GINA 2019 presentation

Global Strategy for Asthma
Management and Prevention
(2019 update)
Dr. Md. Shafiqul Islam Dewan
Phase-A Resident (Pulmonology)
Medicine Unit - VIII
Dhaka Medical College Hospital

About GINA
GINA stands for Global Initiative for Asthma.
Established in 1993.
Work with health care professionals and public
health officials around the world.
To reduce asthma prevalence, morbidity, and
mortality.

Asthma
Asthma is a heterogeneous disease.
Characterized by chronic airway inflammation.
Causing symptoms such as wheezing, shortness of
breath, chest tightness and cough.
That varies in frequency and intensity together
with variable expiratory airflow limitation.

Phenotypes of Asthma
Many phenotypes have been identified. Most
common phenotypes are:
Allergic asthma
Non-allergic asthma
Adult-onset (Late onset) asthma
Asthma with fixed airway limitation
Asthma with obesity

Diagnosis of Asthma
Diagnosis of asthma depends on two
defining features:
History of respiratory symptoms such as
wheeze, shortness of breath, chest tightness
and cough that vary over time and in intensity.
Variable expiratory airflow limitation.

Patient with respiratory symptoms
Are the symptoms typical of
Asthma?
Details History and Examination
History and Examination Supports
Asthma Diagnosis?
Perform Spirometry / PEF with
Reversibility test
Result Support Asthma Diagnosis?
Treat for Asthma
Yes
Yes
Yes
Empiric treatment
with ICS and prn SABA
Review response
Diagnostic testing
within 1-3 months Treat for Alternative
Diagnosis
Further History &
Test for Alternative
Diagnosis
Clinical urgency
Other diagnosis
unlikely
No
Y
e
s
Diagnostic flow-chart for Asthma in clinical practice

Assessing a patient with Asthma
Assess asthma control
Assess risk factor
Assess for comorbidities
Assess treatment issue

Assess asthma control
Level of asthma symptom control.
In the past 4 weeks,
has the patient had
Well
controlled
Partly
controlled
Uncontrolled
Daytime symptoms more
than twice/week?
Yes/No
None of
these
1 - 2
of these
3 - 4
of these
Reliever needed more
than twice/week?
Yes/No
Any night waking due to
asthma?
Yes/No
Any activity limitation
due to asthma?
Yes/No

Assess risk factor
Risk factor for exacerbations
Risk factors for developing fixed airflow
limitation
Risk factors for medication side-effects

Risk factor for exacerbations
Uncontrolled asthma symptoms
Comorbidities
Exposures to smoking, allergen and air pollution
Major socioeconomic problems
Medication: Inhaled corticosteroid (ICS) not
prescribed, Poor adherence, Incorrect inhaler
technique, High (SABA) use.

Risk factors for developing fixed airflow limitation
Preterm birth, LBW and greater infant weight gain.
Lack of ICS treatment
Exposure to tobacco smoke and noxious chemicals
Low FEV1
Chronic mucus hyper-secretion
Sputum or blood eosinophilia

Risk factors for medication side-effects
Frequent oral corticosteroid use.
Long term high-dose or potent ICS use.
Poor inhaler technique.

Assess for comorbidities
Rhinitis
Chronic Rhinosinusitis
Gastroesophageal reflux(GERD)
Obesity
Obstructive sleep apnea
Depression and anxiety
Pregnancy

Assess treatment issue
Record the patient’s treatment and ask about side
effects.
Check that the patient has a written asthma
action plan.
Ask the patient about their attitudes and goals for
their asthma.

Written asthma action plan
The written asthma action plan should
include:
The patient’s usual asthma medications
When and how to increase medications and
start oral corticosteroid(OCS)
How to access medical care if symptoms fail to
respond

Management of Asthma
Few asthma symptoms
No sleep disturbance
No exercise limitation
Maintain normal lung function
Prevent flare-ups (exacerbations)
Prevent asthma deaths
Avoid medication side-effects
Symptom control
Risk reduction

Management of Asthma
General management
Asthma medication
Treatment of modifiable risk factor
Treatment of comorbidity
Non pharmacological therapies and strategies
Follow up

General management
Patient education regarding Asthma
Inhaler skills
Adherence
Written asthma action plan
Self-monitoring of symptoms and/or peak flow
Regular medical review

Asthma Medication
Controller medication
Add-on controller medication
Reliever medication

Controller Medication
Inhaled corticosteroids (ICS)
ICS and long-acting beta2 agonist (LABA)
bronchodilator combinations (ICS- LABA )
Leukotriene modifiers
Chromones

Inhaled corticosteroids (ICS)
Beclomethasone dipropionate
Budesonide
Fluticasone propionate
Fluticasone furoate
Ciclesonide
Triamcinolone

Low, Medium and High dose of ICS
Inhaled corticosteroid
Adult and Adolescent
Low(mcg) Medium(mcg) High(mcg)
Beclomethasone dipropionate 100-200 >200-400 >400
Budesonide (DPI) 200-400 >400-800 >800
Fluticasone propionate (DPI) 100-250 >250-500 >500
Fluticasone propionate(HFA) 100-250 >250-500 >500
Triamcinolone acetonide 400-1000 >1000-
2000
>2000

ICS and long-acting beta2 agonist
bronchodilator combinations (ICS-LABA)
Beclometasone-formoterol
Budesonide-formoterol
Fluticasone propionate-formoterol
Fluticasone propionate-salmeterol
Fluticasone furoate-vilanterol

Leukotriene modifiers
Montelukast
Pranlukast
Zafirlukast
Zileuton
Chromones
Sodium cromoglycate
Nedocromil sodium

Add-on Controller Medication
Long-acting anticholinergic
Anti-IgE
Anti-IL5
Anti-IL5R
Anti-IL4R
Systemic corticosteroids

Long-acting anticholinergic (At Step 4 or 5 with a
history of exacerbations despite ICS ± LABA)
Tiotropium
Anti-IgE (with severe allergic asthma uncontrolled
on high dose ICS-LABA)
Omalizumab

 Anti-IL5 & Anti-IL5R (Severe eosinophilic asthma
uncontrolled on high dose ICS-LABA)
Mepolizumab & Reslizumab
Benralizumab
 Anti-IL4R (Severe eosinophilic asthma uncontrolled on
high dose ICS-LABA, or requiring maintenance OCS)
 Dupilumab

Systemic corticosteroids
Prednisolone
Hydrocortisone
Methylprednisolone

Reliever Medication
Short-acting inhaled beta2-agonist
bronchodilators (SABA)
Low-dose ICS-formoterol
Short-acting anticholinergics

Reliever Medication
Short-acting inhaled beta2-agonist
bronchodilators (SABA)
Salbutamol
Terbutaline

Reliever Medication
• Low-dose ICS-formoterol
• Beclometasone-formoterol
• Budesonide-formoterol
• Short-acting anticholinergics
• Ipratropium bromide
• Oxitropium bromide

Treatment of modifiable risk factor

Non pharmacological therapies and strategies
Cessation of smoking
Physical activity
Healthy diet
Weight reduction
Breathing exercises
Avoidance of occupational exposures

Non pharmacological therapies and strategies
Avoidance of indoor allergens and air pollution
Avoidance of outdoor air pollutants / weather
conditions
Avoidance of medications that may make asthma
worse

Other therapies
Allergen immunotherapy
Subcutaneous immunotherapy (SCIT) (Evidence D)
Sublingual immunotherapy (SLIT) (Evidence B)
Bronchial thermoplasty. (Evidence B)

Starting asthma treatment
ICS-containing treatment should be initiated as soon
as possible after the diagnosis of asthma is made.
Consider starting at a higher step (e.g. medium/high
dose ICS, or low-dose ICS-LABA) if on most days the
patient has troublesome asthma symptoms; or is
waking from asthma once or more a week.

Starting asthma treatment
If the initial asthma presentation is with severely
uncontrolled asthma, or with an acute exacerbation,
give a short course of OCS and start regular controller
treatment (e.g. medium dose ICS-LABA).
Consider stepping down after asthma has been well-
controlled for 3 months. However, in adults and
adolescents, ICS should not be completely stopped.

Before starting initial controller treatment
Record evidence for the diagnosis of asthma, if
possible.
Document symptom control and risk factors.
Assess lung function, when possible.
Train the patient to use the inhaler correctly and
check their technique.
Schedule a follow-up visit.

After starting initial controller treatment
Review response after 2–3 months, or according
to clinical urgency.
Review for ongoing treatment and other key
management issues.
Consider step down when asthma has been well-
controlled for 3 months

Reviewing response and adjusting treatment
Patients should preferably be seen 1–3 months
after starting treatment
Every 3–12 months after that, but in pregnancy,
asthma should be reviewed every 4–6 weeks.
After an exacerbation, a review visit within 1
week should be scheduled

Stepping up asthma treatment
• Sustained step-up (for at least 2–3 months): if symptoms
and/or exacerbations persist despite 2–3 months of
controller treatment, assess the following common
issues before considering a step-up
• Incorrect inhaler technique
• Poor adherence
• Modifiable risk factors
• Comorbid conditions

Short-term step-up (for 1–2 weeks) by
clinician or by patient with written asthma
action plan, e.g. during viral infection or
allergen exposure.

• Day-to-day adjustment by patient for those
who prescribed as-needed low dose ICS-
formoterol for mild asthma, or low dose
ICS-formoterol as maintenance and reliever
therapy.

Stepping down asthma treatment
Consider stepping down treatment once
good asthma control has been achieved and
maintained for 3 months, to find the lowest
treatment that controls both symptoms and
exacerbations, and minimizes side-effects.

Stepping down asthma treatment
Choose an appropriate time for step-down (no
respiratory infection, patient not travelling, not
pregnant).
Document baseline status (symptom control and
lung function), provide a written asthma action
plan, monitor closely and book a follow-up visit.

Control based asthma management cycle

GINA 2019 – Changes in asthma management
For safety, GINA no longer recommends SABA-
only treatment for Step 1
This decision was based on evidence that SABA-only
treatment increases the risk of severe exacerbations,
and that adding any ICS significantly reduces the risk
GINA now recommends that all adults and
adolescents with asthma should receive symptom-
driven or regular low dose ICS-containing
controller treatment, to reduce the risk of serious
exacerbations
This is a population-level risk reduction strategy, e.g.
statins, anti-hypertensives.

Background to changes in 2019
Risks of mild asthma
Patients with apparently mild asthma are at risk
of serious adverse events
30–37% of adults with acute asthma
16% of patients with near-fatal asthma
15–20% of adults dying of asthma
Exacerbation triggers are variable (viruses,
pollens, pollution, poor adherence)
had symptoms less
than weekly in previous
3 months (Dusser,
Allergy 2007)

risks of SABA-only treatment
Inhaled SABA has been first-line treatment for
asthma for 50 years
Patient satisfaction with, and reliance on, SABA
treatment is reinforced by its rapid relief of symptoms,
its prominence in emergency department and hospital
management of exacerbations, and low cost
Patients commonly believe that “My reliever gives me
control over my asthma”, so they often don’t see the
need for additional treatment

Regular or frequent use of SABA is associated
with adverse effects
β-receptor downregulation, decreased
bronchoprotection, rebound hyperresponsiveness,
decreased bronchodilator response (Hancox, Respir Med 2000)
Increased allergic response, and increased eosinophilic
airway inflammation (Aldridge, AJRCCM 2000)

Higher use of SABA is associated with adverse
clinical outcomes
Dispensing of ≥3 canisters per year (average 1.7
puffs/day) is associated with higher risk of emergency
department presentations (Stanford, AAAI 2012)
Dispensing of ≥12 canisters per year is associated with
higher risk of death (Suissa, AJRCCM 1994)

GINA 2019 - Stepwise treatment
PREFERRED
CONTROLLER
to prevent exacerbations
and control symptoms
PREFERRED
RELIEVER
Other
reliever option
STEP 1
As-needed
low dose
ICS-formoterol *
Low dose ICS
taken whenever
SABA is taken†
STEP 2
Daily low dose inhaled corticosteroid (ICS), or as-
needed low dose ICS-formoterol *
Leukotriene receptor antagonist (LTRA), or
low dose ICS taken whenever SABA taken †
STEP 3
Low dose
ICS-LABA
Medium dose
ICS, or
low dose
ICS+LTRA #
STEP 4
Medium dose
ICS-LABA
High dose
ICS, add-on
tiotropium,
or add-on
LTRA #
STEP 5
High dose
ICS-LABA
Refer for
phenotypic
assessment
± add-on
therapy,
e.g.tiotropium,
anti-IgE,
anti-IL5/5R,
anti-IL4R
Add low dose
OCS, but
consider
side-effects
As-needed low dose ICS-formoterol * As-needed low dose ICS-formoterol ‡
As-needed short-acting β2 -agonist (SABA)
* Off-label; data only with budesonide-formoterol (bud-form)
† Off-label; separate or combination ICS and SABA inhalers
‡ 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
Asthma medication options:
Adjust treatment up and down for
individual patient needs
Other
Controller option

Step 1
Rationale for changes
in GINA 2019

GINA 2019 – Step 1 Changes
PREFERRED
CONTROLLER
PREFERRED
RELIEVER
Other
reliever option
STEP 1
As-needed
low dose
ICS-formoterol *
Low dose ICS
taken whenever
SABA is taken†
STEP 2
STEP 3
Low dose
ICS-LABA
Medium dose
ICS, or
low dose
ICS+LTRA #
STEP 4
Medium dose
ICS-LABA
High dose
ICS, add-on
tiotropium,
or add-on
LTRA #
STEP 5
High dose
ICS-LABA
Refer for
phenotypic
assessment
± add-on
therapy,
e.g.tiotropium,
anti-IgE,
anti-IL5/5R,
anti-IL4R
Add low dose
OCS, but
consider
side-effects
Other
Controller option
Previously, no controller was
recommended for
Step 1, i.e. SABA-only
treatment was preferred.

Step 1 - ‘preferred’ controller option
Step 1 is for patients with symptoms less than twice a
month, and with no exacerbation risk factors
As-needed low dose ICS-formoterol (off-label)
• Evidence
• Indirect evidence from SYGMA 1 of large reduction in severe
exacerbations vs SABA-only treatment in patients eligible for Step 2
therapy (O’Byrne, NEJMed 2018)
• Values and preferences
• High importance given to reducing exacerbations
• High importance given to avoiding conflicting messages about goals
of asthma treatment between Step 1 and Step 2
• High importance given to poor adherence with regular ICS in
patients with infrequent symptoms, which would expose them to

Step 1 - other controller option
Low dose ICS taken whenever SABA is taken (off-label)
Evidence
Indirect evidence from studies in patients eligible for Step 2
treatment (BEST, TREXA, BASALT)
Values and preferences
High importance given to preventing severe exacerbations
Lower importance given to small differences in symptom control
and the inconvenience of needing to carry two inhalers
Combination ICS-SABA inhalers are available in some countries, but
approved only for maintenance use
Daily ICS is no longer listed as a Step 1 option
This was included in GINA 2014-18, but with high probability of
poor adherence
Now replaced by more feasible as-needed controller options for
Step 1

Step 2
Rationale for changes
in GINA 2019

GINA 2019 - Step 2 changes
PREFERRED
CONTROLLER
PREFERRED
RELIEVER
Other
reliever option
STEP 1
As-needed
low dose
ICS-formoterol *
Low dose ICS
taken whenever
SABA is taken†
STEP 2
STEP 3
Low dose
ICS-LABA
Medium dose
ICS, or
low dose
ICS+LTRA #
STEP 4
Medium dose
ICS-LABA
High dose
ICS, add-on
tiotropium,
or add-on
LTRA #
STEP 5
High dose
ICS-LABA
Refer for
phenotypic
assessment
± add-on
therapy,
e.g.tiotropium,
anti-IgE,
anti-IL5/5R,
anti-IL4R
Add low dose
OCS, but
consider
side-effects
Other
Controller option

Step 2 - there are two ‘preferred’ controller options
(1) Regular low dose ICS with as-needed SABA
• Evidence
A large body of evidence from RCTs and observational
studies that low dose ICS substantially reduces risks of
severe exacerbations, hospitalizations and death
e.g. Suissa, NEJMed 2000; Suissa, Thorax 2002; Pauwels, Lancet 2003; O’Byrne,
AJRCCM 2001
Serious exacerbations halved even in patients with
symptoms 0-1 days per week (Reddel, Lancet 2017)
Improved symptom control and reduced exercise-
induced bronchoconstriction

Step 2 - there are two ‘preferred’ controller options
(1) Regular low dose ICS with as-needed SABA
High importance was given to preventing asthma
deaths and severe exacerbations.
However, we were aware that poor adherence is
common in mild asthma in the community, and that
this would expose patients to the risks of SABA-only
treatment.

Step 2 - two ‘preferred’ controller options
(2) As-needed low dose ICS-formoterol
(off-label; all evidence with budesonide-formoterol)
Evidence
Direct evidence from two large studies of non-
inferiority for severe exacerbations vs daily low dose
ICS + as-needed SABA (O’Byrne, NEJMed 2018, Bateman, NEJMed 2018)
Direct evidence from one large study of 64% reduction
in severe exacerbations vs SABA-only treatment (O’Byrne,
NEJMed 2018)
Symptoms reduced; one study showed reduced
exercise-induced bronchoconstriction.

Step 2 - two ‘preferred’ controller options
(2) As-needed low dose ICS-formoterol
High importance was given to preventing severe
exacerbations, avoiding need for daily ICS in patients with
mild or infrequent symptoms, and safety of as-needed ICS-
formoterol in maintenance and reliever therapy, with no
new safety signals
Lower importance given to small non-cumulative differences
in symptom control (ACQ-5 difference 0.15 vs MCID 0.5) and
lung function compared with daily ICS
Makes use of normal patient behavior (seeking symptom
relief) to deliver controller

Step 2 - other controller options
Low dose ICS taken whenever SABA taken
(off-label, separate or combination inhalers)
Evidence
Two RCTs showed reduced exacerbations compared
with SABA-only treatment
BEST, in adults, with combination ICS-SABA (Papi, NEJMed 2007)
TREXA, in children/adolescents, with separate inhalers (Martinez,
Lancet 2011)
Three RCTs showed similar or fewer exacerbations
compared with maintenance ICS
TREXA, BEST
BASALT in adults, separate inhalers, vs physician-adjusted
treatment (Calhoun, JAMA 2012)

Step 2 - other controller options
Low dose ICS taken whenever SABA taken
(off-label, separate or combination inhalers)
High importance given to preventing severe exacerbations
Lower importance given to small differences in symptom
control and the inconvenience of needing to carry two
inhalers
Combination ICS-SABA inhalers are available in some
countries, but approved only for maintenance use
Another option: Leukotriene receptor antagonist
(less effective for exacerbations)

Other changes in GINA 2019
Steps 3-5
for adults and adolescents

PREFERRED
CONTROLLER
PREFERRED
RELIEVER
Other
reliever option
STEP 1
As-needed
low dose
ICS-formoterol *
Low dose ICS
taken whenever
SABA is taken†
STEP 2
STEP 3
Low dose
ICS-LABA
Medium dose
ICS, or
low dose
ICS+LTRA #
STEP 4
Medium dose
ICS-LABA
High dose
ICS, add-on
tiotropium,
or add-on
LTRA #
STEP 5
High dose
ICS-LABA
Refer for
phenotypic
assessment
± add-on
therapy,
e.g.tiotropium,
anti-IgE,
anti-IL5/5R,
anti-IL4R
Add low dose
OCS, but
consider
side-effects
Other
Controller option
There is no theophylline

PREFERRED
CONTROLLER
PREFERRED
RELIEVER
Other
reliever option
STEP 1
As-needed
low dose
ICS-formoterol *
Low dose ICS
taken whenever
SABA is taken†
STEP 2
STEP 3
Low dose
ICS-LABA
Medium dose
ICS, or
low dose
ICS+LTRA #
STEP 4
Medium dose
ICS-LABA
High dose
ICS, add-on
tiotropium,
or add-on
LTRA #
STEP 5
High dose
ICS-LABA
Refer for
phenotypic
assessment
± add-on
therapy,
e.g.tiotropium,
anti-IgE,
anti-IL5/5R,
anti-IL4R
Add low dose
OCS, but
consider
side-effects
Other
Controller option
Step 4 treatment is
medium dose ICS-LABA;
high dose now in Step 5

PREFERRED
CONTROLLER
PREFERRED
RELIEVER
Other
reliever option
STEP 1
As-needed
low dose
ICS-formoterol *
Low dose ICS
taken whenever
SABA is taken†
STEP 2
STEP 3
Low dose
ICS-LABA
Medium dose
ICS, or
low dose
ICS+LTRA #
STEP 4
Medium dose
ICS-LABA
High dose
ICS, add-on
tiotropium,
or add-on
LTRA #
STEP 5
High dose
ICS-LABA
Refer for
phenotypic
assessment
± add-on
therapy,
e.g.tiotropium,
anti-IgE,
anti-IL5/5R,
anti-IL4R
Add low dose
OCS, but
consider
side-effects
Other
Controller option
High dose ICS-LABA
Anti-IL 5R
Anti-IL 4R

Management of asthma
exacerbations

Management of asthma exacerbations in primary care

Mild or Moderate Severe or Life threatening

Management of asthma exacerbations in acute care facility

Uncontrolled Asthma
• Poor symptoms control (frequent symptoms or
reliever use, activity limited by asthma, night
waking due to asthma)
And / Or
• Frequent exacerbation ( >2 per year) requiring
oral corticosteroids or serious exacerbation ( >1
per year ) requiring hospitalization.

Difficult-to-treat asthma
Asthma that is uncontrolled despite GINA Step
4 or 5 treatment or that requires such
treatment to maintain good symptom control
and reduce the risk of exacerbations.
Contributory factors may include incorrect
diagnosis, incorrect inhaler technique, poor
adherence, comorbidities.

Severe asthma
Severe asthma is 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.
It is sometimes called ‘severe refractory asthma’
since it is relatively refractory to high dose inhaled
therapy.
However, with the advent of biologic therapies,
the word ‘refractory’ is no longer appropriate.

What proportion of adults have
difficult-to-treat or severe asthma

Management of
difficult-to-treat
and severe asthma

Asthma with Pregnancy
Asthma control often changes during pregnancy.
For baby and mother, the advantages of actively
treating asthma markedly outweigh any potential
risks of usual controller and reliever medications.
Down-titration has a low priority in pregnancy.
Exacerbations should be treated aggressively.

Surgical Procedure in Asthma patient
Whenever possible, good asthma control should be
achieved preoperatively.
Ensure that controller therapy is maintained
throughout the perioperative period.
Patients on long-term high dose ICS, or having more
than 2 weeks’ OCS in the past 6 months, should
receive intra-operative hydrocortisone to reduce the
risk of adrenal crisis.

Take home message
No longer recommends starting with SABA
only treatment.
All adults and adolescents with asthma
should receive ICS-containing controller
treatment, to reduce their risk of serious
exacerbations and to control symptoms.

GINA 2019 presentation

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Editor's Notes