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Chronic Obstructive Pulmonary DiseasePOPENCT02119494

Phenotypes of COPD in Central and Eastern Europe

An observational study of Chronic Obstructive Pulmonary Disease, run by Zuzana Zbožínková, M.Sc. at 81 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Chronic Obstructive Pulmonary Disease
How many people
3,504 participants
Where
81 sitesin 11 countries
Study dates
Jun 2014to Dec 2015
How long will I take part?
7 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with COPD who visit selected specialised pulmonology clinics in the given time period.

Who may be able to join

  • Age > 40 years
  • Clinical diagnosis of COPD with post-bronchodilator FEV1/FVC < 0.7
  • 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
  • Stable disease for at least 4 weeks
  • Outpatient status
  • Informed Consent

Who cannot join

  • Exacerbation of COPD and/or instable co-morbid condition
  • Patient during hospital stay for whatever reason (lung or co-morbidities)
  • Patient is not able and willing to participate

Trial locations and contacts

81 sites in 11 countries.

81 sites in 11 countries

Latvia19 sites

  • Health Centre Balvi

    Balvi

  • Bauska Hospital

    Bauska

  • Regional Hospital of Jekabpils

    Jēkabpils

  • Ambulatory Clinic Jelgava

    Jelgava

  • Ambulatory Clinic Dubulti

    Jūrmala

  • Kuldīga Hospital

    Kuldīga

  • Regional Hospital of Liepaja

    Liepāja

  • Madona Hospital

    Madona

  • Privat practice Viktorija Vevere

    Rēzekne

  • Health Centre 4, Ltd

    Riga

  • LU MPI Institute privat practice

    Riga

  • Pauls Stradins Clinical University Hospital

    Riga

  • Riga 1st Hospital

    Riga

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

    Riga

  • UniClinic

    Riga

  • Health Centre

    Talsi

  • rivat practice Ilona Uzbeka

    Valka

  • Privat practice Dace Harasimjuka

    Valmiera

  • Sia "Bini"

    Ventspils

Other trials in Latvia

Hungary10 sites

  • Baja St. Rókus Hospital Patient Lung Care Institute

    Baja

  • IZO PULM Health Service Ltd.

    Budapest

  • Újpest Non-Profit Health Care Services Ltd.

    Budapest

  • Csongrád County Hospital for Chest Diseases

    Deszk

  • Medical Institution of Dr. Laszlo Romics Pulmonary Care

    Érd

  • Elizabeth House Care Ltd.

    Gödöllő

  • St. Elizabeth Hospital Pulmonary Care Institute

    Jászberény

  • Szabolcs-Szatmár-Bereg County Hospitals and University Teaching Hospital

    Nyíregyháza

  • Federated Institutes of Health Institute of Pulmonary Care

    Pécs

  • Szarvas Respiratory Ltd.

    Szarvas

Other trials in Hungary

Slovakia10 sites

  • FNsP F.D. Roosevelta

    Banská Bystrica, 97517

  • NsP Sv. Jakuba

    Bardejov, 085 01

  • Klinika pneumológie a ftizeológie LF SZU a UNB,

    Bratislava, 821 01

  • Zdravotné stredisko Fedinova

    Bratislava, 85101

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

    Levice, 934 01

  • Klinika tubekulózy a respiračných chorôb JLF UK a UNM

    Martin, 036 59

  • Dionea, s.r.o.

    Nové Zámky, 94001

  • Pľúcna ambulancia

    Poprad, 05801

  • NsP

    Považská Bystrica, 017 26

  • Zdravotné stredisko Rimava

    Rimavská Sobota, 979 01

Other trials in Slovakia

Russia9 sites

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

    Kazan'

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

    Moscow

  • Moscow State City Clinical Hospital No. 24

    Moscow

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

    Moscow

  • Pulmonology Research Institute

    Moscow

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

    Saint Petersburg

  • GBOU VPO Samara State Medical University

    Samara

  • Ufa State City Clinical Hospital

    Ufa

  • Vladivostok Clinical Hospital No.1

    Vladivostok

Other trials in Russia

Poland7 sites

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

    Bydgoszcz, 85-326

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

    Gdansk, 80-211

  • Oddział Chorób Płuc, Wojewódzkie Centrum Szpitalne Kotliny Jeleniogórskiej,

    Jelenia Góra, 58-506

  • Katedra i Klinika Pneumonologii, Śląski Uniwersytet Medyczny

    Katowice, 40-752

  • Szpital Uniwersytecki, Oddział Kliniczny Kliniki Pulmonologii

    Krakow, 31-066

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

    Poznan, 60-569

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

    Warsaw, 02-097

Other trials in Poland

Austria5 sites

  • Department of Internal Medicine, University Innsbruck

    Innsbruck, A-6020

  • AKH Linz, Department of Pulmonary Medicine

    Linz, 1090

  • SKA der PV Weyer/Enns

    Mühlein

  • Pulmonary Rehabilitation Centre, Therme Wien

    Vienna, 1100

  • Ludwig Boltzmann Institute

    Vienna

Other trials in Austria

Croatia5 sites

  • Clinical Hospital

    Osijek

  • University Hospital Centre

    Rijeka

  • University Hospital Centre

    Split

  • University Hospital Centre

    Zagreb

  • University Hospital Dubrava

    Zagreb

Other trials in Croatia

Serbia5 sites

  • Clinic for Pulmonary Diseases, Clinical Centre of Serbia

    Belgrade

  • Municipal Institute for Lung Diseases and Tuberculosis

    Belgrade

  • Clinic for Pulmonary Diseases, Clinical Centre Kragujevac

    Kragujevac

  • Clinic for Pulmonary Diseases, Clinical Center of Nis

    Niš

  • Institute for Pulmonary Diseases and TB, Clinical Centre Vojvodina

    Novi Sad

Other trials in Serbia

Bulgaria4 sites

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

    Pleven

  • Department of Respiratory Diseases, Medical University

    Plovdiv

  • Pulmonary Diseases Clinic, Military Medical Academy

    Sofia

  • Clinic of Pulmonology, MHAT "st. Marina"

    Varna

Other trials in Bulgaria

Czechia4 sites

  • Pulmonary Outpatient Clinic, University Hospital Hradec Králové

    Hradec Králové, 500 05

  • Plicní ambulance Karlovy Vary

    Karlovy Vary, 36066

  • Plicní ambulance Ostrava Poruba

    Ostrava

  • Plicní ambulance Teplice

    Teplice

Other trials in Czechia

Slovenia3 sites

  • Alveola, d.o.o.

    Maribor, 3326

  • Zdravstveni dom Murska Sobota

    Murska Sobota, 9000

  • Bolnišnica Topolšica

    Topolšica, 3326

Other trials in Slovenia

About this study

Official title: POPE-Study: Phenotypes Of COPD in Central and Eastern Europe Study

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.

Read the 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.

Keywords
chronic obstructive pulmonary disease, phenotypes, categories, stage, GOLD, treatment
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The distribution of COPD patients according to GOLD 2011 grades

    The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2011 classifies patients according to airflow limitation into four grades: GOLD1, Mild; GOLD 2, Moderate; GOLD 3, Severe; GOLD 4, Very severe

    Measured: 7 months

  2. The distribution of COPD patients according to GOLD 2011 categories of risk (A. B, C, D)

    Measured: 7 months

Secondary outcomes (5)

  1. The prevalence of various COPD phenotypes

    The COPD phenotypes are: bronchitis, emphysema phenotype, frequent exacerbators, pulmonary cachexia, COPD and asthma overlap, and COPD and bronchiectasis overlap

    Measured: 7 months

  2. The prevalence various medication prescription

    Measured: 7 months

  3. The prevalence of long term oxygen therapy use

    Measured: 7 months

  4. The prevalence of surgical treatments in COPD patients

    Measured: 7 months

  5. The use of body plethysmography, bronchodilator test, carbon monoxide diffusing capacity testing, bronchial challenge test and FeNO test in ambulatory care

    Measured: 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
3,504 participants (actual)
Target duration
7 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02119494
Sponsor's protocol ID
205.529
Acronym
POPE
Status last verified
Apr 2016
First submitted
16 Apr 2014
Last updated
5 Apr 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Gershon AS, Wang C, Wilton AS, Raut R, To T. Trends in chronic obstructive pulmonary disease prevalence, incidence, and mortality in ontario, Canada, 1996 to 2007: a population-based study. Arch Intern Med. 2010 Mar 22;170(6):560-5. doi: 10.1001/archinternmed.2010.17.

    PubMed 20308643

  • Menn P, Heinrich J, Huber RM, Jorres RA, John J, Karrasch S, Peters A, Schulz H, Holle R; KORA Study Group. Direct medical costs of COPD--an excess cost approach based on two population-based studies. Respir Med. 2012 Apr;106(4):540-8. doi: 10.1016/j.rmed.2011.10.013. Epub 2011 Nov 18.

    PubMed 22100535

  • Dolan S, Varkey B. Prognostic factors in chronic obstructive pulmonary disease. Curr Opin Pulm Med. 2005 Mar;11(2):149-52. doi: 10.1097/01.mcp.0000153548.36054.8f.

    PubMed 15699788

  • Agusti A, Calverley PM, Celli B, Coxson HO, Edwards LD, Lomas DA, MacNee W, Miller BE, Rennard S, Silverman EK, Tal-Singer R, Wouters E, Yates JC, Vestbo J; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) investigators. Characterisation of COPD heterogeneity in the ECLIPSE cohort. Respir Res. 2010 Sep 10;11(1):122. doi: 10.1186/1465-9921-11-122.

    PubMed 20831787

  • Han MK, Agusti A, Calverley PM, Celli BR, Criner G, Curtis JL, Fabbri LM, Goldin JG, Jones PW, Macnee W, Make BJ, Rabe KF, Rennard SI, Sciurba FC, Silverman EK, Vestbo J, Washko GR, Wouters EF, Martinez FJ. Chronic obstructive pulmonary disease phenotypes: the future of COPD. Am J Respir Crit Care Med. 2010 Sep 1;182(5):598-604. doi: 10.1164/rccm.200912-1843CC. Epub 2010 Jun 3.

    PubMed 20522794

  • Miravitlles M, Soler-Cataluna JJ, Calle M, Molina J, Almagro P, Quintano JA, Trigueros JA, Pinera P, Simon A, Riesco JA, Ancochea J, Soriano JB. A new approach to grading and treating COPD based on clinical phenotypes: summary of the Spanish COPD guidelines (GesEPOC). Prim Care Respir J. 2013 Mar;22(1):117-21. doi: 10.4104/pcrj.2013.00016.

    PubMed 23443227

  • Miravitlles M, Koblizek V, Esquinas C, Milenkovic B, Barczyk A, Tkacova R, Somfay A, Zykov K, Tudoric N, Kostov K, Zbozinkova Z, Svoboda M, Sorli J, Krams A, Valipour A. Determinants of CAT (COPD Assessment Test) scores in a population of patients with COPD in central and Eastern Europe: The POPE study. Respir Med. 2019 Apr;150:141-148. doi: 10.1016/j.rmed.2019.03.007. Epub 2019 Mar 21.

    PubMed 30961941

  • Tudoric N, Koblizek V, Miravitlles M, Valipour A, Milenkovic B, Barczyk A, Somfay A, Zykov K, Kostov K, Zbozinkova Z, Svoboda M, Sorli J, Krams A, Tkacova R. GOLD 2017 on the way to a phenotypic approach? Analysis from the Phenotypes of COPD in Central and Eastern Europe (POPE) Cohort. Eur Respir J. 2017 Apr 26;49(4):1602518. doi: 10.1183/13993003.02518-2016. Print 2017 Apr. No abstract available.

    PubMed 28446560

  • Zbozinkova Z, Barczyk A, Tkacova R, Valipour A, Tudoric N, Zykov K, Somfay A, Miravitlles M, Koblizek V. POPE study: rationale and methodology of a study to phenotype patients with COPD in Central and Eastern Europe. Int J Chron Obstruct Pulmon Dis. 2016 Mar 22;11:611-22. doi: 10.2147/COPD.S88846. eCollection 2016.

    PubMed 27042048

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Obstructive Pulmonary Disease, run by Zuzana Zbožínková, M.Sc. at 81 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in Latvia, Hungary, Slovakia, Russia, Poland and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The distribution of COPD patients according to GOLD 2011 grades (time frame: 7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02119494, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2016.

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