Phenotypes of COPD in Central and Eastern Europe (POPE)

April 2, 2016 updated by: Zuzana Zbožínková, M.Sc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3504

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, A-6020
        • Department of Internal Medicine, University Innsbruck
      • Linz, Austria, 1090
        • AKH Linz, Department of Pulmonary Medicine
      • Mühlein, Austria
        • SKA der PV Weyer/Enns
      • Vienna, Austria, 1100
        • Pulmonary Rehabilitation Centre, Therme Wien
      • Wien, Austria
        • Ludwig Boltzmann Institute
  • Bulgaria
      • Pleven, Bulgaria
        • Clinic for pneumonology and phisiatry, UMHAT "Dr. Georgi Stranski"
      • Plovdiv, Bulgaria
        • Department of Respiratory Diseases, Medical University
      • Sofia, Bulgaria
        • Pulmonary Diseases Clinic, Military Medical Academy
      • Varna, Bulgaria
        • Clinic of Pulmonology, MHAT "st. Marina"
  • Croatia
      • Osijek, Croatia
        • Clinical Hospital
      • Rijeka, Croatia
        • University Hospital Centre
      • Split, Croatia
        • University Hospital Centre
      • Zagreb, Croatia
        • University Hospital Dubrava
      • Zagreb, Croatia
        • University Hospital Centre
  • Czech Republic
      • Hradec Králové, Czech Republic, 500 05
        • Pulmonary Outpatient Clinic, University Hospital Hradec Králové
      • Karlovy Vary, Czech Republic, 36066
        • Plicní ambulance Karlovy Vary
      • Ostrava, Czech Republic
        • Plicní ambulance Ostrava Poruba
      • Teplice, Czech Republic
        • Plicní ambulance Teplice
  • Hungary
      • Baja, Hungary
        • Baja St. Rókus Hospital Patient Lung Care Institute
      • Budapest, Hungary
        • IZO PULM Health Service Ltd.
      • Budapest, Hungary
        • Újpest Non-Profit Health Care Services Ltd.
      • Deszk, Hungary
        • Csongrád County Hospital for Chest Diseases
      • Gödöllő, Hungary
        • Elizabeth House Care Ltd.
      • Jászberény, Hungary
        • St. Elizabeth Hospital Pulmonary Care Institute
      • Nyíregyháza, Hungary
        • Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital
      • Pécs, Hungary
        • Federated Institutes of Health Institute of Pulmonary Care
      • Szarvas, Hungary
        • Szarvas Respiratory Ltd.
      • Érd, Hungary
        • Medical Institution of Dr. Laszlo Romics Pulmonary Care
  • Latvia
      • Balvi, Latvia
        • Health Centre Balvi
      • Bauska, Latvia
        • Bauska Hospital
      • Jekabpils, Latvia
        • Regional Hospital of Jekabpils
      • Jelgava, Latvia
        • Ambulatory Clinic Jelgava
      • Jurmala, Latvia
        • Ambulatory Clinic Dubulti
      • Kuldīga, Latvia
        • Kuldīga Hospital
      • Liepaja, Latvia
        • Regional Hospital of Liepaja
      • Madona, Latvia
        • Madona Hospital
      • Rezekne, Latvia
        • Privat practice Viktorija Vevere
      • Riga, Latvia
        • Pauls Stradins Clinical University Hospital
      • Riga, Latvia
        • Riga 1st Hospital
      • Riga, Latvia
        • Health Centre 4, Ltd
      • Riga, Latvia
        • LU MPI Institute privat practice
      • Riga, Latvia
        • Riga East Clinical University Hospital, In-patient Department "Centre of Tuberculosis and Lung Diseases
      • Riga, Latvia
        • UniClinic
      • Talsi, Latvia
        • Health centre
      • Valka, Latvia
        • rivat practice Ilona Uzbeka
      • Valmiera, Latvia
        • Privat practice Dace Harasimjuka
      • Ventspils, Latvia
        • Sia "Bini"
  • Poland
      • Bydgoszcz, Poland, 85-326
        • Oddział Chorób Płuc i Niewydolności Oddychania, Kujawsko - Pomorskie; Centrum Pulmonologii w Bydgoszczy
      • Gdansk, Poland, 80-211
        • Klinika Alergologii i Pneumonologii, Uniwersyteckie Centrum Kliniczne, Szpital Gdańskiego Uniwersytetu Medycznego,
      • Jelenia Góra, Poland, 58-506
        • Oddział Chorób Płuc, Wojewódzkie Centrum Szpitalne Kotliny Jeleniogórskiej,
      • Katowice, Poland, 40-752
        • Katedra i Klinika Pneumonologii, Śląski Uniwersytet Medyczny
      • Krakow, Poland, 31-066
        • Szpital Uniwersytecki, Oddział Kliniczny Kliniki Pulmonologii
      • Poznan, Poland, 60-569
        • Katedra i Klinika Pulmonologii, Alergologii i Onkologii Pulmonologicznej, Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu
      • Warsaw, Poland, 02-097
        • Katedra i Klinika Chorób Wewnętrznych, Pneumonologii i Alergologii, Samodzielny Publiczny Centralny Szpital Kliniczny Warszawski Uniwersytet Medyczny,
  • Russian Federation
      • Kazan, Russian Federation
        • State Budget Educational Institution of High Professional Education "Kazan State Medical University"
      • Moscow, 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
      • Samara, Russian Federation
        • GBOU VPO Samara State Medical University
      • St. Petersburg, Russian Federation
        • Clinic of Pulmonology of Scientific and Clinical Center of Interstitial and Orphan Lung Diseases
      • Ufa, Russian Federation
        • Ufa State City Clinical Hospital
      • Vladivostok, Russian Federation
        • Vladivostok Clinical Hospital No.1
  • Serbia
      • Belgrade, Serbia
        • Clinic for Pulmonary Diseases, Clinical Centre of Serbia
      • Belgrade, Serbia
        • Municipal Institute for lung diseases and tuberculosis
      • Kragujevac, Serbia
        • Clinic for Pulmonary Diseases, Clinical Centre Kragujevac
      • Nis, Serbia
        • Clinic for Pulmonary Diseases, Clinical Center of Nis
      • Novi Sad, Serbia
        • Institute for Pulmonary Diseases and TB, Clinical Centre Vojvodina
  • Slovakia
      • Banská Bystrica, Slovakia, 97517
        • FNsP F.D. Roosevelta
      • Bardejov, Slovakia, 085 01
        • NsP Sv. Jakuba
      • Bratislava, Slovakia, 821 01
        • Klinika pneumológie a ftizeológie LF SZU a UNB,
      • Bratislava, Slovakia, 85101
        • Zdravotné stredisko Fedinova
      • Levice, Slovakia, 934 01
        • Ambulancia pneumológie a ftizeológie, ZAPA JJ s.r.o.,
      • Martin, Slovakia, 036 59
        • Klinika tubekulózy a respiračných chorôb JLF UK a UNM
      • Nové Zámky, Slovakia, 94001
        • Dionea, s.r.o.
      • Poprad, Slovakia, 05801
        • Plucna ambulancia
      • Považská Bystrica, Slovakia, 017 26
        • NsP
      • Rimavská Sobota, Slovakia, 979 01
        • Zdravotné stredisko Rimava
  • Slovenia
      • Maribor, Slovenia, 3326
        • Alveola, d.o.o.
      • Murska Sobota, Slovenia, 9000
        • Zdravstveni dom Murska Sobota
      • Topolšica, Slovenia, 3326
        • Bolnišnica Topolšica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The distribution of COPD patients according to GOLD 2011 grades
Time Frame: 7 months
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)
Time Frame: 7 months
7 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The prevalence of various COPD phenotypes
Time Frame: 7 months
The COPD phenotypes are: bronchitis, emphysema phenotype, frequent exacerbators, pulmonary cachexia, COPD and asthma overlap, and COPD and bronchiectasis overlap
7 months
The prevalence various medication prescription
Time Frame: 7 months
7 months
The prevalence of long term oxygen therapy use
Time Frame: 7 months
7 months
The prevalence of surgical treatments in COPD patients
Time Frame: 7 months
7 months
The use of body plethysmography, bronchodilator test, carbon monoxide diffusing capacity testing, bronchial challenge test and FeNO test in ambulatory care
Time Frame: 7 months
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zuzana Zbožínková, M.Sc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Boehringer Ingelheim

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 205.529

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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