Phenotypes of COPD in Central and Eastern Europe

Chronic Obstructive Pulmonary Disease Clinical Trial

— POPE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02119494
• Other study ID #: 205.529
• Status: Completed
• Phase: N/A
• First received: April 16, 2014
• Last updated: April 2, 2016
• Start date: June 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Masaryk University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Observational [Patient Registry]

Clinical 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. The following countries are represented in The POPE study: Czech Republic, Slovakia, Austria, Poland, Hungary, Russia, Croatia, Serbia, Slovenia, Estonia, Latvia and Bulgaria.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3504
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Austria	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	Wien
Bulgaria	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
Croatia	Clinical Hospital	Osijek
Croatia	University Hospital Centre	Rijeka
Croatia	University Hospital Centre	Split
Croatia	University Hospital Centre	Zagreb
Croatia	University Hospital Dubrava	Zagreb
Czech Republic	Pulmonary Outpatient Clinic, University Hospital Hradec Králové	Hradec Králové
Czech Republic	Plicní ambulance Karlovy Vary	Karlovy Vary
Czech Republic	Plicní ambulance Ostrava Poruba	Ostrava
Czech Republic	Plicní ambulance Teplice	Teplice
Hungary	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.	Gödöllo
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
Latvia	Health Centre Balvi	Balvi
Latvia	Bauska Hospital	Bauska
Latvia	Regional Hospital of Jekabpils	Jekabpils
Latvia	Ambulatory Clinic Jelgava	Jelgava
Latvia	Ambulatory Clinic Dubulti	Jurmala
Latvia	Kuldiga Hospital	Kuldiga
Latvia	Regional Hospital of Liepaja	Liepaja
Latvia	Madona Hospital	Madona
Latvia	Privat practice Viktorija Vevere	Rezekne
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
Poland	Oddzial Chorób Pluc i Niewydolnosci Oddychania, Kujawsko - Pomorskie; Centrum Pulmonologii w Bydgoszczy	Bydgoszcz
Poland	Klinika Alergologii i Pneumonologii, Uniwersyteckie Centrum Kliniczne, Szpital Gdanskiego Uniwersytetu Medycznego,	Gdansk
Poland	Oddzial Chorób Pluc, Wojewódzkie Centrum Szpitalne Kotliny Jeleniogórskiej,	Jelenia Góra
Poland	Katedra i Klinika Pneumonologii, Slaski Uniwersytet Medyczny	Katowice
Poland	Szpital Uniwersytecki, Oddzial 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 Wewnetrznych, Pneumonologii i Alergologii, Samodzielny Publiczny Centralny Szpital Kliniczny Warszawski Uniwersytet Medyczny,	Warsaw
Russian Federation	State Budget Educational Institution of High Professional Education "Kazan State Medical University"	Kazan
Russian Federation	I.M.Sechenov First Moscow State Medical University, University Hospital #1, Outpatient Department	Moscow
Russian Federation	Moscow State City Clinical Hospital No. 24	Moscow
Russian Federation	Moscow State University of Medicine and Dentistry named after A.I.Evdokimov	Moscow
Russian Federation	Pulmonology Research Institute	Moscow
Russian Federation	GBOU VPO Samara State Medical University	Samara
Russian Federation	Clinic of Pulmonology of Scientific and Clinical Center of Interstitial and Orphan Lung Diseases	St. Petersburg
Russian Federation	Ufa State City Clinical Hospital	Ufa
Russian Federation	Vladivostok Clinical Hospital No.1	Vladivostok
Serbia	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	Nis
Serbia	Institute for Pulmonary Diseases and TB, Clinical Centre Vojvodina	Novi Sad
Slovakia	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 respiracných chorôb JLF UK a UNM	Martin
Slovakia	Dionea, s.r.o.	Nové Zámky
Slovakia	Plúcna ambulancia	Poprad
Slovakia	NsP	Považská Bystrica
Slovakia	Zdravotné stredisko Rimava	Rimavská Sobota
Slovenia	Alveola, d.o.o.	Maribor
Slovenia	Zdravstveni dom Murska Sobota	Murska Sobota
Slovenia	Bolnišnica Topolšica	Topolšica

Sponsors (2)

Lead Sponsor	Collaborator
Zuzana Zbožínková, M.Sc.	Boehringer Ingelheim

Countries where clinical trial is conducted

Austria,  Bulgaria,  Croatia,  Czech Republic,  Hungary,  Latvia,  Poland,  Russian Federation,  Serbia,  Slovakia,  Slovenia, 

References & Publications (6)

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;11:122. doi: 10.1186/1465-9921-11-122. — View Citation

Dolan S, Varkey B. Prognostic factors in chronic obstructive pulmonary disease. Curr Opin Pulm Med. 2005 Mar;11(2):149-52. Review. — View Citation

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. Erratum in: Arch Intern Med. 2010 Jun 28;170(12):1023. — View Citation

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. — View Citation

Menn P, Heinrich J, Huber RM, Jörres 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. — View Citation

Miravitlles M, Soler-Cataluña JJ, Calle M, Molina J, Almagro P, Quintano JA, Trigueros JA, Piñera P, Simón 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	The distribution of COPD patients according to GOLD 2011 categories of risk (A. B, C, D)		7 months	No
Secondary	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	7 months	No
Secondary	The prevalence various medication prescription		7 months	No
Secondary	The prevalence of long term oxygen therapy use		7 months	No
Secondary	The prevalence of surgical treatments in COPD patients		7 months	No
Secondary	The use of body plethysmography, bronchodilator test, carbon monoxide diffusing capacity testing, bronchial challenge test and FeNO test in ambulatory care		7 months	No