Registry of COPD Patients Who Undergo Outpatient Treatment or Are Under Surveillance at Outpatient Polyclinic Healthcare Institutions of the Russian Federation in Moscow
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Interregional Public Organization, Russian Respiratory Society

 
 
  
Observational multicenter study 
 
Number/code 
 
 
Version 
3.0 
 
Date  
March 2018 
 
 
 
 
 
 
 
 
 
 
 
 
Registry of COPD patients who undergo outpatient treatment or are under
surveillance at outpatient polyclinic healthcare institutions of the Russian 
Federation in Moscow 
 
 
 

 
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2(30) 
 
PROTOCOL SYNOPSIS 
 
Registry of COPD patients who undergo outpatient treatment or are under 
surveillance at outpatient polyclinic healthcare institutions of the Russian 
Federation in Moscow 
 
Principal investigator: 
Belevskiy Andrey Stanislavovich, Doctor of Medicine, Professor, Head of laboratory, FSI 
«SRI of Pulmonology» of FMBA of Russia. 
Sites, number of participants 
 
At least (2000) patients at approximately 15 polyclinic sites in Moscow.  
Investigators: pulmonologists of outpatient polyclinic care in Moscow 
 
It is planned to enrol approximately 120 patients with diagnosed COPD at each of 
approximately 15 polyclinic institutions of Moscow (in total at least 2000 patients) 
 
Study period 
 
Planned study timeframes 
 
Planned timeline for enrolment of first patient 
Fourth quarter 2016 
Planned timeline for enrolment of last patient 
Second quarter 2018 
Planned timeline for last patient out 
Third quarter 2018 
Planned timeline for database lock 
Fourth quarter 2018 
Planned timeline for final report preparation 
First quarter 2019 
Planned timeline for publication of results 
Third quarter 2019 
 
Medicinal product (name, dose, administration route) and concomitant therapy 
Not applicable. 
Background 
Experts of the World Health Organization (WHO) estimated that approximately 210 mln. 
people worldwide suffer from COPD. In our modern age, COPD represents one of the leading 

 
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chronic diseases alongside with arterial hypertension, coronary heart disease and diabetes 
mellitus. They account for more than 30% among other human pathologies. COPD ranks 
fourth among causes of death worldwide, and is assumed to ascend to the third place by2020. 
According to estimations using epidemiological markers, in the Russian Federation there are 
approximately 11 mln. people suffering from COPD. Whereas according to official statistics 
their total number in the Russian Federation amounts to only 2.4 mln. This is due to 
underdiagnosis and patients seeking medical attention too late, which result in detection of the 
disease at advanced stages when even the most modern treatment methods cannot delay steady 
progression of the disease. [1] 
In the Russian Federation, diagnosis and treatment of COPD patients is performed primarily at 
community-based primary care outpatient polyclinic institutions. Every year in the Russian 
Federation there are approximately 100 thousands new cases of the disease diagnosed 
(statistics digest "Morbidity rates in adult population of Russia in 2012"). However, as a rule, 
COPD is diagnosed at advanced stages when complaints become a major problem for the 
patient. In many regions of the country, spirometric testing have still not been introduced into 
routine practice of primary care physicians, although on the positive side, in the recent years 
facilities of primary care outpatient polyclinic institutions have improved substantially. 
In 2012 there were 2.7 mln. of COPD patients under surveillance at outpatient polyclinic 
institutions in the Russian Federation. However, we do not have at our disposal updated 
information regarding the prevalence of the disease in specific cities, distribution of these 
COPD patients by extent of airway obstruction. Data on pharmacotherapy are only 
approximate. 
In developed countries, total economy expenses associated with COPD take 2nd place in the 
structure of pulmonary diseases after lung cancer, and if we consider direct expenses COPD 
takes the 1st place exceeding direct expenses for bronchial asthma 1.9-fold. Economy 
expenses per patient associated with COPD 3 times exceed those for an asthma patient. Scarce 
reports of direct medical expenses in COPD show that more than 80% of resources are spent 
on inpatient care and less than 20% – on outpatient care. It has been established that 73% of 
costs are associated with 10% of patients with severe disease. The highest economic losses are 
brought about by treatment of COPD exacerbations. In Russia, the economic burden of COPD 
taking into account indirect expenses, including absenteeism (absence from work) and 
presenteeism (less effective work caused by illness), amounts to 24.1 bln. roubles. [2]  
Study conduction rationale 
The majority of COPD patients in the Russian Federation seek medical attention from primary 
care physicians at outpatient polyclinic institutions. Physicians of these institutions can refer a 
patient for spirometric testing or to a pulmonologist (in this case, as a general rule, spirometry 
is also performed).  
In the recent years in Europe registries of COPD patients have been created: Registry of 
COPD phenotypes in patients in Central and Eastern Europe (POPE Study- Phenotypes of 
COPD in Central and Eastern Europe) 2014-2015, Czech multicentre registry of COPD 
patients, started in 2014 (Czech Multicentre Research Database of COPD, Novotná et al. 
Czech multicenter research database of severe COPD. International Journal of Chronic 
Obstructive Pulmonary Disease 2014, 9: 1265-1274".) 

 
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Registry of COPD patients includes monitoring of the possible causes of the disease, 
prevalence of different phenotypes, assessment of disease progression, therapeutic approaches 
to disease treatment in real-life clinical practice, analysis of social and economical disease 
burden. 
It is an important clinical and economical goal to arrange a registry of COPD patients who 
undergo outpatient surveillance at polyclinic institutions of Moscow, including description of 
patient clinical profile, diagnosis flow chart, therapeutic treatment tactics using different 
groups of medicinal products, compliance of used diagnostic and therapeutic approaches with 
current Federal clinical guidelines for COPD diagnosis and treatment, evolution of COPD 
prevalence parameters, monitoring of course of the disease.  
In the absence of this information it is impossible to evaluate the quality of medical care 
provided to COPD patients in the Russian Federation or to plan any actions for treatment 
refinement. 
Therefore, the purposes of the present study result from the necessity to perform the 
following: 
a) define clinical profile of COPD patients seeking attention and/or present in outpatient 
polyclinic medical care of healthcare system of Moscow (including diagnosis and therapeutic 
treatment tactics using different therapy regimens). 
b) determine the extent of the therapy conducted and its compliance with diagnosis, disease 
severity and phenotype 
c) define the disease burden (number of outpatient visits, hospitalizations, duration of days of 
disability, disability) 
Investigation of the management of COPD patients in real-life clinical practice will enable us 
to obtain demographic and social data of the patients, study the natural history of COPD, 
perform monitoring of disease activity, evaluate the efficacy of therapy, demand for 
specialized treatment, perform pharmacoeconomic analysis, and develop standard statistical 
forms. 
It is expected that it will be possible to use the results of the present study to assess % of 
different phenotypes of the COPD patients and treatment of people suffering from COPD not 
only in Moscow, but in other regions of the Russian Federation as well. 
Study objectives 
Primary objectives: 
1. To describe the clinical profile of COPD patient who is under outpatient surveillance at 
polyclinic institutions of Moscow (including demographic data (age, gender, ethnicity, 
occupation), smoking status, disease duration, disease severity grade, distribution by 
disease phenotype, disease exacerbation rate in the setting of real-life clinical practice). 
Secondary objectives: 
1. Characterize distribution (percentage (%)) of COPD patients who seek attention from 
primary medical care physicians by severity of airway obstruction, by reversibility of 

 
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airway obstruction according to criteria described in Federal clinical guidelines for COPD 
diagnosis and treatment 2014. 
2. To determine prevalence of the different disease phenotypes among outpatients: chronic 
bronchitis phenotype, emphysema phenotype, mixed phenotype, frequent exacerbator 
phenotype, Asthma+COPD phenotype (according to criteria described in Federal clinical 
guidelines for COPD diagnosis and treatment 2014. 
3. To determine the percentage of patients with eosinophilic inflammation according to 
haematology results. 
4. To describe treatment regimens prescribed to COPD patients depending on disease 
severity grade in the setting of real-life clinical practice. 
5. To establish the percentage of medical prescriptions for treatment of COPD patients 
which comply with current Federal clinical guidelines for diagnosis and treatment of 
chronic obstructive pulmonary disease. 
6. To establish prevalence and pattern of comorbidities in COPD patients. 
7. To evaluate the disease burden based on the collected data concerning the duration of 
temporary disability, number of hospitalizations due to COPD exacerbations, number of 
outpatient visits concerning COPD patients under outpatient surveillance at polyclinic 
institutions of Moscow for three years. 
Study design 
The registry of COPD patients in fact represents non-interventional multicenter  retrospective 
study including all COPD patients included into the registry retrospectively from patients 
medical records and newly diagnosed under outpatient surveillance at the selected polyclinic 
institutions of Moscow.  
The registry will include all patients with registered diagnoses J40 - J44 according to ICD-10 
with spirometry results confirming COPD diagnosis, who are at the study start under 
outpatient surveillance, and also newly registered patients diagnosed with COPD (ICD-10 J40 
- J44, as confirmed by spirometry results) during the conduction of the registry program at the 
selected polyclinic institutions of Moscow (according to ICD: J40 - Bronchitis, not specified 
as acute or chronic, J41 - Simple and mucopurulent chronic bronchitis, J41.0 - Simple chronic 
bronchitis, J41.8 - Mixed simple and mucopurulent chronic bronchitis, J 42 - Unspecified 
chronic bronchitis, J 43 - Emphysema, J 44 - Other chronic obstructive pulmonary disease) 
based on regular (yearly) retrospective analysis of patient records with data entry into a 
consolidated database. 
It is planned to enrol into the study approximately 2000 male and female patients over 40 
years of age with diagnosed COPD (as confirmed by spirometry results). 
The present observational multicenter descriptive study will be conducted in the setting of 
routine clinical practice of outpatient polyclinic institutions. There is no hypothesis to be 
tested in this study.  

 
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The study will be conducted in outpatient polyclinic institutions of the primary medical care 
system of Moscow. Pulmonologists of the primary medical care system will be engaged as 
investigators. These are the physicians, whom the patients with tentative COPD diagnosis are 
referred to in the Russian Federation and who within the scope of their responsibilities have 
access to source medical records and who evaluate the quality of diagnosis and extent of 
treatment prescribed to COPD patients.  
The present study is observational therefore it does not require a treatment regimen or 
directions for patient management. The patients receive medical care in line with routine 
practice for treatment of this disease in the Russian Federation. Patient participation in the 
study should not in any way affect the principles and extent of treatment received by the 
patient according to routine clinical practice. 
Physicians-investigators will enter into the study the information (data) concerning COPD 
patients, both those already registered at the selected medical treatment and preventive care 
institution, and newly registered patients as they seek attention at the outpatient polyclinic 
institutions. 
The main purpose of the present study consists in collection of data concerning COPD 
patients who under surveillance at outpatient polyclinic institutions of Moscow using patient 
medical records and their medical history. This protocol does not specify any obligatory visits 
or examinations. 
Patient data will be entered into the registry de-identified. The patients will be identified by 
their screening number and initials. Then the Physician-investigator will evaluate patient 
compliance with inclusion criteria. The study will enrol patients meeting all the inclusion 
criteria and not having any of the exclusion criteria.  
Only the physician who enters patient data into the regional COPD registry possesses patient 
contact information, and henceforth only this physician will enter de-identified patient data 
according to study design. This physician does not influence the choice of examination extent, 
treatment strategy and medication.  
Study variables 
Primary variables 
1. Description of the clinical profile of COPD patient under outpatient surveillance at 
polyclinic institutions of Moscow (including demographic data (age, gender, ethnicity, 
occupation), smoking status, disease duration, disease severity grade, distribution by 
disease phenotype, disease exacerbation rate in the setting of real-life clinical practice) 
Secondary variables: 
1. Percentage of patients with different disease phenotypes among outpatients 
2. Percentage of prescriptions of medicinal products to COPD patients depending on 
disease severity grade in the setting of real-life clinical practice 

 
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3. Distribution (%) of COPD patients who seek attention from primary medical care 
physicians by severity of airway obstruction (according to Federal clinical guidelines 
for diagnosis and treatment of COPD patients, 2014) 
4. Mean number of exacerbations requiring medical attention (outpatient prescription of 
oral corticosteroids and/or antibiotics) in the last year in COPD patients 
 
5. Mean number of hospitalizations in the last year in COPD patients 
6. Percentage of patients with eosinophilic inflammation  
7. Description of treatment regimens prescribed to COPD patients depending on disease 
severity grade in the setting of real-life clinical practice 
8. Percentage of prescriptions for treatment of COPD patients in line with the current 
Federal clinical guidelines for diagnosis and treatment of chronic obstructive 
pulmonary disease  
9. Disease burden based on the collected data concerning the duration of temporary 
disability, number of hospitalizations due to COPD exacerbations, outpatient visits 
concerning COPD during follow-up 
Statistics 
Descriptive analysis approach will be applied for analysis of the study objectives. Descriptive 
statistics will be used for analysis of the study population, baseline and clinical data.  
Descriptive statistics will include frequency tables (n, mean, median, standard deviation, 
minimum and maximum for continuous variables; n, frequency and percentage for categorical 
variables). Percentages will be evaluated together with 95% confidence intervals (in 
appropriate cases).  

 
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TABLE OF CONTENTS 
PAGE 
TITLE PAGE........................................................................................................................... 1
PROTOCOL SYNOPSIS ........................................................................................................ 2
TABLE OF CONTENTS......................................................................................................... 8
LIST OF ABBREVIATIONS................................................................................................ 11
1.
INTRODUCTION................................................................................................. 12
1.1
Background ........................................................................................................... 12
1.2
Study rationale....................................................................................................... 13
2.
STUDY OBJECTIVES......................................................................................... 14
2.1.
Primary study objective......................................................................................... 14
2.2.
Secondary objectives............................................................................................. 14
3.
STUDY PLAN AND PROCEDURES ................................................................. 15
4.
PATIENT POPULATION .................................................................................... 17
4.1
Physicians-investigators........................................................................................ 17
4.2
Selection criteria for COPD patients..................................................................... 18
4.2.1
Inclusion criteria for patients with diagnosed COPD............................................ 18
4.2.2
Exclusion criteria for patients with COPD risk factors and for patients with 
previously diagnosed COPD ................................................................................. 18
5.
PATIENT WITHDRAWAL FROM THE STUDY.............................................. 18
5.1
Withdrawal criteria................................................................................................ 18
5.2
Procedures for patient withdrawal from the study ................................................ 18
6.
PATIENT TREATMENT..................................................................................... 19
6.1
Treatment strategy in observational studies.......................................................... 19
7.
STUDY CONDUCTION ...................................................................................... 19
7.1
Description of the visits......................................................................................... 19
8.
PARAMETERS COLLECTED FOR STUDY, ASSESSMENT AND 
REGISTRATION METHODS ............................................................................. 20
8.1
Primary endpoints ................................................................................................. 20
8.2
Secondary endpoints ............................................................................................. 20
8.3
Economic health assessment ................................................................................. 21
8.3.1
Disease burden assessment.................................................................................... 21
8.3.2
Other parameters for disease burden assessment .................................................. 21
9.
SAFETY ASSESSMENT ..................................................................................... 21
9.1
Definitions............................................................................................................. 21
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9.1.1
Definition of an adverse event (AE)...................................................................... 21
9.1.2
Definition of a serious adverse event (SAE)......................................................... 22
9.2
Non-interventional studies without specific safety assessment objectives ........... 22
9.3
Non-interventional studies with specific safety assessment objectives ................ 22
9.4
Safety data reporting ............................................................................................. 23
9.4.1
Adverse event reports............................................................................................ 23
9.4.2
Reports of unexpected adverse events during use of medicinal products for 
human use.............................................................................................................. 23
9.4.3
Registration of spontaneous reports regarding adverse events ............................. 23
10.
ETHICS................................................................................................................. 24
10.1
Committee on ethical review for clinical studies (EC) ......................................... 24
10.2
Informed consent................................................................................................... 24
10.3
Patient data confidentiality.................................................................................... 24
10.4
Training for physicians.......................................................................................... 24
10.5
Study timeframes and completion timelines ......................................................... 25
11.
DATA MANAGEMENT...................................................................................... 25
11.1
Data collection, monitoring, data processing and archiving procedures............... 25
11.2
Report and data publishing.................................................................................... 25
12.
STATISTICS......................................................................................................... 26
12.1
Statistical analysis – general information.............................................................. 26
12.2
Description of endpoints ....................................................................................... 26
12.3
Description of stages of data analysis ................................................................... 27
12.4
Statistical methods................................................................................................. 27
12.5
Determination of sample size................................................................................ 27
13.
REFERENCES...................................................................................................... 27
APPENDIX 1. CLASSIFICATION OF SEVERITY OF AIRFLOW LIMITATION 
IN COPD (BASED ON POST-BRONCHODILATOR FEV1) ............................ 29
APPENDIX 2. FEDERAL CLINICAL GUIDELINES FOR DIAGNOSIS AND 
TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY 
DISEASE 2014 ..................................................................................................... 30
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LIST OF TABLES 
Table 1. Visit schedule ........................................................................................................ 17
 
LIST OF APPENDICES 
Appendix 1 – Classification of COPD severity (criteria) 
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APPENDIX 2. FEDERAL CLINICAL GUIDELINES FOR DIAGNOSIS 
AND TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY 
DISEASE 2014 LIST OF ABBREVIATIONS  
List of abbreviations  
Definition of the terms 
AE 
Adverse event  
ADR 
Adverse drug reaction 
CRF 
Case report form (paper) 
EC 
Ethics Committee  
GCP 
Good clinical practice 
ICH 
International Conference on Harmonization 
IEC 
Independent Ethics Committee 
NIS 
Non-interventional study 
PI 
Principal investigator 
Variables 
Parameters, patient examination results which can change in the course of 
time  
 

 
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1. 
INTRODUCTION 
1.1 
Background 
Definition of COPD 
COPD is a preventable and treatable disease characterized by persisting airflow limitation 
which typically progresses and associated with marked chronic inflammatory response in the 
lungs to pathogen particles or gases. In a number of patients, exacerbations and comorbidities 
can affect the general severity of COPD (GOLD 2015). 
COPD diagnosis should be suspected in all patients with dyspnoea, chronic cough or 
expectoration and/or history of risk factors characteristic of this disease. 
Experts of the World Health Organization (WHO) estimated that approximately 210 mln. 
people worldwide suffer from COPD. In our modern age, COPD represents one of the leading 
chronic diseases alongside with arterial hypertension, coronary heart disease and diabetes 
mellitus. They account for more than 30% among other human pathologies. COPD ranks 
fourth among causes of death worldwide, and is assumed to ascend to the third place by2020. 
According to estimations using epidemiological markers, in the Russian Federation there are 
approximately 11 mln. people suffering from COPD. Whereas according to official statistics 
their total number in the Russian Federation amounts to only 2.4 mln. This is due to 
underdiagnosis and patients seeking medical attention too late, which result in detection of the 
disease at advanced stages when even the most modern treatment methods cannot delay steady 
progression of the disease. [1] 
In the Russian Federation, diagnosis and treatment of COPD patients is performed primarily at 
community-based primary care outpatient polyclinic institutions. Every year in the Russian 
Federation there are approximately 100 thousands new cases of the disease diagnosed 
(statistics digest "Morbidity rates in adult population of Russia in 2012"). However, as a rule, 
COPD is diagnosed at advanced stages when complaints become a major problem for the 
patient. In many regions of the country, spirometric testing have still not been introduced into 
routine practice of primary care physicians, although on the positive side, in the recent years 
facilities of primary care outpatient polyclinic institutions have improved substantially. 
In the recent years, several studies with an objective to ascertain the real prevalence of COPD 
have been conducted in Russia. These studies demonstrated that COPD was observed 
approximately in 8% of the population over 18 years of age (Postnikova L.B., et al. 
Pulmonology, 2011) [3], and among those over 18 years of age the prevalence of this disease 
touches on 14.5% [4], (Zhestkov A.V., et al. Pulmonology, 2009).  

 
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In 2012 there were 2.7 mln. of COPD patients under surveillance at outpatient polyclinic 
institutions in the Russian Federation. However, we do not have at our disposal updated 
information regarding the prevalence of the disease in specific cities, distribution of these 
COPD patients by extent of airway obstruction. Data on pharmacotherapy are only 
approximate. 
In developed countries, total economy expenses associated with COPD take 2nd place in the 
structure of pulmonary diseases after lung cancer, and if we consider direct expenses COPD 
takes the 1st place exceeding direct expenses for bronchial asthma 1.9-fold. Economy 
expenses per patient associated with COPD 3 times exceed those for an asthma patient. Scarce 
reports of direct medical expenses in COPD show that more than 80% of resources are spent 
on inpatient care and less than 20% – on outpatient care. It has been established that 73% of 
costs are associated with 10% of patients with severe disease. The highest economic losses are 
brought about by treatment of COPD exacerbations. In Russia, the economic burden of COPD 
taking into account indirect expenses, including absenteeism (absence from work) and 
presenteeism (less effective work caused by illness), amounts to 24.1 bln. roubles. [2]  
1.2 
Study rationale 
The majority of COPD patients in the Russian Federation seek medical attention from primary 
care physicians at outpatient polyclinic institutions. Physicians of these institutions can refer a 
patient for spirometric testing or to a pulmonologist (in this case, as a general rule, spirometry 
is also performed). 
In the recent years in Europe registries of COPD patients have been created: Registry of 
COPD phenotypes in patients in Central and Eastern Europe (POPE Study- Phenotypes of 
COPD in Central and Eastern Europe) 2014-2015, Czech multicentre registry of COPD 
patients, started in 2014 (Czech Multicentre Research Database of COPD, Novotná et al. 
Czech multicenter research database of severe COPD. International Journal of Chronic 
Obstructive Pulmonary Disease 2014, 9: 1265-1274".) 
Registry of COPD patients includes monitoring of the possible causes of the disease, 
prevalence of different phenotypes, assessment of disease progression, therapeutic approaches 
to disease treatment in real-life clinical practice, analysis of social and economical disease 
burden. 
It is an important clinical and economical goal to arrange a registry of COPD patients who 
undergo outpatient surveillance at polyclinic institutions of Moscow, including description of 
patient clinical profile, diagnosis flow chart, therapeutic treatment tactics using different 
groups of medicinal products, compliance of used diagnostic and therapeutic approaches with 
current Federal clinical guidelines for COPD diagnosis and treatment, evolution of COPD 
prevalence parameters, monitoring of course of the disease.  
In the absence of this information it is impossible to evaluate the quality of medical care 
provided to COPD patients in the Russian Federation or to plan any actions for treatment 
refinement. 

 
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Therefore, the purposes of the present study result from the necessity to perform the 
following: 
a) evaluate therapeutic trends in an outpatient polyclinic setting for patients with diagnosed 
COPD, 
b) define clinical profile of COPD patients seeking attention and/or present in outpatient 
polyclinic medical care of healthcare system of Moscow (including diagnosis and therapeutic 
treatment tactics using different therapy regimens). 
c) determine the extent of the therapy conducted and its compliance with diagnosis, disease 
severity and phenotype 
d) define the disease burden (number of outpatient visits, hospitalizations, disability) 
Investigation of the management of COPD patients in real-life clinical practice will enable us 
to obtain demographic and social data of the patients, study the natural history of COPD,  
evaluate 
the 
efficacy 
of 
therapy, 
demand 
for 
specialized 
treatment, 
perform 
pharmacoeconomic analysis, and develop standard statistical forms. 
2. 
STUDY OBJECTIVES 
2.1. 
Primary study objective 
1. To describe the clinical profile of COPD patient who is under outpatient surveillance at 
polyclinic institutions of Moscow (including demographic data (age, gender, ethnicity, 
occupation), smoking status, disease duration, disease severity grade, distribution by 
disease phenotype, disease exacerbation rate in the setting of real-life clinical practice) 
2.2. 
Secondary objectives 
1. Characterize distribution (percentage (%)) of COPD patients who seek attention from 
primary medical care physicians by severity of airway obstruction, by reversibility of 
airway obstruction according to criteria described in Federal clinical guidelines for COPD 
diagnosis and treatment 2014 
2. To determine prevalence of the different disease phenotypes among outpatients: chronic 
bronchitis phenotype, emphysema phenotype, mixed phenotype, frequent exacerbator 
phenotype, Asthma+COPD phenotype (according to criteria described in Federal clinical 
guidelines for COPD diagnosis and treatment 2013) 
3. To determine the percentage of patients with eosinophilic inflammation according to 
haematology results 
4. To describe treatment regimens prescribed to COPD patients depending on disease 
severity grade in the setting of real-life clinical practice 

 
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5. To establish the percentage of medical prescriptions for treatment of COPD patients 
which comply with current Federal clinical guidelines for diagnosis and treatment of 
chronic obstructive pulmonary disease 
6. To establish prevalence and pattern of comorbidities in COPD patients 
7. To evaluate the disease burden based on the collected data concerning the duration of 
temporary disability, number of hospitalizations due to COPD exacerbations, number of 
outpatient visits concerning COPD patients under outpatient surveillance at polyclinic 
institutions of Moscow for three years 
3. 
STUDY PLAN AND PROCEDURES 
The registry of COPD patients represents a non-interventional multicenter descriptive 
retrospective study of all COPD patients, which medical records will be retrospectively added 
to the registry database and newly diagnosed under outpatient surveillance at the selected 
polyclinic institutions of Moscow with retrospective entry of data. 
it will include all patients with registered diagnoses J40 - J44 according to ICD-10 with 
spirometry results confirming COPD diagnosis, who are at the study start under outpatient 
surveillance, and also newly registered patients diagnosed with COPD ( ICD-10 J40 - J44, as 
confirmed by spirometry results) during the conduction of the registry program at the selected 
polyclinic institutions of Moscow (according to ICD: J40 - Bronchitis, not specified as acute 
or chronic, J41 - Simple and mucopurulent chronic bronchitis, J41.0 - Simple chronic 
bronchitis, J41.8 - Mixed simple and mucopurulent chronic bronchitis, J 42 - Unspecified 
chronic bronchitis, J 43 - Emphysema, J 44 - Other chronic obstructive pulmonary disease) 
based on regular (yearly) retrospective analysis of patient records with data entry into a 
consolidated database. 
It is planned to enrol into the study approximately 2000 male and female patients over 40 
years of age with diagnosed COPD (as confirmed by spirometry results). 
The present observational multicenter descriptive study will be conducted in the setting of 
routine clinical practice of outpatient polyclinic institutions. There is no hypothesis to be 
tested in this study.  
The study will be conducted in outpatient polyclinic institutions of the primary medical care 
system of Moscow. Pulmonologists of the primary medical care system will be engaged as 
investigators. These are the physicians, whom the patients with tentative COPD diagnosis are 
referred to in the Russian Federation and who within the scope of their responsibilities have 
access to source medical records and who evaluate the quality of diagnosis and extent of 
treatment prescribed to COPD patients.  
The present study is observational therefore it does not require a treatment regimen or 
directions for patient management. The patients receive medical care in line with routine 
practice for treatment of this disease in the Russian Federation. Patient participation in the 

 
Number/Code:  
Version: 
Date: 
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study should not in any way affect the principles and extent of treatment received by the 
patient according to routine clinical practice. 
Physicians-investigators will enter into the study the information (data) concerning COPD 
patients, both those already registered at the selected medical treatment and preventive care 
institution, and newly registered patients as they seek attention at the outpatient polyclinic 
institutions during the registry conduction period. 
The main purpose of the present study consists in collection of data concerning COPD 
patients under surveillance at outpatient polyclinic institutions of Moscow using patient 
medical records and their medical history. This protocol does not specify any obligatory visits 
or examinations. 
Patient data will be entered into the registry de-identified. The patients will be identified by 
their screening number and initials. Then the Physician-investigator will evaluate patient 
compliance with inclusion criteria. The study will enrol patients meeting all the inclusion 
criteria and not having any of the exclusion criteria.  
Only the physician who enters patient data into the regional COPD registry possesses patient 
contact information, and henceforth only this physician will enter de-identified patient data 
according to study design. This physician does not influence the choice of examination extent, 
treatment strategy and medication.  
Visit "Enrolment". At this visit de-identified data of the patients will be included into the 
study. De-identified data are entered retrospectively based on analysis of the outpatient 
medical records. 
At this visit the Physician-investigator will complete the following information (collected 
retrospectively): 
1. Verify inclusion/ exclusion criteria 
2. Establish the date of COPD diagnosis  
3. Collect 
medical 
history 
concerning 
significant 
comorbidities 
and 
clinical 
characteristics, rate of exacerbations, pneumonia cases, hospitalizations, number of 
outpatient visits concerning COPD, number of days of disability in the year prior to 
enrolment 
4. Evaluate smoking status. Wherever possible, smoking in pack-years 
5. Collect medical history concerning treatment regimens, including different regimens of 
CS use, which the patient took/was prescribed in the year prior to enrolment into the 
registry (trade name of the medicinal product and INN, doses, dosing regimen, 
duration of use) 
6. Collect demographic data and information concerning the patient's socioeconomic 
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7. Collect data concerning the results of laboratory tests and instrumental examination 
methods confirming COPD diagnosis, present in the outpatient medical records 
(spirometry, specific complaints, haematology, instrumental examination methods) 
8. Determine the patient's phenotype according to current classification 
9. Collect data concerning adverse drug reactions 
10. Complete the CRF. 
Table 1. 
Visit schedule 
Procedures 
Visit 
"Enrolment" 
Timelines  
At the moment of enrolment 
into the registry 
Inclusion / exclusion criteria 
Х 
COPD. Severity grade, reversibility of airway obstruction (according to 
spirometry results*) 
Х 
Demographics (year of birth, ethnicity, gender), 
X 
Socioeconomic status (education, occupation) 
X 
Smoking status 
Х 
Occupational status, including information regarding the number of days of 
disability in the past 1 year. 
X 
Height, Weight, BMI (if applicable) 
X 
Comorbidities and clinical characteristics  
Х 
Number of exacerbations COPD 
Х 
Number of outpatient visits concerning COPD per year  
Х 
Mean number of hospitalizations due to COPD 
Х 
Determination of patient's phenotype according to current classification  
X 
Medical history concerning prior treatment of COPD 
Х 
Medical history concerning treatment of COPD in the year prior to enrolment  
Х 
Collection of data regarding changes if regimens of COPD treatment in the year 
prior to enrolment 
Х 
Information concerning new complaints 
 
Spirometry. Results evolution (if applicable*) 
Х 
Chest X-ray examination (if applicable*) 
X* 
Eosinophilia (eosinophil blood count based on haematology (Data of Le, EOS in 
% and incells per µl (haematology) 
Х 
Pulse oximetry (if applicable*) 
X* 
Adverse drug reactions 
Х 
CRF completion 
 
4. 
PATIENT POPULATION 
4.1 
Physicians-investigators 
The present study is non-interventional (an observational, multicenter, descriptive study). 
Randomly selected polyclinic institutions of Moscow will take part in the study and enrol into 
the registry 2000 COPD patients. 

 
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The patient population includes male and female patients over 40 years of age, smokers or ex-
smokers, under outpatient surveillance at polyclinic institutions of Moscow with diagnosis 
codes according to ICD J40 - J44 and diagnosed COPD, as confirmed by spirometry results.  
4.2 
Selection criteria for COPD patients 
4.2.1 
Inclusion criteria for patients with diagnosed COPD 
1. Male and female patients ≥ 40 years, smokers or ex-smokers, with previously 
diagnosed COPD 
2. COPD diagnosis corresponding to ICD codes J40 - J44 (J40 - Bronchitis, not specified 
as acute or chronic, J41 - Simple and mucopurulent chronic bronchitis, J41.0 - Simple 
chronic bronchitis, J41.8 - Mixed simple and mucopurulent chronic bronchitis, J 42 - 
Unspecified chronic bronchitis, J 43 - Emphysema, J 44 - Other chronic obstructive 
pulmonary disease 
3. COPD diagnosis confirmed by spirometry results (spirometry is performed as normal 
with bronchodilator testing using salbutamol 400 µg, post-BD FEV1\ FVC < 0.7) 
Spirometric diagnosis of disease severity should be made in line with COPD 
assessment according to GOLD criteria.  
4.2.2 
Exclusion criteria for patients with COPD risk factors and for patients with 
previously diagnosed COPD 
A patient with diagnosed COPD should not meet any of the exclusion criteria. If a patient with 
previously diagnosed COPD meets at least one of the exclusion criteria such patient cannot be 
enrolled into the study. 
1. Pulmonary comorbidities, such as tuberculosis, sarcoidosis 
5. 
PATIENT WITHDRAWAL FROM THE STUDY 
5.1 
Withdrawal criteria 
A patient can be withdrawn from the study due to the following reasons: 
1. A patient can be withdrawn from the study if he/she was enrolled in breach of 
inclusion/exclusion criteria. 
5.2 
Procedures for patient withdrawal from the study 
In case if a patient is withdrawn from the study, he/she will continue receiving the necessary 
treatment in line with routine practice.  

 
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6. 
PATIENT TREATMENT 
6.1 
Treatment strategy in observational studies 
This study is observational therefore it does not require a specific treatment regimen or 
instructions for patient management. The question of patient "assignment" to a specific 
treatment strategy is not predetermined by the study protocol. The patients receive medical 
care in line with routine practice for treatment of this disease in the Russian Federation. 
Patient participation in the study should not in any way affect the principles and extent of 
treatment received by him/her according to routine clinical practice. 
7. 
STUDY CONDUCTION 
7.1 
Description of the visits 
Visit "Enrolment". At this visit the patients will be enrolled into the study. De-identified 
data are entered retrospectively based on analysis of the outpatient medical records. 
At this visit the Physician-investigator will complete the following information (collected 
retrospectively): 
1. Verify inclusion/exclusion criteria 
2. Establish the date of COPD diagnosis 
3. Collect 
medical 
history 
concerning 
significant 
comorbidities 
and 
clinical 
characteristics, rate of exacerbations, pneumonia cases, hospitalizations, number of 
emergency calls, number of outpatient visits concerning COPD, number of days of 
disability in the year prior to enrolment 
4. Evaluate smoking status. Wherever possible, smoking in pack-years 
5. Collect medical history concerning treatment regimens, including different regimens 
of CS use, which the patient took/was prescribed in the year prior to enrolment into the 
registry (trade name of the medicinal product and INN, doses, dosing regimen, 
duration of use) 
6. Collect demographic data and information concerning the patient's socioeconomic 
status 
7. Collect data concerning the results of laboratory tests and instrumental examination 
methods confirming COPD diagnosis, present in the outpatient medical records 
(spirometry, specific complaints, haematology, instrumental examination methods) 
8. Determine the patient's phenotype according to current classification 
9. Collect data concerning adverse drug reactions 
10. Complete the CRF. 

 
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8. 
PARAMETERS COLLECTED FOR STUDY, ASSESSMENT 
AND REGISTRATION METHODS 
Spirometric classification of airflow limitation in COPD (refer to Appendix 2) 
Spirometric classification of airflow limitation is divided into 4 stages (GOLD 1 –mild; 
GOLD 2 – moderate; GOLD 3 – severe; GOLD 4 – very severe), as seen in patients with 
FEV1/FVC < 0.70, based on post-bronchodilator FEV1 (reference to GOLD). 
 
Assessment of exacerbations 
A COPD exacerbation is defined as an acute event characterized by deterioration of 
respiratory symptoms outside the range of their day-to-day variations and requiring change of 
treatment. The rate of exacerbations substantially varies in different patients. 
In the group people suffering from COPD, the number of disease exacerbations in the last year 
is of outstanding interest to us. A COPD exacerbation represents any deterioration in the 
patient's health which manifests as intensification of symptoms: worsened dyspnoea, cough, 
more sputum or altered sputum characteristics –purulent sputum. During exacerbations, either 
all of these symptoms or only some may intensify. Very often (approximately in 50% of 
cases) an exacerbation is associated with a viral or bacterial infection and accompanied with 
fever and/or respiratory infection symptoms. 
8.1 
Primary endpoint 
1. Description of the clinical profile of COPD patient under outpatient treatment/ 
surveillance at outpatient polyclinic healthcare institutions of the Russian Federation in 
Moscow. 
8.2 
Secondary endpoints 
1. Percentage (%) of patients with different disease phenotypes among outpatients 
2. Percentage (%)of prescriptions of medicinal products to COPD patients which are in 
line with their disease severity according to Federal clinical guidelines for diagnosis 
and treatment of COPD patients, 2014 
3. Distribution (%) of COPD patients who seek attention from primary medical care 
physicians by severity of airway obstruction (according to Federal clinical guidelines 
for diagnosis and treatment of COPD patients, 2014) 
4. Mean number of exacerbations requiring medical attention (outpatient prescription of 
oral corticosteroids CS and/or antibiotics) in the last year in COPD patients 
5. Mean number of hospitalizations in the last year in COPD patients 
6. Mean duration (seriousness) of a temporary disability case. Number of days of 
temporary disability /Number of cases of temporary disability (reference form 16-ВН)  
7. Percentage (%) of COPD patients who received different regimens for treatment of 
COPD, including short-acting muscarinic antagonist (SAMA), short-acting β2-agonists 
(SABA), long-acting β2-agonists (LABA), long-acting muscarinic antagonist (LAMA), 

 
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oral corticosteroids (oral CS), fixed dose combination (FDC), phosphodeisterase-4 
inhibitor, theophylline for the past year 
8. Percentage (%) prescriptions to COPD patients which are in line with their disease 
severity according to GOLD classification and Federal clinical guidelines for treatment 
choice 
9. Percentage (%) of patients with eosinophilic inflammation (eosinophil count according 
to haematology >2%,> 3%, >4% or equivalent to absolute counts of >200, > 300, >400 
cells per µl) 
10. Percentage of patients receiving sufficient extent of treatment in line with disease 
severity according to Federal clinical guidelines for diagnosis and treatment of COPD 
patients, 2014 
11. Disease burden based on the collected data concerning the duration of temporary 
disability, number of hospitalizations due to COPD exacerbations, outpatient visits 
concerning COPD during follow-up  
8.3 
Economic health assessment  
An assessment of the duration of health-related temporary disability will be made based on the 
collected data (number of hospitalizations due to COPD exacerbations, outpatient visits 
concerning COPD) in the observational study. 
8.3.1 
Disease burden assessment 
An assessment of the duration of health-related temporary disability will be made based on the 
collected data (number of hospitalizations due to COPD exacerbations, outpatient visits 
concerning COPD) in the observational study. 
8.3.2 
Other parameters for disease burden assessment 
No other parameters will be evaluated as part of this Protocol. 
9. 
SAFETY ASSESSMENT 
9.1 Definitions 
9.1.1 Definition of an adverse event (AE) 
Adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical 
study/trial subject administered a pharmaceutical/investigational medicinal product and which 
does not necessarily have a causal relationship with this treatment.  
Adverse event can be any unfavourable symptom (e.g. nausea, chest pain) and unintended 
sign (e.g. tachycardia, enlarged liver) or an abnormal result of investigation (e.g. abnormal 
laboratory finding, electrocardiogram)  

 
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The AE definition is used both for serious and non-serious adverse events to regulatory 
authorities of the Russian Federation. 
Furthermore the following events are subject to registration and Investigator is responsible for 
reporting the medicinal product safety related information to the regulatory authorities of the 
Russian Federation including but not limited: reports regarding administration of the 
medicinal product during pregnancy and/or lactation, drug interactions, lack of therapeutic 
effect, overdose, abuse, misuse, off-label use, suicide attempt or suicide death 
 
9.1.2 Definition of a serious adverse event (SAE) 
Any untoward medical occurrence that at any dose of the medicinal product: 
- 
results in death; 
- 
is life-threatening; 
- 
requires inpatient hospitalization or prolongation of existing hospitalization; 
- 
results in persistent or significant disability/incapacity; 
- 
is a congenital anomaly/birth defect; 
- 
is any other clinically significant medical occurrence which may threaten the 
patient or require medical attention. 
 
NOTE. 
• The term "life-threatening" refers to any event during which there is a risk of death for 
the patient; it does not refer to an event which hypothetically could have led to a lethal 
outcome if it were more severe. 
Medical occurrences of special interest, but not resulting in death or life-threatening events or 
requiring hospitalization, can also be considered serious adverse events in those cases when 
according to medical and scientific judgement they might jeopardise the patient (or patients) 
and might require therapeutic or surgical intervention to prevent one of the other outcomes 
listed above. Any suspected transmission via a medicinal product of an infectious agent is also 
considered an SAE. Any organism, virus or infectious particle (for example Prion Protein 
Transmitting Transmissible Spongiform Encephalopathy), pathogenic or non-pathogenic, is 
considered an infectious agent. In such case these events are regarded as serious. Examples of 
such events are advanced or malignant tumour, intensive treatment in an emergency room or 
at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in 
hospitalization, or development of dependency, or drug abuse. 
 
9.2 Non-interventional studies without specific safety assessment objectives 
As the present study is non-interventional, there will be no proactive collection of any safety 
data. All the reports concerning events associated with safety of medicinal products will be 
reported in line with pharmacovigilance regulatory requirements in the post-marketing period 
as spontaneous adverse event reports. It is crucial that all the employees participating in the 
study are aware of the contents of this section. The Principal Investigator or a designated 

 
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authorized representative is responsible for AE reporting to regulatory authorities in according 
local regulations and timelines, ensure that all the site employees participating in the study 
aware about the procedures for handling of spontaneous reports (the term spontaneous reports 
implies reports associated with safety of medicinal products), and also national 
pharmacovigilance regulatory requirements in Russia. 
9.3 Non-interventional studies with specific safety assessment objectives 
As the present study is non-interventional, there will be no proactive collection of any safety 
data. 
9.4 Safety data reporting 
9.4.1 Adverse event reports 
Monitoring of the safety relation information of the investigation medicinal products should 
be performed according to the local pharmacovigilance requirements to standard medical 
practice in the territory of the Russian legislation. 
9.4.2 Reports of unexpected adverse events during use of medicinal products for 
human use 
As the present study does not stipulate any investigational medicinal product or vaccine, and 
includes only observation of patients receiving standard treatment with medicinal products 
approved for use in the territory of the Russian Federation, safety monitoring and reports 
regarding adverse events (including unexpected events) will be performed according to local 
pharmacovigilance requirements to standard medical practice in the territory of the Russian 
Federation.  
9.4.3 Registration of spontaneous reports regarding adverse events  
The following principles should be applied in case of registration of adverse events in study 
participants: the investigator should report adverse events per pharmacovigilance procedures 
according to local regulatory requirements: 
 
1. To the Federal Service for Surveillance in Healthcare: In writing to the following address: 
Russian Federation, 109074, Moscow, Slavianskaya sq., 4, b. 1. A specific form should 
be used currently available at: 
http://www.roszdravnadzor.ru/i/upload/files/1308641445.19876-26263.doc  
 
2. To the corresponding pharmaceutical company, i.e. the marketing authorization holder of 
the appropriate medicinal product, according to local regulatory requirements. 

 
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10. 
ETHICS 
This non-interventional multicenter study will be conducted in compliance with the Protocol, 
the Declaration of Helsinki, ICH GCP guideline, GEP and all the current local legislative 
requirements to conduction of non-interventional studies. 
Physicians will conduct this non-interventional multicenter study in line with all current 
regulatory and legislative requirements to routine medical practice in the Russian Federation. 
10.1 
Committee on ethical review for clinical studies (EC) 
Before study start, written favourable conclusion of EC (ethics committee) should be received 
concerning the study protocol, ICF and CRF. If in the course of the study any amendments to 
these documents are made, written approval should be received before their implementation. 
10.2 
Informed consent 
The present study is retrospective and thus based on data which will be retrieved from 
archives kept by the investigators. Therefore, in this non-interventional study the choice of a 
specific therapeutic strategy for each patient has already been made and there is no need for 
prospective conduction of any additional diagnostic or monitoring procedures. Collection of 
patient data will be performed only by the personnel of the clinical institution; as these data 
will not include any information enabling identification of the patient, in the present study 
there is no need to obtain patient informed consent (according to the personal data protection 
law of the Russian Federation). 
10.3 
Patient data confidentiality 
 The present study is retrospective and is thus based on data which will be retrieved from 
archives kept by the investigators. Collection of patient data will be performed by the 
personnel of the clinical institution; as these data will not include any information enabling 
identification of the patient, in the present study there is no need to obtain patient informed 
consent (according to the personal data protection law of the Russian Federation).  
Identification number assigned by the investigator to each patient will be used instead of the 
patient's name in order to protect patient's personal data during reporting of adverse events 
and/or other study-related data. Identification number will consist of four digits, the first two 
will stay the same for all the patients from the same investigational site (site code), and the 
last two digits will be individual for this patient, whose medical records will be analysed at the 
site (patient code). 
10.4 
Training for physicians 
Physicians should be trained on study conduction. New information regarding the study 
conduction should be provided to the physicians in a timely manner.  
Physicians should be trained on local regulatory requirements to pharmacovigilance 
procedures. If they become aware of an adverse event occurring in the setting of 

 
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administration of either an investigational medicinal product or a vaccine, they should register 
and report the information to the contacts provided above within the timelines set by the 
requirements of local pharmacovigilance. 
10.5 
Study timeframes and completion timelines 
Study conduction plan: 
• 
Date of enrolment of first patient: 4 quarter 2016 
• 
Date of enrolment of last patient: 2 quarter 2018 
• 
Date of database lock: 4 quarter 2018 
11. 
DATA MANAGEMENT 
11.1 
Data collection, monitoring, data processing and archiving 
procedures 
The physician participating in the study collects data according to this study and any rules set 
by his/her institution. 
By signing this protocol, the physician consents to conduct the present non-interventional 
study with all due efforts in line with the protocol, general provisions of Good clinical practice 
and all local legislation and regulations applicable to conduction of non-interventional studies.  
The physician also provides his/her consent for monitoring, auditing, inspections by the Ethics 
Committee and inspections of documentation and study procedures by the regulatory 
authorities and undertakes to provide direct access to all study data and documentation. 
The physician undertakes to prepare and maintain accurate study documentation in line with 
principles of Good clinical practice and local legislation, regulations and restrictions, and to 
provide comprehensive data concerning each patient in de-identified format.  
The investigator is obliged to maintain copies of all study-specific documentation and records 
in line with all legislative and regulatory requirements. Such documentations includes without 
limitation the protocol, CRF/source documentation, adverse event reports, communication 
with regulatory authorities and institutional review board/ Independent Ethics Committee, 
documentation regarding all monitoring visits, normal ranges. All study documentation should 
be readily available upon request from the regulatory authorities.  
The physician is responsible for accuracy and correctness of patient data records. 
11.2 
Report and data publishing 
• 
Preparation of a study report within 12 months of its completion. 
• 
The report should be signed by the Principal investigator 
• 
Physicians will receive the study report  

 
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According to the Declaration of Helsinki, both authors, and editors, and publishers are 
ethically responsible for the publication of study results. The authors are obliged to maintain 
the accuracy of results. Both favourable and negative findings should be published or 
otherwise made publicly available.  
The publication of individual pieces of data collected in individual institutions participating in 
multicenter studies should not precede publication of the primary manuscript. When 
individual data are prepared for publication, the first publication of the study data should 
always be referenced. 
12. 
STATISTICS  
12.1 
Statistical analysis – general information 
Non-interventional study is a study which applies epidemiological methods, including other 
methods used for analysis of data concerning human health. 
12.2 
Description of endpoints 
Primary endpoints 
1. Description of the clinical profile of COPD patient under outpatient treatment/ 
surveillance at outpatient polyclinic healthcare institutions of the Russian Federation in 
Moscow 
Secondary endpoints 
1. Percentage (%) of patients with different disease phenotypes among outpatients 
2. Percentage (%)of prescriptions of medicinal products to COPD patients which are in 
line with their disease severity according to Federal clinical guidelines for diagnosis 
and treatment of COPD patients, 2014 
3. Distribution (%) of COPD patients who seek attention from primary medical care 
physicians by severity of airway obstruction (according to Federal clinical guidelines 
for diagnosis and treatment of COPD patients, 2014) 
4. Mean number of exacerbations requiring medical attention (outpatient prescription of 
oral corticosteroids CS and/or antibiotics) in the last year in COPD patients 
5. Mean number of hospitalizations in the last year in COPD patients 
6. Mean duration (seriousness) of a temporary disability case. Number of days of 
temporary disability /Number of cases of temporary disability (reference form 16-ВН) 
7. Percentage (%) of COPD patients who received different regimens for treatment of 
COPD, including short-acting muscarinic antagonist (SAMA), short-acting β2-agonists 

 
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(SABA), long-acting β2-agonists (LABA), long-acting muscarinic antagonist (LAMA), 
oral corticosteroids (oral CS), fixed dose combination (FDC), phosphodeisterase-4 
inhibitor, theophylline for the past year 
8. Percentage (%) prescriptions to COPD patients which are in line with their disease 
severity according to GOLD classification and Federal clinical guidelines for treatment 
choice 
9. Percentage (%) of patients with eosinophilic inflammation (eosinophil count according 
to haematology >2%,> 3%, >4% or equivalent to absolute counts of >200, > 300, >400 
cells per µl) 
10. Percentage of patients receiving sufficient extent of treatment in line with disease 
severity according to Federal clinical guidelines 
11. Disease burden based on the collected data concerning the duration of temporary 
disability, number of hospitalizations due to COPD exacerbations, outpatient visits 
concerning COPD during follow-up 
12.3 
Description of stages of data analysis 
All data will be analysed after database lock. 
12.4 
Statistical methods 
Descriptive statistics methods will be used for data processing. 
12.5 
Determination of sample size 
Sample size in this study was not calculated. 
13. 
REFERENCES 
1. http://www.medlinks.ru/article.php?sid=61497 
2. Kolosov V.P., Trofimova A.Yu., Naryshkina S.V. Quality of life of patients with chronic 
obstructive lung disease. – Blagoveshchensk, 2011. – 132 p) 
3. Постникова Л.Б. с соавт. Пульмонология , 2011  
4. Zhestkov A.V., et al. Pulmonology, 2009 
5. Statistics digest " Morbidity rates in total population of Russia in 2012" 
6. Statistics digest " Morbidity rates in the population of Russia of working age in 2012 " 
7. Statistics digest " Morbidity rates in adult population of Russia in 2012" 
8. Fležar M et al. International Journal of COPD 2013:8 483–492 
9. Чучалин, А., Айсанов, З., & С.Н., А. (2014). Федеральные клинические 
рекомендации по диагностике и лечению. Москва: Российское респираторное 
общество. 

 
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10. Chow, S., Shao, J., & Wang, H. (2008). Sample Size Calculations in Clinical Research. 
CRC Biostatistics Series (2 ed.). Chapman & Hall. 
11. Chuchalin, A., Khaltaev, N., Antonov, N., Galkin, D., Manakov, L., Antonini, P., . . . 
Demko, I. (2014). Chronic respiratory diseases and risk factors in 12 regions of the russian 
Federation. International Journal of COPD, 9, 963-974. 
12. Julious, S. A. (2010). Sample Sizes for Clinical Trials. CRC Press/Taylor & Francis. 

 
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APPENDIX 1. CLASSIFICATION OF SEVERITY OF AIRFLOW 
LIMITATION IN COPD (BASED ON POST-BRONCHODILATOR FEV1) 
Classification of severity of airflow limitation 
in COPD (based on post-bronchodilator FEV1) 
 
In patients with FEV1/FVC <0.70: 
GOLD 1: 
Mild FEV1 ≥80% of predicted 
GOLD 2: 
Moderate 50% ≤ FEV1 < 80% of predicted 
GOLD 3: 
Severe 30% ≤ FEV1 < 50% of predicted 
GOLD 4: 
Very severe FEV1 <30% of predicted 
 

 
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APPENDIX 2. FEDERAL CLINICAL GUIDELINES FOR DIAGNOSIS 
AND TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY 
DISEASE 2014 
REFERENCE HTTP://PULMONOLOGY.RU/PUBLICATIONS/GUIDE.PHP