Updates in pulmonary medicine 2017

© Global Initiative for Asthma3.
GINA Global Strategy for Asthma Management
and Prevention
GOLD Global Strategy for Diagnosis,
Management and Prevention of COPD
What’s new in GINA and GOLD
2017
Dr Ahmed Basheer
DTQM, CPHQ, Lean Six Sigma YB,
Team STEPPS Master Trainer
MCs of Pulmonary medicine,
TQM & IPC Director at Salamat Medical Complex

© Global Initiative for 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.
Definition of asthma
GINA 2017

Patient with
respiratory symptoms
Are the symptoms typical of asthma?
Detailed history/examination
for asthma
History/examination supports
asthma diagnosis?
Perform spirometry/PEF
with reversibility test
Results support asthma diagnosis?
Empiric treatment with
ICS and prn SABA
Review response
Diagnostic testing
within 1-3 months
Repeat on another
occasion or arrange
other tests
Confirms asthma diagnosis?
Consider trial of treatment for
most likely diagnosis, or refer
for further investigations
Further history and tests for
alternative diagnoses
Alternative diagnosis confirmed?
Treat for alternative diagnosisTreat for ASTHMA
Clinical urgency, and
other diagnoses unlikely
YES
YES
YES NO
NO
NO
NO
YES
YES
NO
© Global Initiative for AsthmaGINA 2017

 Increased probability that symptoms are due to asthma if:
 More than one type of symptom (wheeze, shortness of breath, cough,
chest tightness)
 Symptoms often worse at night or in the early morning
 Symptoms vary over time and in intensity
 Symptoms are triggered by viral infections, exercise, allergen
exposure, changes in weather, laughter, irritants such as car exhaust
fumes, smoke, or strong smells
 Decreased probability that symptoms are due to asthma if:
 Isolated cough with no other respiratory symptoms
 Chronic production of sputum
 Shortness of breath associated with dizziness, light-headedness or
peripheral tingling
 Chest pain
 Exercise-induced dyspnea with noisy inspiration (stridor)
Diagnosis of asthma – symptoms
GINA 2017

 Confirm presence of airflow limitation
 Document that FEV1/FVC is reduced (at least once, when FEV1 is low)
 FEV1/ FVC ratio is normally >0.75 – 0.80 in healthy adults, and
>0.90 in children
 Confirm variation in lung function is greater than in healthy individuals
 The greater the variation, or the more times variation is seen, the
greater probability that the diagnosis is asthma
 Excessive bronchodilator reversibility (adults: increase in FEV1 >12%
and >200mL; children: increase >12% predicted)
 Excessive diurnal variability from 1-2 weeks’ twice-daily PEF
monitoring (daily amplitude x 100/daily mean, averaged)
 Significant increase in FEV1 or PEF after 4 weeks of controller
treatment
 If initial testing is negative:
• Repeat when patient is symptomatic, or after withholding bronchodilators
• Refer for additional tests (especially children ≤5 years, or the elderly)
Diagnosis of asthma – variable airflow limitation
GINA 2017

Time (seconds)
Volume
Note: Each FEV1 represents the highest of
three reproducible measurements
Typical spirometric tracings
FEV1
1 2 3 4 5
Normal
Asthma
(after BD)
Asthma
(before BD)
Flow
Volume
Normal
Asthma
(after BD)
Asthma
(before BD)
GINA 2017

GINA assessment of symptom control
A. Symptom control
In the past 4 weeks, has the patient had:
Well-
controlled
Partly
controlled
Uncontrolled
• Daytime asthma symptoms more
than twice a week? Yes No
None of
these
1-2 of
these
3-4 of
these
• Any night waking due to asthma? Yes No
• Reliever needed for symptoms*
more than twice a week? Yes No
• Any activity limitation due to asthma? Yes No
B. Risk factors for poor asthma outcomes
• Assess risk factors at diagnosis and periodically
• Measure FEV1 at start of treatment, after 3 to 6 months of treatment to record the patient’s
personal best, then periodically for ongoing risk assessment
ASSESS PATIENT’S RISKS FOR:
• Exacerbations
• Fixed airflow limitation
• Medication side-effects
GINA 2017
Level of asthma symptom control

The control-based asthma management cycle
GINA 2017
Diagnosis
Symptom control & risk factors
(including lung function)
Inhaler technique & adherence
Patient preference
Asthma medications
Non-pharmacological strategies
Treat modifiable risk factors
Symptoms
Exacerbations
Side-effects
Patient satisfaction
Lung function

© Global Initiative for Asthma© Global Initiative for Asthma
Stepwise approach to control asthma symptoms
and reduce risk
GINA 2017, Box 3-5 (1/8)
Symptoms
Exacerbations
Side-effects
Patient satisfaction
Lung function
Other
controller
options
RELIEVER
REMEMBER
TO...
• Provide guided self-management education (self-monitoring + written action plan + regular review)
• Treat modifiable risk factors and comorbidities, e.g. smoking, obesity, anxiety
• Advise about non-pharmacological therapies and strategies, e.g. physical activity, weight loss, avoidance of
sensitizers where appropriate
• Consider stepping up if … uncontrolled symptoms, exacerbations or risks, but check diagnosis, inhaler
technique and adherence first
• Consider adding SLIT in adult HDM-sensitive patients with allergic rhinitis who have exacerbations despite
ICS treatment, provided FEV1 is >70% predicted
• Consider stepping down if … symptoms controlled for 3 months + low risk for exacerbations.
Ceasing ICS is not advised.
STEP 1 STEP 2
STEP 3
STEP 4
STEP 5
Low dose ICS
Consider low
dose ICS
Leukotriene receptor antagonists (LTRA)
Low dose theophylline*
Med/high dose ICS
Low dose ICS+LTRA
(or + theoph*)
As-needed short-acting beta2-agonist (SABA) As-needed SABA or
low dose ICS/formoterol#
Low dose
ICS/LABA**
Med/high
ICS/LABA
Diagnosis
Symptom control & risk factors
(including lung function)
Inhaler technique & adherence
Patient preference
Asthma medications
Non-pharmacological strategies
Treat modifiable risk factors
PREFERRED
CONTROLLER
CHOICE
Add tiotropium*
High dose ICS
+ LTRA
(or + theoph*)
Add low dose
OCS
Refer for
add-on
treatment
e.g.
tiotropium,*
anti-IgE,
anti-IL5*
SLIT added
as an option

Step 5 – higher level care and/or add-on
treatment
GINA 2017
Other
controller
options
RELIEVER
STEP 1 STEP 2
STEP 3
STEP 4
STEP 5
Low dose ICS
Consider low
dose ICS
Leukotriene receptor antagonists (LTRA)
Low dose theophylline*
Med/high dose ICS
Low dose ICS+LTRA
(or + theoph*)
As-needed short-acting beta2-agonist (SABA)
Low dose
ICS/LABA**
Med/high
ICS/LABA
PREFERRED
CONTROLLER
CHOICE
UPDATED!
*Not for children <12 years
**For children 6-11 years, the preferred Step 3 treatment is medium dose ICS
#For patients prescribed BDP/formoterol or BUD/ formoterol maintenance and reliever therapy
 Tiotropium by mist inhaler is an add-on treatment for patients ≥12 years with a history of exacerbations
Refer for
add-on
treatment
e.g.
tiotropium,*
omalizumab,
mepolizumab*
As-needed SABA or
low dose ICS/formoterol#
Add tiotropium*
High dose ICS
+ LTRA
(or + theoph*)
Add low
dose OCS

 Preferred option is referral for specialist investigation and consideration of
add-on treatment
 If symptoms uncontrolled or exacerbations persist despite Step 4 treatment,
check inhaler technique and adherence before referring
 Add-on tiotropium for patients ≥12 years with history of exacerbations
 Add-on omalizumab (anti-IgE) for patients with severe allergic asthma
 Add-on mepolizumab (anti-IL5) for severe eosinophilic asthma (≥12
yrs)
 Other add-on treatment options at Step 5 include:
 Sputum-guided treatment: this is available in specialized centers; reduces
exacerbations and/or corticosteroid dose
 Add-on low dose oral corticosteroids (≤7.5mg/day prednisone equivalent):
this may benefit some patients, but has significant systemic side-effects.
Assess and monitor for osteoporosis
 See ERS/ATS Severe Asthma Guidelines (Chung et al, ERJ 2014) for more
detail
Step 5 – higher level care and/or add-on
treatment
GINA 2017
UPDATED!

 Step-down from low-dose ICS (Box 3-7)
 Add-on LTRA may help
 Insufficient evidence for step-down to as-needed ICS with SABA
 Side-effects of oral corticosteroids
 When prescribing short-term OCS, remember to advise patients
about common side-effects (sleep disturbance, increased appetite,
reflux, mood changes); references added
 Vitamin D
 To date, no good quality evidence that Vitamin D supplementation
leads to improved asthma control or fewer exacerbations
 Chronic sinonasal disease
 Treatment with nasal corticosteroids improves sinonasal symptoms
but not asthma outcomes
Treatment – other changes in 2017
What’s new in GINA 2017?

Stepwise management, SLIT as an add-on option
for some patients
GINA 2017, Box 3-5 (3/8) (lower part)
REMEMBER
TO...
SLIT: sublingual immunotherapy
• Provide guided self-management education
• Treat modifiable risk factors and comorbidities
• Advise about non-pharmacological therapies and strategies
• Consider stepping up if … uncontrolled symptoms, exacerbations or risks,
but check diagnosis, inhaler technique and adherence first
• Consider adding SLIT in adult HDM-sensitive patients with allergic rhinitis who
have exacerbations despite ICS treatment, provided FEV1 is 70% predicted
• Consider stepping down if … symptoms controlled for 3 months
+ low risk for exacerbations. Ceasing ICS is not advised.

 Ch 2, assessment of future risk in children 6-11 yrs
 Recommended to check height at least yearly
 The reason has been added: “…as poorly-controlled asthma can
affect growth [Pedersen 2001], and growth velocity may be lower in
the first 1-2 years of ICS treatment [Loke, 2015].”
 Ch 6, assessment of future risk in children ≤5 yrs
 Advice also added about factors that should be considered if
decreased growth velocity is seen (e.g. poorly-controlled asthma,
frequent use of OCS, and poor nutrition). Consider referral
ICS and growth in children

 Ch 6, choice of controller treatment, children ≤5 yrs
 Although effects of ICS on growth velocity are seen in pre-pubertal
children in the first 1-2 years of treatment, this is not progressive or
cumulative [Kelly 2012, Loke 2015].
 The one study that examined long-term outcomes showed a
difference of only 0.7% in adult height [Kelly 2012, Loke 2015]
 Poorly-controlled asthma itself adversely affects adult height
[Pedersen 2001]
ICS and growth in children

 Cough in infancy
 Prolonged cough in infancy, and cough without cold symptoms, are
associated with later parent-reported physician-diagnosed asthma,
independent of infant wheeze [Oren 2015]
 Primary prevention of asthma
 No consistent effects of maternal dietary intake of fish or long-chain
polyunsaturated fatty acids during pregnancy on the risk of wheeze,
asthma or atopy in the child (based on RCTs and epidemiological
studies) [Best, 2016]
Other changes

 The word ‘syndrome’ has been removed from the previous term
‘asthma-COPD overlap syndrome (ACOS)’ because:
 This term was being commonly used in the respiratory community
as if it was a single disease (‘the asthma-COPD overlap syndrome’)
 There are two medically-accepted definitions of ‘syndrome’
 This distracted from the key messages for clinicians and regulators
‘Asthma-COPD overlap’

 Distinguishing asthma from COPD can be problematic,
particularly in smokers and older adults. Some patients may
have clinical features of both asthma and COPD
 The descriptive term asthma-COPD overlap (ACO) is useful to
maintain awareness by clinicians, researchers and regulators of
the needs of these patients, since most guidelines and clinical
trials are about asthma alone or COPD alone.
 However, the term asthma-COPD overlap does not describe a
single disease entity. Instead, as for asthma and COPD, it likely
includes patients with several different forms of airways disease
(phenotypes) caused by a range of different underlying
mechanisms.
Asthma-COPD overlap – new ‘Key Points’

 Frequency of measurement of lung function
 “Lung function should be assessed at diagnosis or start of
treatment; after 3–6 months of controller treatment to assess the
patient’s personal best FEV1; and periodically thereafter”
 ‘Periodically’ has been clarified
 Most adults: lung function should be recorded at least every 1-2 yrs
 More frequently in higher risk patients
 More frequently in children based on severity and clinical course
 Lung function trajectories
 Children with persistent asthma may have reduced growth in lung
function, and some are at risk of accelerated decline in lung
function in early adult life [McGeachie, NEJMed 2016]
Measurement of lung function - changes

 Diagnosis of asthma
 Additional factors that increase or decrease FENO are listed
 FENO is not helpful in ruling in or ruling out asthma as defined by GINA
 Assessment of future risk
 Elevated FENO in allergic patients has been added to the list of
independent predictors of exacerbations [Zeiger JACI 2011]
 Single measurements
 Results of FENO measurement at a single point in time should be
interpreted with caution
 Controller treatment
 Given the lack of long-term safety studies, FENO cannot be
recommended at present for deciding against treatment with ICS in
patients with a diagnosis or suspected diagnosis of asthma.
 Based on current evidence, GINA recommends treatment with low-dose
ICS for most patients with asthma, even those with infrequent
symptoms, to reduce the risk of serious exacerbations.
Fraction of exhaled nitric oxide (FENO) - changes

COPD Definition
© 2017 Global Initiative for Chronic Obstructive Lung Disease
► Chronic Obstructive Pulmonary Disease (COPD) is a
common, preventable and treatable disease that is
characterized by persistent respiratory symptoms and
airflow limitation that is due to airway and/or alveolar
abnormalities usually caused by significant exposure
to noxious particles or gases.

Diagnosis and Initial Assessment
► Symptoms of COPD
 Chronic and progressive dyspnea
 Cough
 Sputum production
 Wheezing and chest tightness
 Others – including fatigue, weight loss,
anorexia, syncope, rib fractures, ankle
swelling, depression, anxiety.

Spirometry

Classification of severity of airflow
limitation

Choice of thresholds
► COPD Assessment Test (CAT TM )
► Chronic Respiratory Questionnaire (CCQ® )
► St George’s Respiratory Questionnaire (SGRQ)
► Chronic Respiratory Questionnaire (CRQ)
► Modified Medical Research Council (mMRC) questionnaire

ABCD Assessment Tool

Alpha-1 antitrypsin deficiency (AATD)
AATD screening
► The World Health Organization recommends that all patients
with a diagnosis of COPD should be screened once especially
in areas with high AATD prevalence.
► AATD patients are typically < 45 years with panlobular basal
emphysema
► Delay in diagnosis in older AATD patients presents as more
typical distribution of emphysema (centrilobular apical).
► A low concentration (< 20% normal) is highly suggestive of
homozygous deficiency.

Treatment of Stable COPD
Pharmacologic treatment

Treatment of Stable COPD

Pharmacologic treatment algorithms
Group A
► All Group A patients should be
offered bronchodilator treatment
based on its effect on
breathlessness. This can be either
a short- or a long-acting
bronchodilator.
► This should be continued if
symptomatic benefit is
documented.

Group B
► Initial therapy should consist of a long
acting bronchodilator. Long-acting inhaled
bronchodilators are superior to short-acting
bronchodilators taken as needed i.e., pro re
nata (prn) and are therefore recommended.
► There is no evidence to recommend one
class of long-acting bronchodilators over
another for initial relief of symptoms in this
group of patients. In the individual patient,
the choice should depend on the patient’s
perception of symptom relief.
► For patients with persistent breathlessness
on monotherapy the use of two
bronchodilators is recommended.

Group B (continued)
► For patients with severe breathlessness
initial therapy with two bronchodilators may
be considered.
► If the addition of a second bronchodilator
does not improve symptoms, we suggest
the treatment could be stepped down
again to a single bronchodilator.
► Group B patients are likely to have
comorbidities that may add to their
symptomatology and impact their
prognosis, and these possibilities should
be investigated.

Group C
► Initial therapy should consist of a single
long acting bronchodilator. In two head-to
head comparisons the tested LAMA was
superior to the LABA regarding
exacerbation prevention, therefore we
recommend starting therapy with a LAMA
in this group.
► Patients with persistent exacerbations may
benefit from adding a second long acting
bronchodilator (LABA/LAMA) or using a
combination of a long acting beta2-agonist
and an inhaled corticosteroid (LABA/ICS).
As ICS increases the risk for developing
pneumonia in some patients, our primary
choice is LABA/LAMA.

Group D
► We recommend starting therapy with a
LABA/LAMA combination because:
 In studies with patient reported outcomes as the
primary endpoint LABA/LAMA combinations
showed superior results compared to the single
substances. If a single bronchodilator is chosen
as initial treatment, a LAMA is preferred for
exacerbation prevention based on comparison to
LABAs (for details see GOLD 2017 Chapter 3).
 A LABA/LAMA combination was superior to a
LABA/ICS combination in preventing
exacerbations and other patient reported
outcomes in Group D patients (for details see
GOLD 2017 Chapter 3).
 Group D patients are at higher risk of developing
pneumonia when receiving treatment with ICS.

Group D (continued)
► In some patients initial therapy with LABA/ICS
may be the first choice. These patients may
have a history and/or findings suggestive of
asthma-COPD overlap. High blood eosinophil
counts may also be considered as a parameter
to support the use of ICS, although this is still
under debate (for details see Chapter 2 and
Appendix).
► In patients who develop further exacerbations
on LABA/LAMA therapy we suggest two
alternative pathways:
 Escalation to LABA/LAMA/ICS. Studies are
underway comparing the effects of LABA/LAMA
vs. LABA/LAMA/ICS for exacerbation prevention.
 Switch to LABA/ICS. However, there is no
evidence that switching from LABA/LAMA to
LABA/ICS results in better exacerbation
prevention. If LABA/ICS therapy does not
positively impact exacerbations/symptoms, a
LAMA can be added.

Group D (continued)
If patients treated with LABA/LAMA/ICS still have
exacerbations the following options may be
considered:
► Add roflumilast. This may be considered in
patients with an FEV1 < 50% predicted and
chronic bronchitis,13 particularly if they have
experienced at least one hospitalization for an
exacerbation in the previous year.
► Add a macrolide. The best available evidence
exists for the use of azithromycin. Consideration
to the development of resistant organisms
should be factored into decision making.
► Stopping ICS. A reported lack of efficacy, an
elevated risk of adverse effects (including
pneumonia) and evidence showing no
significant harm from withdrawal supports this
recommendation (see Chapter 3 for further
details).

Non-Pharmacologic Treatment

Non-Pharmacologic Treatment
Interventional bronchoscopy and surgery
►In selected patients with heterogeneous or homogenous
emphysema and significant hyperinflation refractory to
optimized medical care, surgical or bronchoscopic modes
of lung volume reduction (e.g., endobronchial one-way
valves or lung coils) may be considered.
►In selected patients with a large bulla, surgical bullectomy
may be considered.
►In selected patients with very severe COPD and without
relevant contraindications, lung transplantation may be
considered.

Non-Pharmacologic Treatment -
Summary

Management of Exacerbations
- Summary

Updates in pulmonary medicine 2017

Updates in pulmonary medicine 2017

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