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56, 2014
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Director/Editor-in-Chief
SPECIAL ISSUE
Guidelines for
Diagnosis and Management
of
Chronic Obstructive Pulmonary Disease
Joint Recommendations of
Indian Chest Society
and
National College of Chest Physicians (India)
2014;Vol.56
Founded by
Professor R. Viswanathan
Founder-Director,
Vallabhbhai Patel Chest Institute
Editor-in-Chief
Rajendra Prasad, Delhi
Editors
S.K. Jindal, Chandigarh
Ashok Shah, Delhi
S.K. Sharma, New Delhi
Alladi Mohan, Tirupati
S.K. Chhabra, Delhi
Associate Editors
Dheeraj Gupta, Chandigarh
J.M. Joshi, Mumbai
J.C. Suri, New Delhi
Journal Coordinators
R.K. Gupta, Delhi
D.K. Sahu, Delhi
Editorial Board
R. Agarwal, Chandigarh
A.N. Aggarwal, Chandigarh
G. Ahluwalia, Ludhiana
J.N. Banavaliker, Delhi
R.S. Bedi, Patiala
D. Behera, New Delhi
Kazi S. Bennoor, Bangladesh
Arati Bhatia, Delhi
Narendra Bhatta, Nepal
Mridula Bose, Delhi
Dhruva Chaudhry, Rohtak
P.N. Chhajed, Mumbai
Anuradha Chowdhary, Delhi
D.J. Christopher, Vellore
Brian H. Davies, UK
R.K. Dewan, New Delhi
2014;Vol.56
Vice-President (2014-2016)
Dr Vikram Kumar Jain
Jaipur
President-Elect (2015-2016)
Dr Narayan Mishra
Odisha
Secretary (2013-2016)
Dr S.N. Gaur
Delhi
Treasurer (2012-2015)
Dr V.K. Singh
Delhi
Councillors (2013-2015)
Dr Rajendra Prasad
Delhi
Dr V.K. Jain
Jaipur
Dr Surya Kant
Lucknow
Councillors (2014-2016)
Dr K.B. Gupta
Rohtak
Dr Bharat Gopal
New Delhi
Dr K. Bhupendra Meghwal
Jaipur
Zonal Chairmen
North
Dr J.C. Suri
New Delhi
South
Dr P. Ravindran
Trivandrum
Central
Dr S.K. Katiyar
Kanpur
East
Dr Narayan Mishra
Ganjam, Odisha
Dr Santosh Kumar
Agra
West
Dr N.K. Jain
Jaipur
D. Dadhwal, Chandigarh
Note: These guidelines are being published simultaneously in Lung India and The Indian Journal of Chest Diseases and Allied
Sciences (Official periodicals of ICS and V.P. Chest Institute and NCCP (India), respectively).
Correspondence and reprint requests: Dr Dheeraj Gupta, Professor, Department of Pulmonary Medicine, Postgraduate
Institute of Medical Education and Research (PGIMER), Chandigarh - 160 012, India; Phone: 91-172-2756823; Fax: 91-172-2748215;
E-mail: dheeraj1910@gmail.com
SYNOPSIS OF RECOMMENDATIONS
Chronic obstructive pulmonary disease (COPD) is a
common, preventable lung disorder characterised by
progressive, poorly reversible airflow limitation often
with systemic manifestations, in response to tobacco
smoke and/or other harmful inhalational exposures.
As of now valid spirometry-based nationwide
prevalence data for COPD in India are not available.
In most of the critical analyses, validated
questionnaire-based data has been accepted as
reasonable for the assessment of prevalence of COPD
despite its limitations. COPD poses enormous burden
in terms of morbidity and mortality globally and in
India. COPD poses a huge economic burden in terms
of direct and indirect costs.
The Indian Chest Society and the National College
of Chest Physicians (India) have joined hands to
come out with these evidence-based guidelines to
help the physicians at all levels of healthcare to
diagnose and manage COPD in a scientific manner.
The modified grade system was used for
classifying the quality of evidence as 1, 2, 3 or usual
practice point (UPP) (Table 1). The strength of
recommendation was graded as A or B depending
upon the level of evidence (Table 1).
7.
2.
3.
Table 1. Classification of level of evidence and grading of recommendation based on the quality of evidence supporting the recommendation
Classification of Level of Evidence
Level l
High-quality evidence backed by consistent results from well-performed randomised controlled trials, or
overwhelming evidence from well-executed observational studies with strong effects
Level 2
Moderate-quality evidence from randomised trials (that suffer from flaws in conduct, inconsistency, indirectness,
imprecise estimates, reporting bias, or other limitations)
Level 3
Low-quality evidence from observational evidence or from controlled trials with several serious limitations
Useful Practice
Point
Not backed by sufficient evidence; however, a consensus reached by working group, based on clinical experience
and expertise
Strong recommendations to do (or not to do) where the benefits clearly outweigh the risk (or vice versa) for most, if
not all patients
Grade B
Weaker recommendations where benefits and risk are more closely balanced or are more certain
3.
4.
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6.
3.
2014;Vol.56
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Severity*
Post-bronchodilator FEV1,
%predicted
mMRC
Grade
Exacerbation
Frequency
Complications
Mild
>80%
<2
<2
No
Moderate
50%-79%
>2
<2
No
Severe
<50%
>2
>2
Yes
*The category with the worst value should be used for severity classification
Number of exacerbations in the last year
Complications include respiratory failure (defined by PO2 <60mmHg and/
or SpO2 <88% and/or PCO2 >50mmHg), cor-pulmonale, and secondary
polycythaemia (haematocrit >55%)
FEV 1=Forced expiratory volume in the first second; mMRC=Modified
Medical Research Council Questionnaire; PO2=Partial pressure of arterial
oxygen; SpO 2=Oxygen saturation of haemoglobin on pulse oximetry;
PCO2=Partial pessure of carbon dioxide
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Initial Therapy
Add-on Therapy
First choice
Alternative choice
Mild
Methylxanthines
Moderate
LAMA
LABA
Severe
LAMA
SABA (salbutamol or levosalbutamol) or SAMA (ipratropium) are to be used as reliever therapy for all patients as and when needed
COPD=Chronic obstructive pulmonary disease; SABA=Short-acting beta-agonists; SAMA=Short-acting antimuscarinic agent,
LAMA=Long-acting antimuscarinic agent, LABA=Long-acting beta-agonist; ICS=Inhaled corticosteroids
2014;Vol.56
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3.
4.
5.
6.
7.
8.
Others
Presence of severe comorbid conditions
Lack of social support
Pulse oximetry
SpO 2 <90%
* Presence of any of these qualifies a patient with need for
admission. The ultimate decision to admit depends on the
overall clinical assessment of the physician.
COPD=Chronic obstructive pulmonary disease; SpO2=Pulsatile
oxygen saturation
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Web Address
ISSN No.
Language
Periodicity
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2014;Vol.56
13
INTRODUCTION
COPD is a common, preventable lung disorder
characterised by progressive, poorly reversible
airflow limitation often with systemic manifestations, in response to tobacco smoke and/or
other harmful inhalational exposures. As of now
valid spirometry- based nation-wide prevalence
data for COPD in India are not available. In most of
the critical analyses, validated questionnaire-based
data has been accepted as reasonable for the
assessment of prevalence of COPD despite its
limitations. COPD poses enormous burden in terms
of morbidity and mortality globally and in India.
COPD poses a huge economic burden in terms of
direct and indirect costs.
METHODOLOGY
The process of development of guidelines for
diagnosis and management of patients of chronic
obstructive pulmonary disease (COPD) in India was
undertaken as a joint exercise of the two National
14
2014;Vol.56
Tobacco Smoking
Non-communicable diseases (NCDs) account for
approximately 36 million deaths per year across the
globe; among them tobacco alone causes
approximately 6 million deaths and is the leading
modifiable risk factor for NCDs.28,29
Tobacco is abused in two main forms, mainly
smoking and smokeless tobacco. Globally, the rate of
current smokers is estimated to be about 1 billion.29 In
the INSEARCH study, the prevalence of tobacco use
was 28.5% and 2.1%, respectively among adult males
and females.18 According to the Global Adult Tobacco
Survey (2009-2010) conducted in India, the
prevalence of tobacco use in any form was 34.6%
(47.9% and 20.3% among males and females
respectively). Of them, 14% (24.3% males and 2.9%
females) smoked tobacco. The rise in COPD incidence
has paralleled the rise in tobacco smoking
throughout the world. 30, 31 There is a strong doseresponse relationship (for amount and duration)
15
Probable
Tobacco smoking
Pulmonary tuberculosis
Occupational exposure
Alpha-1-antitrypsin deficiency
Poor nourishment
Repeated lower respiratory infections during childhood
Others
Age
Male gender
Low socio-economic status
16
Occupational Exposures
A systematic review of epidemiological data by the
American Thoracic Society suggests that about 15% of
COPD cases might be related to exposure at
workplace.48 In subsequent studies, the proportion of
patients with COPD attributable to occupation was
about 19% overall and 31% in never smokers. 49 The
list of occupations associated with increased risk of
COPD include rubber, plastic and leather
manufacturing, textile mill product manufacturing
and food product manufacturing.50
Pulmonary Tuberculosis
The association of pulmonary tuberculosis (PTB)
with COPD has occasionally been described. The
prevalence of airflow obstruction varies from 28% to
68% of patients with treated PTB.56 In a nation-wide
survey of 13,826 adults in South Africa, a history of
PTB was associated with COPD with odds of 4.9 for
males and 6.6 for females. 57 Whether this finding of
obstructive functional defect in post-tubercular sequel
behaves as COPD, or is different, remains to be
established in long-term prospective cohort studies.
Asthma
Patients with active asthma were found to have
10-fold increased risk of chronic bronchitis and
17-fold increased risk of emphysema as compared to
those without asthma, even after adjustment for
confounding factors. 58 A subsequent review 59 also
suggests that a subset of patients with asthma may
have COPD phenotype.
Miscellaneous Factors
An increased association of COPD is reported with
demographic and socio-economic factors, such as
advancing age, low socio-economic status and urban
residence with lower socio-economic status. This
association may perhaps be attributed to the greater
prevalence of smoking and cumulative effects of
smoking and other exposures with age. Low socioeconomic status and infections have been listed as
additional risks.
2014;Vol.56
Recommendations
1.
2.
3.
4.
17
Breathlessness
Patients may variously describe their breathlessness
as: my breathing requires effort, I cannot get
enough air in, I feel out of breath or I feel hunger
for more air.63 There may be individual and cultural
variations in the description of breathlessness. 64
Breathlessness is usually present on exertion until
late in the course of the disease. Orthopnoea occurs
early and more commonly in heart failure, which is
an important differential diagnosis, while it is
reported infrequently and late (if ever) in patients
with COPD. The severity of breathlessness may be
graded on various scales. A simple and widely used
scale is the modified Medical Research Council
(mMRC) questionnaire65 (illustrated in Table 6).
Grade
Grade 0
Grade 1
Grade 2
Grade 3
Grade 4
Recommendation
18
Wheezing
Patients may complain of wheezing, variously
described as noisy breathing or a whistling sound.
Wheezing may have diagnostic value when seen in
the light of other clinical features.60-62
Chest Tightness
Patients may complain of chest tightness, chest
congestion or an obstructed chest.
Recommendations
1.
2.
2014;Vol.56
19
20
Recommendations
1.
2.
3.
4.
Recommendation
Absence of bronchodilator reversibility does not
differentiate COPD from asthma, and its presence
does not predict the response to treatment. (1A)
However, all FEV 1 values should be reported postbronchodilator.
Recommendation
Spirometry is not recommended as a screening tool in
asymptomatic individuals to detect airflow obstruction.
(2A)
2014;Vol.56
Recommendation
Peak expiratory flow should not be routinely used for
screening, diagnosis or monitoring in COPD. (1A)
21
Recommendations
1.
2.
Pulse Oximetry
Pulse oximetry can serve as a screening test for
systemic hypoxaemia during acute exacerbation of
COPD, as well in patients with chronic respiratory
failure. Studies have shown that a cut-off of 88%-92%
has an almost 100% sensitivity to predict hypoxaemia
during exacerbations.139, 140
Chest Radiography
The radiological abnormalities associated with COPD
are non-specific. Moreover, the sensitivity of chest
radiography for the diagnosis of COPD is poor.141-143 It
is useful to exclude alternative diagnoses, and to
identify other comorbidities and/or complications.144
22
Recommendations
1.
2.
3.
4.
5.
6.
7.
8.
Recommendation
Composite scores including BODE and DOSE should not
be used to assess severity or prognosis in COPD unless they
are validated in Indian patients. (2A)
Recommendation
Patients with COPD should be routinely evaluated, and
appropriately treated for comorbid conditions. (2A)
2014;Vol.56
23
Recommended Dose
Inhaled Agents *
Anticholinergics
Short acting
Ipratropium bromide
20-40 g as needed
Long acting
Tiotropium
18 g once daily
Beta-agonists
Short acting
Salbutamol
Levosalbutamol
Terbutaline
100-200 g as needed
45-90 g as needed
250-500 g as needed
Long-acting
Salmeterol
Formoterol
Indacaterol
Corticosteroids
Fluticasone
Budesonide
Beclomethasone
Ciclesonide
Mometasone
Oral Agents
Beta-agonists
Salbutamol
Bambuterol
Terbutaline
Methylxanthines
Sustained release theophylline
Doxophylline
24
Table 12. Correct technique for using pressurised metered dose inhaler
Steps for Using Pressurised Metered Dose Inhaler
1.
Sit up straight, and remove inhaler cap
2.
Hold inhaler upright by placing index finger on top of the canister while providing support on the bottom of the device with the
thumb, and shake well
3.
Take a few deep breaths and breathe out gently away from the device
4.
Put mouth-piece between teeth without biting and close lips to form good seal, keeping the tongue relaxed and not blocking the
mouth-piece
5.
Start breathing in slowly through mouth, and simultaneously press down firmly on canister with the index finger, once only, to
release one puff of medicine
6.
Continue to breathe in slowly, evenly and deeply over 5-7 seconds, till the lungs seem completely filled
7.
Hold breath for about 10 seconds, or as long as comfortable
8.
While holding breath, remove inhaler from mouth
9.
Breathe out slowly away from the device, and then inhale normally
10. If an extra dose is needed, wait 30 seconds to a minute, and then repeat steps 2 to 9
11. Replace inhaler cap
Steps for Using Pressurised Metered Dose Inhaler with a Spacer Device
1.
Sit up straight, and assemble spacer device
2.
Remove inhaler cap
3.
Hold inhaler upright by placing index finger on top of the canister while providing support on the bottom of the device with the
thumb, and shake well
4.
Insert inhaler upright into spacer
5.
Put mouth-piece between teeth without biting and close lips to form good seal, keeping the tongue relaxed and not blocking the
mouth-piece
6.
Take a few deep breaths and breathe out gently away from the device
7.
Hold spacer horizontally at level of mouth, and press down firmly on canister with the index finger, once only, to release one puff
of medicine
8.
Breathe in slowly, evenly and deeply, till the lungs seem completely filled, and then hold breath for about 10 seconds or as long
as comfortable OR breathe in and out normally for four breaths
9.
Remove spacer from mouth
10. Breathe out gently away from the device, and then inhale normally
11. Remove inhaler from spacer
12. If an extra dose is needed, wait 30 seconds to a minute, and then repeat steps 3 to 11
13. Replace inhaler cap and disassemble spacer device
2014;Vol.56
25
Prior to the introduction of tiotropium bromide, shortacting ipratropium was widely used for the
management of stable COPD. Only a few short-term,
randomised, controlled trials have compared
ipratropium versus placebo. 103,185-187 These studies
showed a consistent improvement in lung function and
dyspnoea scores in patients using ipratropium. None of
these studies assessed exacerbation and mortality rates.
No long-term studies have assessed regular ipratropium
use in patients having stable COPD.
26
Recommendations
1.
2.
3.
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2014;Vol.56
Does the Risk Benefit Ratio of Inhaled Betaagonists Favour Their Use in the Management of
COPD?
Inhaled beta-agonists often lead to some common
adverse events like tremors and palpitations,
especially in high doses. These have also been shown
to cause transient hypoxaemia due to their
vasodilatory effects on pulmonary vasculature which
worsens ventilation-perfusion mismatch in areas of
poor ventilation. 218 A single dose of beta-agonist
increased the heart rate by 9 beats per minute, and
decreased serum potassium concentration by 0.36
mmol/L. 219 In the same meta-analysis it was also
shown that long-term use of beta-agonists was
associated with sinus tachycardia (OR 3.06) and an
increase in major cardiovascular events (OR 2.54). A
large retrospective cohort study220 of 76,661 patients
has also shown that current use of SABAs or LABAs
increases the risk of arrhythmias. In the Candesartan
in Heart Failure: Assessment of Reduction in Mortality
and Morbidity (CHARM) programme, a large
prospective observational study 221 of patients with
heart failure, use of bronchodilators was associated
with poor survival. Another meta-analysis comparing
the effects of beta-agonists and anticholinergics to
placebo concluded that anticholinergics (but not betaagonists) decrease the risk of COPD exacerbation, and
that beta-agonists actually increase respiratory
mortality.222 The large TORCH study did not show any
increase in risk of cardiovascular adverse events with
the use of salmeterol monotherapy.223 A recent metaanalysis,208 that included the results of TORCH study,
concluded that use of LABAs monotherapy decreases
exacer-bations, and that there was no increase in
cardio-vascular or respiratory mortality as previously
suggested.
Recommendations
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2014;Vol.56
Recommendation
Routine use of mucolytic agents is not recommended in
patients with COPD. (2A)
31
32
Environmental Factors
Air pollution
Haemophilus influenzae
Cold air
Streptococcus pneumoniae
Allergens
Moraxella catarrhalis
Tobacco smoking
2014;Vol.56
Recommendations
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3.
33
Recommendation
The decision to admit the patient can be made on the
basis of level of severity as shown in table 2 while BAP-65 score
may help in deciding patients who need management in an
intensive care unit (Figure). (2A)
34
Recommendations
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2014;Vol.56
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Recommendations
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3.
4-6 mL/Kg
Respiratory rate
8-12/minute
PEEP
5-8 cmH 2 O
1:3-1:6
Flow waveform
Square waveform
Goals
Plateau pressure
30 cmH 2 O
PaO 2
55-60 mmHg
pH
Modified from GOLD guidelines
7.2-7.4
8
Recommendations
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2.
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2014;Vol.56
NON-PHARMACOLOGICAL
MANAGEMENT OF COPD
Should Smoking Cessation be Advised?
What are the Methods of Smoking Cessation?
Smoking cessation is without doubt the most effective
method to prevent COPD. 361 This has been
established by a number of studies over the last
several decades, and is recommended by all major
guidelines.7,8 In addition to a reduction in the rate of
decline of FEV1 in stable COPD, smoking cessation is
also associated with reduction in the frequency of
exacerbations.362 Standard guidelines (Table 17) are
available to both physicians and patients for quitting
smoking; guidelines have also been made available
by the National Tobacco Control Programme under
the Ministry of Health and Family Welfare in
India.361, 363, 364
A variety of pharmacotherapies have also become
available. These include:
Nicotine replacement therapies: act by the
supplementation of nicotine during the period of
abstinence and help to reduce withdrawal symptoms.
Various forms are available including gums, tablets,
patches and inhalers. Use of nicotine replacement
therapies has been shown to increase the quit rate by
50%-70% compared to placebo. 365
Bupropion: acts by inhibiting the reuptake of both
dopamine and norepinephrine in the brain;
antagonism of the nicotine receptor has also been
demonstrated.366There are higher odds (OR 2.12) for
quitting smoking with the use of bupropion as
compared to placebo.367
Varenicline: is a partial agonist of the alpha4beta2
nicotinic receptor. It has a dual mechanism of action.
It is both a partial agonist of the nicotinic receptor
(wherein it provides some amount of stimulation) as
well as simultaneously blocks the effect of nicotine on
the receptor in case the patient smokers. 366 A metaanalysis 367 of 69 trials showed that varenicline had
the highest odds (2.55; 95% CI, 1.99-3.24) of smoking
cessation out of all the available pharmacotherapies.
There is no fixed protocol on the use of these
agents. However, pharmacotherapy should be offered
to all patients in view of the significantly increased
quit rates with these modalities. The quit rate is even
better if intensive counselling sessions are combined
with pharmacotherapy.365, 368-370
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Recommendations
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Recommendation
Bronchoscopic techniques are upcoming modalities
of treatment; the data are too sparse to make an
evidence-based recommendation.
42
Recommendations
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Recommendations
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Recommendation
Antibiotics should not be prescribed as a routine for
the prevention of exacerbations of COPD. (2A)
2014;Vol.56
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9.
10.
Recommendation
Patients with severe COPD and those on long-term
oxygen therapy should be assessed before air travel by
a specialist. (UPP)
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