Phenotypes of COPD in Central and Eastern Europe
- Conditions
- Chronic Obstructive Pulmonary Disease
- Registration Number
- NCT02119494
- Lead Sponsor
- Zuzana Zbožínková, M.Sc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3504
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The distribution of COPD patients according to GOLD 2011 grades 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
The distribution of COPD patients according to GOLD 2011 categories of risk (A. B, C, D) 7 months
- Secondary Outcome Measures
Name Time Method The prevalence of surgical treatments in COPD patients 7 months The prevalence various medication prescription 7 months The prevalence of various COPD phenotypes 7 months The COPD phenotypes are: bronchitis, emphysema phenotype, frequent exacerbators, pulmonary cachexia, COPD and asthma overlap, and COPD and bronchiectasis overlap
The prevalence of long term oxygen therapy use 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
Trial Locations
- Locations (79)
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, Austria
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, Bulgaria
Clinical Hospital
🇭🇷Osijek, Croatia
Scroll for more (69 remaining)Department of Internal Medicine, University Innsbruck🇦🇹Innsbruck, Austria