Phenotypes of COPD in Central and Eastern Europe

NCT ID: NCT02119494

Last Updated: 2016-04-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3504 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-12-31

Brief Summary

The purpose of this study is to assess the representation of COPD patients in terms of categories and phenotypes of the disease in selected countries in Central and Eastern Europe (CEE). The results of The POPE study will allow for evaluation of the differences in clinical approaches and treatment practices. The following countries are represented in The POPE study: Czech Republic, Slovakia, Austria, Poland, Hungary, Russia, Croatia, Serbia, Slovenia, Estonia, Latvia and Bulgaria.

Detailed Description

Chronic Obstructive Pulmonary Disease (COPD) is a significant cause of morbidity and mortality in Europe and a major consumer of resources in both primary and secondary healthcare (1,2). Both clinical features of disease severity and quality of COPD patient care may have substantial influence on disease outcomes. Traditionally, COPD has been categorized using the FEV1 (forced expiratory volume at one second ) - based GOLD (The Global Initiative for Chronic Obstructive Lung Disease) classification . Other factors independently associated with survival include age, dyspnoea, health status, hyperinflation, gas exchange abnormalities, exacerbation frequency, exercise capacity, pulmonary hemodynamic, and nutritional status (3). Together these factors explain some of the existent heterogeneity within each GOLD stage in terms of symptoms, exacerbations, quality of life and exercise capacity (4).

Recently, interest has emerged for the identification of clinical COPD phenotypes, as defined by ''a single or combination of disease attributes that describe difference between individuals with COPD as they relate to clinically meaningful outcomes'' (5). Many previous studies have attempted to identify and quantify the prevalence of different phenotypes of COPD using populations of various sources, severities, and particularities. Yet there is no consensus on the number and definition of different phenotypes. However, there must be a compromise between the oversimplification of the term COPD as a definition that encompasses the entire spectrum of patients with incompletely reversible airflow obstruction caused largely by smoking and the complexity of considering each patient individually as an orphan disease.

The most frequently reported phenotypes are emphysema and chronic bronchitis, along with a subset of asthma sufferers. Recently, an extended list of proposed phenotypes have been proposed (6) including: (A) infrequent exacerbators with either chronic bronchitis or emphysema; (B) overlap COPD-asthma; (C) frequent exacerbators with emphysema predominant; and (D) frequent exacerbators with chronic bronchitis predominant. While there is consensus of substantial, but not complete, overlap among these phenotypes, the distribution of these phenotypes may differ widely between different countries and healthcare systems.

Thus, the objectives of this study are to better understand the patient characteristics and treatment patterns of those diagnosed with COPD between different CEE countries. Knowledge of this information may provide insight into the variability of phenotypes between different healthcare systems and may subsequently contribute to a better understanding of the factors associated with patient outcomes and have the potential to improve the care of COPD patients.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

1. Age > 40 years

2. Clinical diagnosis of COPD with post-bronchodilator FEV1/FVC < 0.7

3. Smoking burden ≥ 10 pack-years in smokers (group A). Evidence of exposure to at least one other typical inhaled COPD risk factor: environmental tobacco smoke, professional exposures, etc. (group B) Each country will include 300 COPD subjects with positive history of smoking (at least 10 pack-years). Consecutive non-smokers with COPD can be enrolled above this limit. Institute for Biostatistics and Analyses, Masaryk University, Brno, The Czech Republic will analyze both COPD groups (A and B) separately

4. Stable disease for at least 4 weeks

5. Outpatient status

6. Informed Consent

Exclusion Criteria

1. Exacerbation of COPD and/or instable co-morbid condition

2. Patient during hospital stay for whatever reason (lung or co-morbidities)

3. Patient is not able and willing to participate

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: collaborator

Zuzana Zbožínková, M.Sc.

OTHER

Sponsor Role: lead

Responsible Party

Zuzana Zbožínková, M.Sc.

project manager

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Arschang Valipour, Assoc. Prof., MD, PhD

Role: STUDY_DIRECTOR

Vienna Hospital Association

Vladimir Koblizek, MD, Ph.D

Role: STUDY_DIRECTOR

University Hospital Hradec Kralove

Ruzena Tkacova, Prof., MD, PhD

Role: STUDY_DIRECTOR

Pavol Jozef Šafárik University in Košice

Neven Tudoric, Prof., MD, Ph.D

Role: STUDY_DIRECTOR

University of Zagreb, Clinical Hospital Dubrava

Kyrill Zykov, MD, PhD

Role: STUDY_DIRECTOR

Moscow State University of Medicine and Dentistry

Attila Somfay, Prof., MD, PhD

Role: STUDY_DIRECTOR

University of Szeged, Faculty of Medicine, Dept. of Pulmonology

Adam Barczyk, MD, PhD

Role: STUDY_DIRECTOR

Katedra i Klinika Pneumonologii, Śląski Uniwersytet Medyczny

Marc Miravitlles, Prof., MD, PhD

Role: STUDY_DIRECTOR

Hospital Universitari Vall d'hebron Barcelona, Spain

Locations

Department of Internal Medicine, University Innsbruck

Innsbruck, , Austria

AKH Linz, Department of Pulmonary Medicine

Linz, , Austria

SKA der PV Weyer/Enns

Mühlein, , Austria

Pulmonary Rehabilitation Centre, Therme Wien

Vienna, , Austria

Ludwig Boltzmann Institute

Vienna, , Austria

Clinic for pneumonology and phisiatry, UMHAT "Dr. Georgi Stranski"

Pleven, , Bulgaria

Department of Respiratory Diseases, Medical University

Plovdiv, , Bulgaria

Pulmonary Diseases Clinic, Military Medical Academy

Sofia, , Bulgaria

Clinic of Pulmonology, MHAT "st. Marina"

Varna, , Bulgaria

Clinical Hospital

Osijek, , Croatia

University Hospital Centre

Rijeka, , Croatia

University Hospital Centre

Split, , Croatia

University Hospital Centre

Zagreb, , Croatia

University Hospital Dubrava

Zagreb, , Croatia

Pulmonary Outpatient Clinic, University Hospital Hradec Králové

Hradec Králové, , Czechia

Plicní ambulance Karlovy Vary

Karlovy Vary, , Czechia

Plicní ambulance Ostrava Poruba

Ostrava, , Czechia

Plicní ambulance Teplice

Teplice, , Czechia

Baja St. Rókus Hospital Patient Lung Care Institute

Baja, , Hungary

IZO PULM Health Service Ltd.

Budapest, , Hungary

Újpest Non-Profit Health Care Services Ltd.

Budapest, , Hungary

Csongrád County Hospital for Chest Diseases

Deszk, , Hungary

Medical Institution of Dr. Laszlo Romics Pulmonary Care

Érd, , Hungary

Elizabeth House Care Ltd.

Gödöllő, , Hungary

St. Elizabeth Hospital Pulmonary Care Institute

Jászberény, , Hungary

Szabolcs-Szatmár-Bereg County Hospitals and University Teaching Hospital

Nyíregyháza, , Hungary

Federated Institutes of Health Institute of Pulmonary Care

Pécs, , Hungary

Szarvas Respiratory Ltd.

Szarvas, , Hungary

Health Centre Balvi

Balvi, , Latvia

Bauska Hospital

Bauska, , Latvia

Ambulatory Clinic Jelgava

Jelgava, , Latvia

Regional Hospital of Jekabpils

Jēkabpils, , Latvia

Ambulatory Clinic Dubulti

Jūrmala, , Latvia

Kuldīga Hospital

Kuldīga, , Latvia

Regional Hospital of Liepaja

Liepāja, , Latvia

Madona Hospital

Madona, , Latvia

Privat practice Viktorija Vevere

Rēzekne, , Latvia

Health Centre 4, Ltd

Riga, , Latvia

LU MPI Institute privat practice

Riga, , Latvia

Pauls Stradins Clinical University Hospital

Riga, , Latvia

Riga 1st Hospital

Riga, , Latvia

Riga East Clinical University Hospital, In-patient Department "Centre of Tuberculosis and Lung Diseases

Riga, , Latvia

UniClinic

Riga, , Latvia

Health Centre

Talsi, , Latvia

rivat practice Ilona Uzbeka

Valka, , Latvia

Privat practice Dace Harasimjuka

Valmiera, , Latvia

Sia "Bini"

Ventspils, , Latvia

Oddział Chorób Płuc i Niewydolności Oddychania, Kujawsko - Pomorskie; Centrum Pulmonologii w Bydgoszczy

Bydgoszcz, , Poland

Klinika Alergologii i Pneumonologii, Uniwersyteckie Centrum Kliniczne, Szpital Gdańskiego Uniwersytetu Medycznego,

Gdansk, , Poland

Oddział Chorób Płuc, Wojewódzkie Centrum Szpitalne Kotliny Jeleniogórskiej,

Jelenia Góra, , Poland

Katedra i Klinika Pneumonologii, Śląski Uniwersytet Medyczny

Katowice, , Poland

Szpital Uniwersytecki, Oddział Kliniczny Kliniki Pulmonologii

Krakow, , Poland

Katedra i Klinika Pulmonologii, Alergologii i Onkologii Pulmonologicznej, Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu

Poznan, , Poland

Katedra i Klinika Chorób Wewnętrznych, Pneumonologii i Alergologii, Samodzielny Publiczny Centralny Szpital Kliniczny Warszawski Uniwersytet Medyczny,

Warsaw, , Poland

State Budget Educational Institution of High Professional Education "Kazan State Medical University"

Kazan', , Russia

I.M.Sechenov First Moscow State Medical University, University Hospital #1, Outpatient Department

Moscow, , Russia

Moscow State City Clinical Hospital No. 24

Moscow, , Russia

Moscow State University of Medicine and Dentistry named after A.I.Evdokimov

Moscow, , Russia

Pulmonology Research Institute

Moscow, , Russia

Clinic of Pulmonology of Scientific and Clinical Center of Interstitial and Orphan Lung Diseases

Saint Petersburg, , Russia

GBOU VPO Samara State Medical University

Samara, , Russia

Ufa State City Clinical Hospital

Ufa, , Russia

Vladivostok Clinical Hospital No.1

Vladivostok, , Russia

Clinic for Pulmonary Diseases, Clinical Centre of Serbia

Belgrade, , Serbia

Municipal Institute for Lung Diseases and Tuberculosis

Belgrade, , Serbia

Clinic for Pulmonary Diseases, Clinical Centre Kragujevac

Kragujevac, , Serbia

Clinic for Pulmonary Diseases, Clinical Center of Nis

Niš, , Serbia

Institute for Pulmonary Diseases and TB, Clinical Centre Vojvodina

Novi Sad, , Serbia

FNsP F.D. Roosevelta

Banská Bystrica, , Slovakia

NsP Sv. Jakuba

Bardejov, , Slovakia

Klinika pneumológie a ftizeológie LF SZU a UNB,

Bratislava, , Slovakia

Zdravotné stredisko Fedinova

Bratislava, , Slovakia

Ambulancia pneumológie a ftizeológie, ZAPA JJ s.r.o.,

Levice, , Slovakia

Klinika tubekulózy a respiračných chorôb JLF UK a UNM

Martin, , Slovakia

Dionea, s.r.o.

Nové Zámky, , Slovakia

Pľúcna ambulancia

Poprad, , Slovakia

NsP

Považská Bystrica, , Slovakia

Zdravotné stredisko Rimava

Rimavská Sobota, , Slovakia

Alveola, d.o.o.

Maribor, , Slovenia

Zdravstveni dom Murska Sobota

Murska Sobota, , Slovenia

Bolnišnica Topolšica

Topolšica, , Slovenia

Countries

Austria; Bulgaria; Croatia; Czechia; Hungary; Latvia; Poland; Russia; Serbia; Slovakia; Slovenia

References

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Other Identifiers

205.529

Identifier Type: -

Identifier Source: org_study_id