Gina - global initiative against asthma

G IN A lobal itiative for sthma

GINA Program Objectives
Increase appreciation of asthma as a global public health problem
Present key recommendations for diagnosis and management of asthma
Provide strategies to adapt recommendations to varying health needs, services, and resources
Identify areas for future investigation of particular significance to the global community

GINA Assembly
A network of individuals participating in the dissemination and implementation of asthma management programs at the local, national and regional level
GINA Assembly members are invited to meet with the GINA Executive Committee during the ATS and ERS meetings

United States United Kingdom Argentina Australia Brazil Austria Canada Chile Belgium China Denmark Colombia Croatia Germany Greece Ireland Italy Syria Hong Kong Japan India Korea Kyrgyzstan Moldova Macedonia Malta Netherlands New Zealand Poland Portugal Georgia Romania Russia Singapore Slovenia Saudi Arabia South Africa Spain Sweden Thailand Switzerland Ukraine Taiwan ROC Venezuela Vietnam Yugoslavia Albania Bangladesh France Mexico Turkey Czech Republic Lebanon Pakistan GINA Assembly Israel Slovakia

GINA Documents
Global Strategy for Asthma Management and Prevention (revised 2006)
Pocket Guide: Asthma Management and Prevention (revised 2006)
Pocket Guide: Asthma Management and Prevention in Children (revised 2006)
Guide for asthma patients and families
All materials are available on GINA web site www.ginasthma.org

Global Strategy for Asthma Management and Prevention
Evidence-based
Implementation oriented
Diagnosis
Management
Prevention
Outcomes can be evaluated

Global Strategy for Asthma Management and Prevention Evidence Category Sources of Evidence A Randomized clinical trials Rich body of data B Randomized clinical trials Limited body of data C Non-randomized trials Observational studies D Panel judgment consensus

Global Strategy for Asthma Management and Prevention (2006)
Definition and Overview
Diagnosis and Classification
Asthma Medications
Asthma Management and Prevention Program
Implementation of Asthma Guidelines in Health Systems
Revised 2006

Definition of Asthma
A chronic inflammatory disorder of the airways
Many cells and cellular elements play a role
Chronic inflammation is associated with airway hyperresponsiveness that leads to recurrent episodes of wheezing, breathlessness, chest tightness, and coughing
Widespread, variable, and often reversible airflow limitation

Source: Peter J. Barnes, MD Asthma Inflammation: Cells and Mediators

Mechanisms: Asthma Inflammation Source: Peter J. Barnes, MD

Source: Peter J. Barnes, MD Asthma Inflammation: Cells and Mediators

Burden of Asthma
Asthma is one of the most common chronic diseases worldwide with an estimated 300 million affected individuals
Prevalence increasing in many countries, especially in children
A major cause of school/work absence

Asthma Prevalence and Mortality Source : Masoli M et al. Allergy 2004

Risk Factors for Asthma
Host factors: predispose individuals to, or protect them from, developing asthma
Environmental factors: influence susceptibility to development of asthma in predisposed individuals, precipitate asthma exacerbations, and/or cause symptoms to persist

Factors that Exacerbate Asthma
Allergens
Respiratory infections
Exercise and hyperventilation
Weather changes
Sulfur dioxide
Food, additives, drugs

Factors that Influence Asthma Development and Expression
Host Factors
Genetic
- Atopy
- Airway hyperresponsiveness
Gender
Obesity
Environmental Factors
Indoor allergens
Outdoor allergens
Occupational sensitizers
Tobacco smoke
Air Pollution
Respiratory Infections
Diet

Is it Asthma?
Recurrent episodes of wheezing
Troublesome cough at night
Cough or wheeze after exercise
Cough, wheeze or chest tightness after exposure to airborne allergens or pollutants
Colds “go to the chest” or take more than 10 days to clear

Asthma Diagnosis
History and patterns of symptoms
Measurements of lung function
- Spirometry
- Peak expiratory flow
Measurement of airway responsiveness
Measurements of allergic status to identify risk factors
Extra measures may be required to diagnose asthma in children 5 years and younger and the elderly

Typical Spirometric (FEV 1 ) Tracings 1 Time (sec) 2 3 4 5 FEV 1 Volume Normal Subject Asthmatic (After Bronchodilator) Asthmatic (Before Bronchodilator) Note: Each FEV 1 curve represents the highest of three repeat measurements

Measuring Variability of Peak Expiratory Flow

Measuring Airway Responsiveness

Intermittent Symptoms less than once a week Brief exacerbations Nocturnal symptoms not more than twice a month • FEV1 or PEF ≥ 80% predicted • PEF or FEV1 variability < 20% Mild Persistent Symptoms more than once a week but less than once a day Exacerbations may affect activity and sleep Nocturnal symptoms more than twice a month • FEV1 or PEF ≥ 80% predicted • PEF or FEV1 variability < 20 – 30%

Moderate Persistent Symptoms daily Exacerbations may affect activity and sleep Nocturnal symptoms more than once a week Daily use of inhaled short-acting 2-agonist • FEV1 or PEF 60-80% predicted • PEF or FEV1 variability > 30% Severe Persistent Symptoms daily Frequent exacerbations Frequent nocturnal asthma symptoms Limitation of physical activities • FEV1 or PEF ≤ 60% predicted • PEF or FEV1 variability > 30%

Levels of Asthma Control 3 or more features of partly controlled asthma present in any week < 80% predicted or personal best (if known) on any day Normal Lung function (PEF or FEV 1 ) One or more / year 1 in any week None Exacerbation More than twice / week None (2 or less / week) Need for rescue / “reliever” treatment Any None Nocturnal symptoms / awakening Any None Limitations of activities More than twice / week None (2 or less / week) Daytime symptoms Uncontrolled Partly controlled (Any present in any week) Controlled (All of the following) Characteristic

1. Develop Patient/Doctor Partnership 2. Identify and Reduce Exposure to Risk Factors 3. Assess, Treat and Monitor Asthma 4. Manage Asthma Exacerbations 5. Special Considerations Asthma Management and Prevention Program: Five Components Revised 2006

Asthma Management and Prevention Program Goals of Long-term Management
Achieve and maintain control of symptoms
Maintain normal activity levels, including exercise
Maintain pulmonary function as close to normal levels as possible
Prevent asthma exacerbations
Avoid adverse effects from asthma medications
Prevent asthma mortality

Asthma can be effectively controlled in most patients by intervening to suppress and reverse inflammation as well as treating bronchoconstriction and related symptoms
Early intervention to stop exposure to the risk factors that sensitized the airway may help improve the control of asthma and reduce medication needs.
.

Although there is no cure for asthma, appropriate management that includes a partnership between the physician and the patient/family most often results in the achievement of control

Guidelines on asthma management should be available but adapted and adopted for local use by local asthma planning teams
Clear communication between health care professionals and asthma patients is key to enhancing compliance
Asthma Management and Prevention Program Component 1: Develop Patient/Doctor Partnership

Educate continually
Include the family
Provide information about asthma
Provide training on self-management skills
Emphasize a partnership among health care providers, the patient, and the patient’s family

Key factors to facilitate communication:
Friendly demeanor
Interactive dialogue
Encouragement and praise
Provide appropriate information
Feedback and review

Your Regular Treatment: 1. Each day take ___________________________ 2. Before exercise, take _____________________ WHEN TO INCREASE TREATMENT Assess your level of Asthma Control In the past week have you had: Daytime asthma symptoms more than 2 times ? No Yes Activity or exercise limited by asthma? No Yes Waking at night because of asthma? No Yes The need to use your [rescue medication] more than 2 times? No Yes If you are monitoring peak flow, peak flow less than________? No Yes If you answered YES to three or more of these questions, your asthma is uncontrolled and you may need to step up your treatment. HOW TO INCREASE TREATMENT STEP-UP your treatment as follows and assess improvement every day: ____________________________________________ [Write in next treatment step here] Maintain this treatment for _____________ days [specify number] WHEN TO CALL THE DOCTOR/CLINIC . Call your doctor/clinic: _______________ [provide phone numbers] If you don’t respond in _________ days [specify number] ______________________________ [optional lines for additional instruction] EMERGENCY/SEVERE LOSS OF CONTROL  If you have severe shortness of breath, and can only speak in short sentences,  If you are having a severe attack of asthma and are frightened,  If you need your reliever medication more than every 4 hours and are not improving. 1. Take 2 to 4 puffs ___________ [reliever medication ] 2. Take ____mg of ____________ [oral glucocorticosteroid] 3. Seek medical help: Go to _____________________; Address___________________ Phone: _______________________ 4. Continue to use your _________[ reliever medication] until you are able to get medical help. Example Of Contents Of An Action Plan To Maintain Asthma Control

Asthma Management and Prevention Program Factors Involved in Non-Adherence
Medication Usage
Difficulties associated with inhalers
Complicated regimens
Fears about, or actual side effects
Cost
Distance to pharmacies
Non-Medication Factors
Misunderstanding/lack of information
Fears about side-effects
Inappropriate expectations
Underestimation of severity
Attitudes toward ill health
Cultural factors
Poor communication

Asthma Management and Prevention Program Component 2: Identify and Reduce Exposure to Risk Factors
Measures to prevent the development of asthma, and asthma exacerbations by avoiding or reducing exposure to risk factors should be implemented wherever possible.
Asthma exacerbations may be caused by a variety of risk factors – allergens, viral infections, pollutants and drugs.
Reducing exposure to some categories of risk factors improves the control of asthma and reduces medications needs.

Reduce exposure to indoor allergens
Avoid tobacco smoke
Avoid vehicle emission
Identify irritants in the workplace
Explore role of infections on asthma development, especially in children and young infants
Asthma Management and Prevention Program Component 2: Identify and Reduce Exposure to Risk Factors

Asthma Management and Prevention Program Influenza Vaccination
Influenza vaccination should be provided to patients with asthma when vaccination of the general population is advised
However, routine influenza vaccination of children and adults with asthma does not appear to protect them from asthma exacerbations or improve asthma control

Asthma Management and Prevention Program Component 3: Assess, Treat and Monitor Asthma The goal of asthma treatment, to achieve and maintain clinical control, can be achieved in a majority of patients with a pharmacologic intervention strategy developed in partnership between the patient/family and the health care professional

Asthma Management and Prevention Program Component 3: Assess, Treat and Monitor Asthma
Depending on level of asthma control, the patient is assigned to one of five treatment steps
Treatment is adjusted in a continuous cycle driven by changes in asthma control status. The cycle involves:
- Assessing Asthma Control
- Treating to Achieve Control
- Monitoring to Maintain Control

A stepwise approach to pharmacological therapy is recommended
The aim is to accomplish the goals of therapy with the least possible medication
Although in many countries traditional methods of healing are used, their efficacy has not yet been established and their use can therefore not be recommended

The choice of treatment should be guided by:
Level of asthma control
Current treatment
Pharmacological properties and availability of the various forms of asthma treatment
Economic considerations
Cultural preferences and differing health care
systems need to be considered

Component 4: Asthma Management and Prevention Program Controller Medications
Inhaled glucocorticosteroids
Leukotriene modifiers
Long-acting inhaled β 2 -agonists
Systemic glucocorticosteroids
Theophylline
Cromones
Long-acting oral β 2 -agonists
Anti-IgE

Estimate Comparative Daily Dosages for Inhaled Glucocorticosteroids by Age
Drug Low Daily Dose (  g) Medium Daily Dose (  g) High Daily Dose (  g)
> 5 y Age < 5 y > 5 y Age < 5 y > 5 y Age < 5 y
>1000 >500-1000 250-500 Budesonide-Neb Inhalation Suspension >1000 >400 600-1000 >200-400 200-600 100-200 Budesonide >800-1200 >400 > 400-800 >200-400 200-400 100-200 Mometasone furoate >2000 >1200 >1000-2000 >800-1200 400-1000 400-800 Triamcinolone acetonide >500 >500 >250-500 >200-500 100-250 100-200 Fluticasone >2000 >1250 >1000-2000 >750-1250 500-1000 500-750 Flunisolide >320-1280 >320 >160-320 >160-320 80 – 160 80-160 Ciclesonide >1000 >400 >500-1000 >200-400 200-500 100-200 Beclomethasone

Component 4: Asthma Management and Prevention Program Reliever Medications
Rapid-acting inhaled β 2 -agonists
Anticholinergics
Theophylline
Short-acting oral β 2 -agonists

Component 4: Asthma Management and Prevention Program Allergen-specific Immunotherapy
Greatest benefit of specific immunotherapy using allergen extracts has been obtained in the treatment of allergic rhinitis
The role of specific immunotherapy in asthma is limited
Specific immunotherapy should be considered only after strict environmental avoidance and pharmacologic intervention, including inhaled glucocorticosteroids, have failed to control asthma
Perform only by trained physician

controlled partly controlled uncontrolled exacerbation LEVEL OF CONTROL maintain and find lowest controlling step consider stepping up to gain control step up until controlled treat as exacerbation TREATMENT OF ACTION TREATMENT STEPS REDUCE INCREASE STEP 1 STEP 2 STEP 3 STEP 4 STEP 5 REDUCE INCREASE

Step 1 – As-needed reliever medication
Patients with occasional daytime symptoms of short duration
A rapid-acting inhaled β 2 -agonist is the recommended reliever treatment ( Evidence A )
When symptoms are more frequent, and/or worsen periodically, patients require regular controller treatment ( step 2 or higher)
Treating to Achieve Asthma Control

Step 2 – Reliever medication plus a single controller
A low-dose inhaled glucocorticosteroid is recommended as the initial controller treatment for patients of all ages ( Evidence A )
Alternative controller medications include leukotriene modifiers ( Evidence A ) appropriate for patients unable/unwilling to use inhaled glucocorticosteroids

Step 3 – Reliever medication plus one or two controllers
For adults and adolescents, combine a low-dose inhaled glucocorticosteroid with an inhaled long-acting β 2 -agonist either in a combination inhaler device or as separate components ( Evidence A )
Inhaled long-acting β 2 -agonist must not be used as monotherapy
For children, increase to a medium-dose inhaled glucocorticosteroid ( Evidence A )

Additional Step 3 Options for Adolescents and Adults
Increase to medium-dose inhaled glucocorticosteroid ( Evidence A )
Low-dose inhaled glucocorticosteroid combined with leukotriene modifiers ( Evidence A )
Low-dose sustained-release theophylline ( Evidence B )

Step 4 – Reliever medication plus two or more controllers
Selection of treatment at Step 4 depends on prior selections at Steps 2 and 3
Where possible, patients not controlled on Step 3 treatments should be referred to a health professional with expertise in the management of asthma

Step 4 – Reliever medication plus two or more controllers
Medium- or high-dose inhaled glucocorticosteroid combined with a long-acting inhaled β 2 -agonist ( Evidence A )
Medium- or high-dose inhaled glucocorticosteroid combined with leukotriene modifiers ( Evidence A )
Low-dose sustained-release theophylline added to medium- or high-dose inhaled glucocorticosteroid combined with a long-acting inhaled β 2 -agonist ( Evidence B )

Step 5 – Reliever medication plus additional controller options
Addition of oral glucocorticosteroids to other controller medications may be effective ( Evidence D ) but is associated with severe side effects ( Evidence A )
Addition of anti-IgE treatment to other controller medications improves control of allergic asthma when control has not been achieved on other medications ( Evidence A )

Treating to Maintain Asthma Control
When control as been achieved, ongoing monitoring is essential to:
- maintain control
- establish lowest step/dose treatment
Asthma control should be monitored by the health care professional and by the patient

Treating to Maintain Asthma Control Stepping down treatment when asthma is controlled
When controlled on medium- to high-dose inhaled glucocorticosteroids: 50% dose reduction at 3 month intervals ( Evidence B )
When controlled on low-dose inhaled glucocorticosteroids: switch to once-daily dosing ( Evidence A )

Treating to Maintain Asthma Control Stepping down treatment when asthma is controlled
When controlled on combination inhaled glucocorticosteroids and long-acting inhaled β 2 -agonist, reduce dose of inhaled glucocorticosteroid by 50% while continuing the long-acting β 2 -agonist ( Evidence B )
If control is maintained, reduce to low-dose inhaled glucocorticosteroids and stop long-acting β 2 -agonist ( Evidence D )

Treating to Maintain Asthma Control Stepping up treatment in response to loss of control
Rapid-onset, short-acting or long-acting inhaled β 2-agonist bronchodilators provide temporary relief.
Need for repeated dosing over more than one/two days signals need for possible increase in controller therapy

Treating to Maintain Asthma Control Stepping up treatment in response to loss of control
Use of a combination rapid and long-acting inhaled β 2 -agonist ( e.g., formoterol) and an inhaled glucocorticosteroid ( e.g., budesonide) in a single inhaler both as a controller and reliever is effecting in maintaining a high level of asthma control and reduces exacerbations ( Evidence A )
Doubling the dose of inhaled glucocortico-steroids is not effective, and is not recommended ( Evidence A )

Childhood and adult asthma share the same underlying mechanisms. However, because of processes of growth and development, effects of asthma treatments in children differ from those in adults. Asthma Management and Prevention Program Component 3: Assess, Treat and Monitor Asthma – Children 5 Years and Younger

Many asthma medications ( e.g. glucocorticosteroids, β 2 - agonists, theophylline) are metabolized faster in children than in adults, and younger children tend to metabolize medications faster than older children Asthma Management and Prevention Program Component 3: Assess, Treat and Monitor Asthma – Children 5 Years and Younger

Long-term treatment with inhaled glucocorticosteroids has not been shown to be associated with any increase in osteoporosis or bone fracture
Studies including a total of over 3,500 children treated for periods of 1 – 13 years have found no sustained adverse effect of inhaled glucocorticosteroids on growth
Asthma Management and Prevention Program Component 3: Assess, Treat and Monitor Asthma – Children 5 Years and Younger

Rapid-acting inhaled β 2 -agonists are the most effective reliever therapy for children
These medications are the most effective bronchodilators available and are the treatment of choice for acute asthma symptoms
Asthma Management and Prevention Program Component 3: Assess, Treat and Monitor Asthma – Children 5 Years and Younger

Exacerbations of asthma are episodes of progressive increase in shortness of breath, cough, wheezing, or chest tightness
Exacerbations are characterized by decreases in expiratory airflow that can be quantified and monitored by measurement of lung function (FEV 1 or PEF)
Severe exacerbations are potentially life-threatening and treatment requires close supervision
Asthma Management and Prevention Program Component 4: Manage Asthma Exacerbations

Primary therapies for exacerbations:
Repetitive administration of rapid-acting inhaled β 2 -agonist
Early introduction of systemic glucocorticosteroids
Oxygen supplementation
Closely monitor response to treatment with serial
measures of lung function
Asthma Management and Prevention Program Component 4: Manage Asthma Exacerbations

Asthma Management and Prevention Program Special Considerations
Special considerations are required to
manage asthma in relation to:
Pregnancy
Surgery
Rhinitis, sinusitis, and nasal polyps
Occupational asthma
Respiratory infections
Gastroesophageal reflux
Aspirin-induced asthma
Anaphylaxis and Asthma

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Gina - global initiative against asthma

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