Clinical trial NCT02119494: Phenotypes of COPD in Central and Eastern Europe
Official title: POPE-Study: Phenotypes Of COPD in Central and Eastern Europe Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: chronic obstructive pulmonary disease
phenotypes
categories
stage
GOLD
treatment
Lead sponsor: Masaryk University
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
First posted: 2014-04-21
Enrollment: 3504
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with COPD who visit selected specialised pulmonology clinics in the given time period.

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.

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

Primary outcomes:
measure: The distribution of COPD patients according to GOLD 2011 grades
timeFrame: 7 months
measure: The distribution of COPD patients according to GOLD 2011 categories of risk (A. B, C, D)
timeFrame: 7 months
Secondary outcomes:
measure: The prevalence of various COPD phenotypes
timeFrame: 7 months
measure: The prevalence various medication prescription
timeFrame: 7 months
measure: The prevalence of long term oxygen therapy use
timeFrame: 7 months
measure: The prevalence of surgical treatments in COPD patients
timeFrame: 7 months
measure: The use of body plethysmography, bronchodilator test, carbon monoxide diffusing capacity testing, bronchial challenge test and FeNO test in ambulatory care
timeFrame: 7 months
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Department of Internal Medicine, University Innsbruck
city: Linz
country: Austria
facility: AKH Linz, Department of Pulmonary Medicine
city: Mühlein
country: Austria
facility: SKA der PV Weyer/Enns
city: Vienna
country: Austria
facility: Pulmonary Rehabilitation Centre, Therme Wien
city: Wien
country: Austria
facility: Ludwig Boltzmann Institute
city: Pleven
country: Bulgaria
facility: Clinic for pneumonology and phisiatry, UMHAT "Dr. Georgi Stranski"
city: Plovdiv
country: Bulgaria
facility: Department of Respiratory Diseases, Medical University
city: Sofia
country: Bulgaria
facility: Pulmonary Diseases Clinic, Military Medical Academy
city: Varna
country: Bulgaria
facility: Clinic of Pulmonology, MHAT "st. Marina"
city: Osijek
country: Croatia
facility: Clinical Hospital
city: Rijeka
country: Croatia
facility: University Hospital Centre
city: Split
country: Croatia
facility: University Hospital Centre
city: Zagreb
country: Croatia
facility: University Hospital Centre
city: Zagreb
country: Croatia
facility: University Hospital Dubrava
city: Hradec Králové
country: Czech Republic
facility: Pulmonary Outpatient Clinic, University Hospital Hradec Králové
city: Karlovy Vary
country: Czech Republic
facility: Plicní ambulance Karlovy Vary
city: Ostrava
country: Czech Republic
facility: Plicní ambulance Ostrava Poruba
city: Teplice
country: Czech Republic
facility: Plicní ambulance Teplice
city: Baja
country: Hungary
facility: Baja St. Rókus Hospital Patient Lung Care Institute
city: Budapest
country: Hungary
facility: IZO PULM Health Service Ltd.
city: Budapest
country: Hungary
facility: Újpest Non-Profit Health Care Services Ltd.
city: Deszk
country: Hungary
facility: Csongrád County Hospital for Chest Diseases
city: Gödöllő
country: Hungary
facility: Elizabeth House Care Ltd.
city: Jászberény
country: Hungary
facility: St. Elizabeth Hospital Pulmonary Care Institute
city: Nyíregyháza
country: Hungary
facility: Szabolcs-Szatmár-Bereg County Hospitals and University Teaching Hospital
city: Pécs
country: Hungary
facility: Federated Institutes of Health Institute of Pulmonary Care
city: Szarvas
country: Hungary
facility: Szarvas Respiratory Ltd.
city: Érd
country: Hungary
facility: Medical Institution of Dr. Laszlo Romics Pulmonary Care
city: Balvi
country: Latvia
facility: Health Centre Balvi
city: Bauska
country: Latvia
facility: Bauska Hospital
city: Jekabpils
country: Latvia
facility: Regional Hospital of Jekabpils
city: Jelgava
country: Latvia
facility: Ambulatory Clinic Jelgava
city: Jurmala
country: Latvia
facility: Ambulatory Clinic Dubulti
city: Kuldīga
country: Latvia
facility: Kuldīga Hospital
city: Liepaja
country: Latvia
facility: Regional Hospital of Liepaja
city: Madona
country: Latvia
facility: Madona Hospital
city: Rezekne
country: Latvia
facility: Privat practice Viktorija Vevere
city: Riga
country: Latvia
facility: Health Centre 4, Ltd
city: Riga
country: Latvia
facility: LU MPI Institute privat practice
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Riga
country: Latvia
facility: Riga 1st Hospital
city: Riga
country: Latvia
facility: Riga East Clinical University Hospital, In-patient Department "Centre of Tuberculosis and Lung Diseases
city: Riga
country: Latvia
facility: UniClinic
city: Talsi
country: Latvia
facility: Health Centre
city: Valka
country: Latvia
facility: rivat practice Ilona Uzbeka
city: Valmiera
country: Latvia
facility: Privat practice Dace Harasimjuka
city: Ventspils
country: Latvia
facility: Sia "Bini"
city: Bydgoszcz
country: Poland
facility: Oddział Chorób Płuc i Niewydolności Oddychania, Kujawsko - Pomorskie; Centrum Pulmonologii w Bydgoszczy
city: Gdansk
country: Poland
facility: Klinika Alergologii i Pneumonologii, Uniwersyteckie Centrum Kliniczne, Szpital Gdańskiego Uniwersytetu Medycznego,
city: Jelenia Góra
country: Poland
facility: Oddział Chorób Płuc, Wojewódzkie Centrum Szpitalne Kotliny Jeleniogórskiej,
city: Katowice
country: Poland
facility: Katedra i Klinika Pneumonologii, Śląski Uniwersytet Medyczny
city: Krakow
country: Poland
facility: Szpital Uniwersytecki, Oddział Kliniczny Kliniki Pulmonologii
city: Poznan
country: Poland
facility: Katedra i Klinika Pulmonologii, Alergologii i Onkologii Pulmonologicznej, Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu
city: Warsaw
country: Poland
facility: Katedra i Klinika Chorób Wewnętrznych, Pneumonologii i Alergologii, Samodzielny Publiczny Centralny Szpital Kliniczny Warszawski Uniwersytet Medyczny,
city: Kazan
country: Russian Federation
facility: State Budget Educational Institution of High Professional Education "Kazan State Medical University"
city: Moscow
country: Russian Federation
facility: I.M.Sechenov First Moscow State Medical University, University Hospital #1, Outpatient Department
city: Moscow
country: Russian Federation
facility: Moscow State City Clinical Hospital No. 24
city: Moscow
country: Russian Federation
facility: Moscow State University of Medicine and Dentistry named after A.I.Evdokimov
city: Moscow
country: Russian Federation
facility: Pulmonology Research Institute
city: Samara
country: Russian Federation
facility: GBOU VPO Samara State Medical University
city: St. Petersburg
country: Russian Federation
facility: Clinic of Pulmonology of Scientific and Clinical Center of Interstitial and Orphan Lung Diseases
city: Ufa
country: Russian Federation
facility: Ufa State City Clinical Hospital
city: Vladivostok
country: Russian Federation
facility: Vladivostok Clinical Hospital No.1
city: Belgrade
country: Serbia
facility: Clinic for Pulmonary Diseases, Clinical Centre of Serbia
city: Belgrade
country: Serbia
facility: Municipal Institute for Lung Diseases and Tuberculosis
city: Kragujevac
country: Serbia
facility: Clinic for Pulmonary Diseases, Clinical Centre Kragujevac
city: Nis
country: Serbia
facility: Clinic for Pulmonary Diseases, Clinical Center of Nis
city: Novi Sad
country: Serbia
facility: Institute for Pulmonary Diseases and TB, Clinical Centre Vojvodina
city: Banská Bystrica
country: Slovakia
facility: FNsP F.D. Roosevelta
city: Bardejov
country: Slovakia
facility: NsP Sv. Jakuba
city: Bratislava
country: Slovakia
facility: Klinika pneumológie a ftizeológie LF SZU a UNB,
city: Bratislava
country: Slovakia
facility: Zdravotné stredisko Fedinova
city: Levice
country: Slovakia
facility: Ambulancia pneumológie a ftizeológie, ZAPA JJ s.r.o.,
city: Martin
country: Slovakia
facility: Klinika tubekulózy a respiračných chorôb JLF UK a UNM
city: Nové Zámky
country: Slovakia
facility: Dionea, s.r.o.
city: Poprad
country: Slovakia
facility: Pľúcna ambulancia
city: Považská Bystrica
country: Slovakia
facility: NsP
city: Rimavská Sobota
country: Slovakia
facility: Zdravotné stredisko Rimava
city: Maribor
country: Slovenia
facility: Alveola, d.o.o.
city: Murska Sobota
country: Slovenia
facility: Zdravstveni dom Murska Sobota
city: Topolšica
country: Slovenia
facility: Bolnišnica Topolšica
Study officials:
affiliation: Vienna Hospital Association
name: Arschang Valipour, Assoc. Prof., MD, PhD
role: STUDY_DIRECTOR
affiliation: University Hospital Hradec Kralove
name: Vladimir Koblizek, MD, Ph.D
role: STUDY_DIRECTOR
affiliation: Pavol Jozef Šafárik University in Košice
name: Ruzena Tkacova, Prof., MD, PhD
role: STUDY_DIRECTOR
affiliation: University of Zagreb, Clinical Hospital Dubrava
name: Neven Tudoric, Prof., MD, Ph.D
role: STUDY_DIRECTOR
affiliation: Moscow State University of Medicine and Dentistry
name: Kyrill Zykov, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of Szeged, Faculty of Medicine, Dept. of Pulmonology
name: Attila Somfay, Prof., MD, PhD
role: STUDY_DIRECTOR
affiliation: Katedra i Klinika Pneumonologii, Śląski Uniwersytet Medyczny
name: Adam Barczyk, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Universitari Vall d'hebron Barcelona, Spain
name: Marc Miravitlles, Prof., MD, PhD
role: STUDY_DIRECTOR
References:
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.
citation: 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.
citation: 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.
citation: 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.
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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.