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Phenotypes of COPD in Central and Eastern Europe (POPE)

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ClinicalTrials.gov Identifier: NCT02119494
Recruitment Status : Completed
First Posted : April 21, 2014
Last Update Posted : April 5, 2016
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Zuzana Zbožínková, M.Sc., Masaryk University

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.

Condition or disease
Chronic Obstructive Pulmonary Disease

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 : 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
Primary Completion Date : December 2015
Study Completion Date : December 2015



Primary Outcome Measures :
  1. 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

  2. The distribution of COPD patients according to GOLD 2011 categories of risk (A. B, C, D) [ Time Frame: 7 months ]

Secondary Outcome Measures :
  1. 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

  2. The prevalence various medication prescription [ Time Frame: 7 months ]
  3. The prevalence of long term oxygen therapy use [ Time Frame: 7 months ]
  4. The prevalence of surgical treatments in COPD patients [ Time Frame: 7 months ]
  5. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with COPD who visit selected specialised pulmonology clinics in the given time period.
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

Information from the National Library of Medicine

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
Sponsors and Collaborators
Zuzana Zbožínková, M.Sc.
Boehringer Ingelheim
Investigators
Study Director: Arschang Valipour, Assoc. Prof., MD, PhD Wiener Krankenanstaltenverbund
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     History of Changes
Other Study ID Numbers: 205.529
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: April 5, 2016
Last Verified: April 2016

Keywords provided by Zuzana Zbožínková, M.Sc., Masaryk University:
chronic obstructive pulmonary disease
phenotypes
categories
stage
GOLD
treatment

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases