gina 19 in brief

1. GINA – RECENT GUIDELINES
DR ANUSHA CM

2. Whats is GINA ?
• The Global Initiative for Asthma (GINA) was established by the World
Health Organization and the National Heart Lung and Blood Institute in
1993, to increase awareness about asthma among health professionals,
public health authorities and the community, and to improve asthma
prevention and management through a coordinated worldwide effort.
• GINA prepares scientific reports on asthma, encourages dissemination and
implementation of the recommendations, and promotes international
collaboration on asthma research.
• It is updated annually which comprises an integrated strategy focusing not
only on evidence, but also on translation into clinical practice.

3. Defining Asthma
• Asthma is a heterogeneous disease, usually characterized by chronic airway
inflammation.
• It is defined by the history of respiratory symptoms such as wheeze,
shortness of breath, chest tightness and cough that vary over time and in
intensity, together with variable expiratory airflow limitation.
• Airflow limitation may later become persistent.
• Asthma is a common, chronic respiratory disease affecting 1–18% of the
population in different countries

4. Asthma phenotypes
• These are recognizable clusters of demographic, clinical and/or
pathophysiological characteristics.
• Many clinical phenotypes of asthma have been identified.
1. Allergic asthma
• Commences in childhood
• Associated with a past and/or family history of allergic disease such as
eczema, allergic rhinitis, or food or drug allergy
• Sputum reveals eosinophilic airway inflammation
• Respond well to inhaled corticosteroid (ICS) treatment.

5. 2. Non-allergic asthma
• Not associated with allergy
• Sputum may be neutrophilic, eosinophilic or contain only a few
inflammatory cells (pauci-granulocytic)
• Demonstrate less short-term response to ICS.
3. Adult-onset (late-onset) asthma
• Non-allergic
• Affects adults , particularly women
• Require higher doses of ICS or are relatively refractory to corticosteroid
treatment
• Occupational asthma to be ruled out in such patients

6. 4. Asthma with persistent airflow limitation
• long-standing asthma develop airflow limitation that is persistent or
incompletely reversible
• thought to be due to airway wall remodeling.
5. Asthma with obesity
• obese patients with asthma have prominent respiratory symptoms and
little eosinophilic airway inflammation.

7. DIAGNOSTIC
CRITERIA

8. OTHER TESTS
1. Bronchial provocation tests
• Performed to assess airway hyperresponsiveness
• Agents used: inhaled methacholine, histamine, exercise, eucapnic
voluntary hyperventilation or inhaled mannitol.
• Moderately sensitive for a diagnosis of asthma but have limited specificity
• This means that a negative test in a patient not taking ICS can help to
exclude asthma, but a positive test does not always mean that a patient
has asthma

9. 2. Allergy tests
• Atopy increases the probability that a patient with respiratory symptoms
has allergic asthma, but not specific for asthma nor is it present in all
asthma phenotypes.
• Atopic status can be identified by skin prick testing or by measuring the
level of specific immunoglobulin E (S.IgE) in serum.
• The presence of a positive skin test or positive S.IgE, however, does not
mean that the allergen is causing symptoms - the relevance of allergen
exposure and its relation to symptoms must be confirmed by the patient’s
history.

10. 3. FENO(fractional concentration of exhaled nitric oxide )
• Associated with levels of sputum and blood eosinophils
• FENO is higher in asthma that is characterized by Type 2 airway inflammation
• Also elevated in non- asthma conditions (e.g. eosinophilic bronchitis, atopy,
allergic rhinitis, eczema)
• FENO is lower in smokers and during bronchoconstriction and the early phases
• May be increased or decreased during viral respiratory infections.
• FENO has not been established as useful for ruling in or ruling out a diagnosis of
asthma
• Hence , FENO cannot be recommended at present for deciding against treatment
with ICS

11. ASSESSMENT OF ASTHMA
What is meant by ‘asthma control?
• The level of asthma control is the extent to which the manifestations of
asthma can be observed in the patient, or have been reduced or removed
by treatment.
• Determined by the interaction between the patient’s genetic background,
underlying disease processes, the treatment that they are taking,
environment, and psychosocial factors
• Asthma control is assessed in two domains:
1. Symptom control
2. Future risk of adverse outcomes

12. How to assess a
patient with
asthma ?

13. • Assess symptom control from the frequency of daytime and night-
time asthma symptoms and reliever use, and from activity limitation.
• Symptom control tools include Asthma Control Test and Asthma
Control Questionnaire.
Numerical ‘asthma control’ tools
• Provide scores and cut points to distinguish different levels of
symptom control, validated against health care provider assessment.

14. 1. ASTHMA CONTROL
QUESTIONNAIRE (ACQ)
Score range from 0-6( higher is worse)
0-0.75: Well controlled asthma
0.75-1.5: Grey zone
>1.5 : Poor controlled asthma

15. 2.ASTHMA CONTROL TEST
Score range from 5-25( higher is better)
20-25: well controlled
16-19: not well controlled
5-15: poorly controlled

16. ASSESSING ASTHMA SEVERITY
• Asthma severity can be assessed when the patient has been on regular
controller treatment for several months:
1. Mild asthma : well controlled with Step 1 or Step 2 treatment, i.e. with
as-needed controller medication alone, or with low-intensity
maintenance controller treatment such as low dose ICS, leukotriene
receptor antagonists.
2. Moderate asthma : well controlled with Step 3 treatment e.g. low dose
ICS-LABA.
3. Severe asthma : requires Step 4 or 5 treatment, e.g. high-dose ICS-LABA,
to prevent it from becoming ‘uncontrolled’, or asthma that remains
‘uncontrolled’ despite this treatment.

17. MANAGING ASTHMA
Goals of asthma management
• The long-term goals of asthma management are to achieve good
symptom control
• Minimize future risk of asthma-related mortality, exacerbations,
persistent airflow limitation and side-effects of treatment.

18. CONTROL BASED ASTHMA MANAGEMENT
• Pharmacological and non-pharmacological treatment is adjusted in a
continuous cycle that involves assessment, treatment and review
• In control-based management, both domains of asthma control
(symptom control and future risk ) should be taken into account when
choosing asthma treatment and reviewing the response.

20. Alternative strategies for adjusting asthma treatment
1. Treatment guided by sputum eosinophil count
• In this approach, leads to a reduced risk of exacerbations and similar
levels of symptom control and lung function
• Primarily seen in patients requiring secondary care
• Disadvantage : only a limited number of centers have routine access
to induced sputum analysis.

21. 2. Treatment guided by fractional concentration of exhaled nitric
oxide (FENO)
• No significant differences were seen in symptoms or ICS dose with
FENO-guided treatment compared with other strategies
• At present, neither sputum- nor FENO-guided treatment is
recommended for the general asthma population.

22. Medications and strategies for symptom control
and risk reduction
• For safety, GINA no longer recommends treatment of asthma in
adults and adolescents with SABA alone. This was included in GINA
2014-18, but with high probability of poor adherence
• GINA recommends that all adults and adolescents with asthma
should receive ICS-containing controller treatment, either as-needed
(in mild asthma) or daily, to reduce their risk of serious exacerbations
and to control symptoms

23. * Off-label; data only with budesonide-formoterol (bud-form)
† Off-label; separate or combination ICS and SABA inhalers
STEP 2
Daily low dose inhaled corticosteroid (ICS),
or as-needed low dose ICS-formoterol *
STEP 3
Low dose
ICS-LABA
STEP 4
Medium dose
ICS-LABA
Leukotriene receptor antagonist (LTRA), or
low dose ICS taken whenever SABA taken †
As-needed low dose ICS-formoterol *
As-needed short-acting β2 -agonist (SABA)
Medium dose
ICS, or low dose
ICS+LTRA #
High dose
ICS, add-on
tiotropium, or
add-on LTRA #
Add low dose
OCS, but
consider
side-effects
As-needed low dose ICS-formoterol ‡
STEP 5
High dose
ICS-LABA
Refer for
phenotypic
assessment
± add-on
therapy,
e.g.tiotropium,
anti-IgE,
anti-IL5/5R,
anti-IL4R
Symptoms
Exacerbations
Side-effects
Lung function
Patient satisfaction
Confirmation of diagnosis if necessary
Symptom control & modifiable
risk factors (including lung function)
Comorbidities
Inhaler technique & adherence
Patient goals
Treatment of modifiable risk
factors & comorbidities
Non-pharmacological strategies
Education & skills training
Asthma medications
1© Global Initiative for Asthma, www.ginasthma.org
STEP 1
As-needed
low dose
ICS-formoterol *
Low dose ICS
taken whenever
SABA is taken†
‡ Low-dose ICS-form is the reliever for patients prescribed
bud-form or BDP-form maintenance and reliever therapy
# Consider adding HDM SLIT for sensitized patients with
allergic rhinitis and FEV >70% predicted
PREFERRED
CONTROLLER
to prevent exacerbations
and control symptoms
Other
controller options
Other
reliever option
PREFERRED
RELIEVER
Box 3-5A
Adults & adolescents 12+ years
Personalized asthma management:
Assess, Adjust, Review response
Asthma medication options:
Adjust treatment up and down for
individual patient needs

24. 1.Controller medications
• Used to reduce airway inflammation, control symptoms, and reduce future risks
such as exacerbations and decline in lung function
• With mild asthma, controller treatment may be delivered through as-needed low
dose ICS-formoterol, taken when symptoms occur and before exercise.
2. Reliever (rescue) medications
• Provided to all patients for as-needed relief of breakthrough symptoms, including
during worsening asthma or exacerbations.
• Also recommended for short-term prevention of exercise-induced
bronchoconstriction
• Reducing and, ideally, eliminating the need for reliever treatment is both an
important goal in asthma management and a measure of the success of asthma
treatment.

25. 3.Add-on therapies for patients with severe asthma
• Considered when patients have persistent symptoms and/or
exacerbations despite optimized treatment with high dose controller
medications (usually a high dose ICS and a LABA) and treatment of
modifiable risk factors

26. Treatment options that may be considered after optimization of
existing therapy may include the following
1. Combination high dose ICS-LABA: very little benefit
2. Add-on tiotropium : in patients aged ≥6 years whose asthma is not well-
controlled with ICS-LABA.
3. Add-on azithromycin (three times a week, off-label): for adult patients
with persistent symptomatic asthma despite moderate-high dose ICS and
LABA reduced asthma exacerbations in eosinophilic and non- eosinophilic
asthma
4. Add-on anti-immunoglobulin E (anti-IgE) (omalizumab) treatment: for
patients aged ≥6 years with moderate or severe allergic asthma that is
uncontrolled on Step 4-5 treatment

27. 4. Add-on anti-interleukin-5/5R treatment (subcutaneous mepolizumab for patients
aged ≥12 years; intravenous reslizumab for ages ≥18 years) or anti-interleukin 5
receptor treatment (subcutaneous benralizumab for ages >12 years , with severe
eosinophilic asthma that is uncontrolled in Step 4 or 5 treatment
5. Add-on anti-interleukin-4R α treatment (subcutaneous dupilumab) for patients
aged ≥12 years with severe ≥12 years), with severe eosinophilic asthma that is
uncontrolled on Step 4-5 treatment (Evidence A)
6. Sputum-guided treatment: for adults with persisting symptoms and/or
exacerbations despite high-dose ICS or ICS-LABA, treatment may be adjusted based
on eosinophilia (>3%) in induced sputum. In severe asthma, this strategy leads to
reduced exacerbations and/or lower doses of ICS (Evidence A).
7. Add-on treatment with bronchial thermoplasty: may be considered for some
adult patients with severe asthma (Evidence B). Evidence is limited and in selected
patients . The long term effects compared with control patients, including for lung
function, are not known.

28. 8. Add-on low dose oral corticosteroids (≤7.5 mg/day prednisone equivalent)
• May be effective for some adults with severe asthma (Evidence D), but are often
associated with substantial side effects(Evidence B)
• They should only be considered for adults with poor symptom control and/or
frequent exacerbations despite good inhaler technique and adherence with Step
4 treatment, and after exclusion of other contributory factors and other add-on
treatments
• They should be assessed and monitored for risk of corticosteroid-induced
osteoporosis, and those expected to be treated for ≥3 months should be provided
with relevant lifestyle counselling and prescription of therapy for prevention of
osteoporosis

29. Stepping down to find the minimum effective dose
• Consider step down once good asthma control has been achieved and
maintained for about 3 months, to find the patient’s lowest treatment that
controls both symptoms and exacerbations
• Provide the patient with a written asthma action plan, monitor closely, and
schedule a follow-up visit
• Do not completely withdraw ICS unless this is needed temporarily to
confirm the diagnosis of asthma.

30. NON-PHARMACOLOGICAL STRATEGIES
1. Cessation of smoking and Environmental Tobacco Smoke exposure
2. Encourage people with asthma to engage in regular physical activity
for its general health benefits
3. Avoidance of occupational exposures
4. Avoidance of medications like NSAIDs , oral or intra-ocular beta-
blockers that may make asthma worse
5. Avoidance of indoor allergens like house dust mite and/or pet
6. Avoidance of indoor air pollution
7. Avoidance of outdoor allergens
8. Avoidance of outdoor air pollutants/ weather conditions
9. Avoidance of foods and food chemicals

31. 10. Breathing exercises may be a useful supplement to asthma
pharmacotherapy for symptoms and quality of life, but they do not
improve lung function or reduce exacerbation risk
11. Encourage patients with asthma to consume a diet high in fruit and
vegetables for its general health benefits.
12. Weight reduction : For obese adults with asthma a weight reduction
program plus twice-weekly aerobic and strength exercises is more
effective for symptom control than weight reduction alone
13. Encourage patients to identify goals and strategies to deal with
emotional stress if it makes their asthma worse

32. DIFFICULT-TO-TREAT AND SEVERE ASTHMA IN ADULTS AND
ADOLESCENTS
Uncontrolled asthma includes one or both of the following:
• Poor symptom control (frequent symptoms or reliever use, activity limited by asthma, night waking
due to asthma)
• Frequent exacerbations (≥2/year) requiring oral corticosteroids (OCS), or serious exacerbations
(≥1/year) requiring hospitalization
Difficult-to-treat asthma
• Asthma that is uncontrolled despite GINA Step 4 or 5 treatment (e.g. medium or high dose inhaled
corticosteroids (ICS) with a second controller; maintenance OCS), or that requires such treatment to
maintain good symptom control and reduce the risk of exacerbations.
Severe asthma
• A subset of difficult-to-treat asthma. It means asthma that is uncontrolled despite adherence with
maximal optimized therapy and treatment of contributory factors, or that worsens when high dose
treatment is decreased

37. Management of asthma exacerbations in acute
care facility, e.g. emergency department

39. Asthma-COPD overlap (ACO)
• Distinguishing asthma from COPD , particularly in smokers and older adults
is difficult , having clinical features of both asthma and COPD
• The term asthma-COPD overlap does not describe a single disease entity.

42. THANK YOU

44. Whats new in GINA 2019
• SABA- only treatment is no longer recommended for treatment of asthma
in adults and adolescents. This change was based on strong evidence that
SABA-only treatment increases the risk of severe exacerbations and
asthma-related death, and that adding any ICS significantly reduces the risk
• GINA now recommends that all adults and adolescents with asthma should
receive either symptom-driven(in mild asthma) or daily inhaled
corticosteroid (ICS)-containing controller treatment, to reduce the risk of
severe exacerbations and asthma-related death
• Off-label recommendations: the recommendations for long-term
azithromycin in moderate-severe asthma,in mild asthma, for as-needed
ICS-formoterol or ICS taken whenever SABA is taken

45. • Tiotropium is now approved as add-on therapy for ages 6 years and older
• Add-on low dose azithromycin(off label,as above) is recommended as an
option for patients with symptomatic asthma despite moderate-high dose
ICS-LABA, after consideration of potential adverse effects
• High dose ICS-LABA treatment is now recommended only in Step5
(previously, Step 4 treatment included moderate- high dose ICS-LABA)
• Dupilumab(anti-IL4 receptor α) is now recommended as an additional
treatment option for patients ≥12 years with severe Type 2 asthma or OCS-
dependent asthma

46. • Maintenance oral corticosteroids (OCS) are not a ‘preferred’
treatment in Step5, because of the high risk of adverse outcomes.