Phenotypes of COPD in Central and Eastern Europe (POPE)
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| ClinicalTrials.gov Identifier: NCT02119494 |
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Recruitment Status :
Completed
First Posted : April 21, 2014
Last Update Posted : April 5, 2016
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| Condition or disease |
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| Chronic Obstructive Pulmonary Disease |
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 : | Observational [Patient Registry] |
| Actual Enrollment : | 3504 participants |
| Observational Model: | Cohort |
| Time Perspective: | Cross-Sectional |
| Target Follow-Up Duration: | 7 Months |
| Official Title: | POPE-Study: Phenotypes Of COPD in Central and Eastern Europe Study |
| Study Start Date : | June 2014 |
| Actual Primary Completion Date : | December 2015 |
| Actual Study Completion Date : | December 2015 |
- 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
- The distribution of COPD patients according to GOLD 2011 categories of risk (A. B, C, D) [ Time Frame: 7 months ]
- 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
- The prevalence various medication prescription [ Time Frame: 7 months ]
- The prevalence of long term oxygen therapy use [ Time Frame: 7 months ]
- The prevalence of surgical treatments in COPD patients [ Time Frame: 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 ]
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| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02119494
Show 81 study locations
| 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Zuzana Zbožínková, M.Sc., project manager, Masaryk University |
| ClinicalTrials.gov Identifier: | NCT02119494 |
| Other Study ID Numbers: |
205.529 |
| First Posted: | April 21, 2014 Key Record Dates |
| Last Update Posted: | April 5, 2016 |
| Last Verified: | April 2016 |
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chronic obstructive pulmonary disease phenotypes categories |
stage GOLD treatment |
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Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases |
Chronic Disease Disease Attributes Pathologic Processes |