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 BasheerDTQM, CPHQ, Lean Six Sigma YB,

Team STEPPS Master TrainerMCs 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 NoB. 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 assessmentASSESS 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

DiagnosisSymptom control & risk factors(including lung function)Inhaler technique & adherencePatient preference

Asthma medicationsNon-pharmacological strategiesTreat modifiable risk factors

SymptomsExacerbationsSide-effectsPatient satisfactionLung 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 2STEP 3

STEP 4

STEP 5

Low dose ICS

Consider low dose ICS

Leukotriene receptor antagonists (LTRA)Low dose theophylline*

Med/high dose ICSLow 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 ICSLow 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

Health & Medicine