Phenotypes of COPD in Central and Eastern Europe

NCT02119494 | Completed DMC

• 1 other identifier: 205.529
• Study Type: observational
• Target: 3,504
• Locations: 10 countries
• Sites: 78

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

chronic obstructive pulmonary disease; phenotypes; categories; stage; GOLD; treatment

Outcome Measures

Primary Outcomes (2)

• 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

  7 months

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

  7 months

Secondary Outcomes (5)

• The prevalence of various COPD phenotypes

  7 months

• The prevalence various medication prescription

  7 months

• The prevalence of long term oxygen therapy use

  7 months

• The prevalence of surgical treatments in COPD patients

  7 months

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

  7 months

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zuzana Zbožínková, M.Sc.: lead
• Boehringer Ingelheim: collaborator

Study Sites (81)

Department of Internal Medicine, University Innsbruck

Innsbruck, A-6020, Austria

Location

AKH Linz, Department of Pulmonary Medicine

Linz, 1090, Austria

Location

SKA der PV Weyer/Enns

Mühlein, Austria

Location

Pulmonary Rehabilitation Centre, Therme Wien

Vienna, 1100, Austria

Location

Ludwig Boltzmann Institute

Vienna, Austria

Location

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

Pleven, Bulgaria

Location

Department of Respiratory Diseases, Medical University

Plovdiv, Bulgaria

Location

Pulmonary Diseases Clinic, Military Medical Academy

Sofia, Bulgaria

Location

Clinic of Pulmonology, MHAT "st. Marina"

Varna, Bulgaria

Location

Clinical Hospital

Osijek, Croatia

Location

University Hospital Centre

Rijeka, Croatia

Location

University Hospital Centre

Split, Croatia

Location

University Hospital Centre

Zagreb, Croatia

Location

University Hospital Dubrava

Zagreb, Croatia

Location

Pulmonary Outpatient Clinic, University Hospital Hradec Králové

Hradec Králové, 500 05, Czechia

Location

Plicní ambulance Karlovy Vary

Karlovy Vary, 36066, Czechia

Location

Plicní ambulance Ostrava Poruba

Ostrava, Czechia

Location

Plicní ambulance Teplice

Teplice, Czechia

Location

Baja St. Rókus Hospital Patient Lung Care Institute

Baja, Hungary

Location

IZO PULM Health Service Ltd.

Budapest, Hungary

Location

Újpest Non-Profit Health Care Services Ltd.

Budapest, Hungary

Location

Csongrád County Hospital for Chest Diseases

Deszk, Hungary

Location

Medical Institution of Dr. Laszlo Romics Pulmonary Care

Érd, Hungary

Location

Elizabeth House Care Ltd.

Gödöllő, Hungary

Location

St. Elizabeth Hospital Pulmonary Care Institute

Jászberény, Hungary

Location

Szabolcs-Szatmár-Bereg County Hospitals and University Teaching Hospital

Nyíregyháza, Hungary

Location

Federated Institutes of Health Institute of Pulmonary Care

Pécs, Hungary

Location

Szarvas Respiratory Ltd.

Szarvas, Hungary

Location

Health Centre Balvi

Balvi, Latvia

Location

Bauska Hospital

Bauska, Latvia

Location

Ambulatory Clinic Jelgava

Jelgava, Latvia

Location

Regional Hospital of Jekabpils

Jēkabpils, Latvia

Location

Ambulatory Clinic Dubulti

Jūrmala, Latvia

Location

Kuldīga Hospital

Kuldīga, Latvia

Location

Regional Hospital of Liepaja

Liepāja, Latvia

Location

Madona Hospital

Madona, Latvia

Location

Privat practice Viktorija Vevere

Rēzekne, Latvia

Location

Health Centre 4, Ltd

Riga, Latvia

Location

LU MPI Institute privat practice

Riga, Latvia

Location

Pauls Stradins Clinical University Hospital

Riga, Latvia

Location

Riga 1st Hospital

Riga, Latvia

Location

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

Riga, Latvia

Location

UniClinic

Riga, Latvia

Location

Health Centre

Talsi, Latvia

Location

rivat practice Ilona Uzbeka

Valka, Latvia

Location

Privat practice Dace Harasimjuka

Valmiera, Latvia

Location

Sia "Bini"

Ventspils, Latvia

Location

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

Bydgoszcz, 85-326, Poland

Location

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

Gdansk, 80-211, Poland

Location

Oddział Chorób Płuc, Wojewódzkie Centrum Szpitalne Kotliny Jeleniogórskiej,

Jelenia Góra, 58-506, Poland

Location

Katedra i Klinika Pneumonologii, Śląski Uniwersytet Medyczny

Katowice, 40-752, Poland

Location

Szpital Uniwersytecki, Oddział Kliniczny Kliniki Pulmonologii

Krakow, 31-066, Poland

Location

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

Poznan, 60-569, Poland

Location

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

Warsaw, 02-097, Poland

Location

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

Kazan', Russia

Location

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

Moscow, Russia

Location

Moscow State City Clinical Hospital No. 24

Moscow, Russia

Location

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

Moscow, Russia

Location

Pulmonology Research Institute

Moscow, Russia

Location

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

Saint Petersburg, Russia

Location

GBOU VPO Samara State Medical University

Samara, Russia

Location

Ufa State City Clinical Hospital

Ufa, Russia

Location

Vladivostok Clinical Hospital No.1

Vladivostok, Russia

Location

Clinic for Pulmonary Diseases, Clinical Centre of Serbia

Belgrade, Serbia

Location

Municipal Institute for Lung Diseases and Tuberculosis

Belgrade, Serbia

Location

Clinic for Pulmonary Diseases, Clinical Centre Kragujevac

Kragujevac, Serbia

Location

Clinic for Pulmonary Diseases, Clinical Center of Nis

Niš, Serbia

Location

Institute for Pulmonary Diseases and TB, Clinical Centre Vojvodina

Novi Sad, Serbia

Location

FNsP F.D. Roosevelta

Banská Bystrica, 97517, Slovakia

Location

NsP Sv. Jakuba

Bardejov, 085 01, Slovakia

Location

Klinika pneumológie a ftizeológie LF SZU a UNB,

Bratislava, 821 01, Slovakia

Location

Zdravotné stredisko Fedinova

Bratislava, 85101, Slovakia

Location

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

Levice, 934 01, Slovakia

Location

Klinika tubekulózy a respiračných chorôb JLF UK a UNM

Martin, 036 59, Slovakia

Location

Dionea, s.r.o.

Nové Zámky, 94001, Slovakia

Location

Pľúcna ambulancia

Poprad, 05801, Slovakia

Location

NsP

Považská Bystrica, 017 26, Slovakia

Location

Zdravotné stredisko Rimava

Rimavská Sobota, 979 01, Slovakia

Location

Alveola, d.o.o.

Maribor, 3326, Slovenia

Location

Zdravstveni dom Murska Sobota

Murska Sobota, 9000, Slovenia

Location

Bolnišnica Topolšica

Topolšica, 3326, Slovenia

Location

Related Publications (9)

• 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.

  PMID: 20308643 BACKGROUND

• 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.

  PMID: 22100535 BACKGROUND

• 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.

  PMID: 15699788 BACKGROUND

• 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.

  PMID: 20831787 BACKGROUND

• 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.

  PMID: 20522794 BACKGROUND

• 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.

  PMID: 23443227 BACKGROUND

• 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.

  PMID: 30961941 DERIVED

• 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.

  PMID: 28446560 DERIVED

• 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.

  PMID: 27042048 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arschang Valipour, Assoc. Prof., MD, PhD

  Vienna Hospital Association

  STUDY DIRECTOR

• Vladimir Koblizek, MD, Ph.D

  University Hospital Hradec Kralove

  STUDY DIRECTOR

• Ruzena Tkacova, Prof., MD, PhD

  Pavol Jozef Šafárik University in Košice

  STUDY DIRECTOR

• Neven Tudoric, Prof., MD, Ph.D

  University of Zagreb, Clinical Hospital Dubrava

  STUDY DIRECTOR

• Kyrill Zykov, MD, PhD

  Moscow State University of Medicine and Dentistry

  STUDY DIRECTOR

• Attila Somfay, Prof., MD, PhD

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

  STUDY DIRECTOR

• Adam Barczyk, MD, PhD

  Katedra i Klinika Pneumonologii, Śląski Uniwersytet Medyczny

  STUDY DIRECTOR

• Marc Miravitlles, Prof., MD, PhD

  Hospital Universitari Vall d'hebron Barcelona, Spain

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 7 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: project manager

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: April 21, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 5, 2016

Record last verified: 2016-04

Locations

SL (10); CR (5); CZ (4); PL (7); AU (5); BU (4); LA (19); HU (10); RU (9); SE (5)