Summary of Major Changes D www.ginasthma.org. TE The major goal of the revision was to present information B. Preparation of new 2006 report: In January 2005, about asthma management in as comprehensive manner H the GINA Science Committee initiated its work on this new as possible but not in the detail that would normally be IG report. During a two-day meeting, the Committee found in a textbook. Every effort has been made to select established that the main theme of the new report should key references, although in many cases, several other R be the control of asthma. A table of contents was publications could be cited. The document is intended to PY developed, themes for each chapter identified, and writing be a resource; other summary reports will be prepared, teams formed. The Committee met in May and September including a Pocket Guide specifically for the care of infants 2005 to evaluate progress and to reach consensus on and young children with asthma. O messages to be provided in each chapter. Throughout its C work, the Committee made a commitment to develop a document that would: reach a global audience, be based on the most current scientific literature, and be as concise xi