Czech Multicentre Research Database of Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
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Brief Summary
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The chronic obstructive pulmonary disease (COPD) is the occurrence of chronic bronchitis or emphysema, a pair of commonly co-existing diseases of the lungs in which the airways narrow over time. This limits airflow to and from the lungs, causing shortness of breath (dyspnoea). In clinical practice, COPD is defined by its characteristic airflow limitation on lung function tests. In contrast to asthma, this limitation is poorly reversible and usually gets increasingly worse over time. The COPD registry is a non-interventional multicentre observational prospective database focusing on the collection and analysis of data on real mortality and morbidity in COPD population of the Czech Republic population of COPD patients. Monitoring is done at the occasion of regular check-ups, followed by retrospective search of data in the documentation, and a record into the registry. The aim of Czech National Research Database of Chronic Obstructive Pulmonary Disease is to establish the clinical course of severe forms of COPD, establish the cause for deterioration of clinical status of our patients and describe the progression of COPD to death. The registry fulfils general objectives of health registries such as monitoring of causes, development, treatment and consequences of a severe disorder, including economic and social impacts. Statistical and scientific analyses of the registry data are focused, in particular, on the assessment of health determiners of the selected patient cohort with the aim to improve health status of the patients.

Detailed Description
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Chronic Obstructive Pulmonary Disease (COPD) is a treatable and preventable clinically heterogeneous syndrome with dominant respiratory symptoms and various systemic consequences. The incidence of COPD is increasing worldwide. In general, COPD is caused by a prolonged inflammatory reaction of a genetically predisposed individual exposed to long-term inhalation of air pollution, harmful particles and gases. This disease has a negative progression in time even after end of exposure. The pulmonary component is associated with expiratory airflow limitation, which is not fully reversible. The airflow limitation in COPD develops gradually as a result of chronic, primarily non-infectious inflammation of the airways and lung parenchyma. Systemic consequences are often found in cardiovascular, musculoskeletal and other systems. COPD can be considered a proven pre-cancerous condition. Up-to-date and precise clinical and epidemiological data describing the situation in the Czech Republic is currently unavailable. The Czech Republic still does not have any data on representation of different phenotypes among COPD patients. The COPD Register is a non-interventional multicenter observational prospective database focusing on the collection and analysis of data on real mortality and morbidity in an unselected (consecutive) population of patients with severe forms of COPD (post-bronchodilator FEV1≤ 60%). Monitoring is done at the occasion of regular check-ups, followed by retrospective search of data in the documentation, and a record into the registry subsequently. The main purposes of this study: Assessment of all-cause mortality Assessment of morbidity: (A) acute exacerbation of COPD (B) acute non-COPD respiratory events (C) acute non-respiratory events (D) cancers (E) ischemic heart disease (infarct, angina pectoris, congestive heart failure and arrhythmia) Other aims of this study: Monitoring of lung function decline (post-bronchodilator FEV1) Monitoring of prognostic indices COPD categories and quality of life Evaluation of activity of daily living Assessment of therapeutic compliance Note: MMAS-4 questionnaire by Prof. Donald E. Morisky will not be used as of September 2018 Analysis of extra-pulmonary impairment during

Official Title
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Czech Multicentre Research Database of Chronic Obstructive Pulmonary Disease (COPD): Registry of the Czech Pneumological Society (CPPS) at the Czech Medical Association (CzMA)

Conditions
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Chronic Obstructive Airway Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post-bronchodilator FEV1/VC < LLN and post-bronchodilator FEV1 ≤ 60% of the predicted value (VC - Vital Capacity, LLN - Lower Limit of Normal) Definite clinical diagnosis of COPD (can be overlaps: COPD + asthma / COPD + bronchiectasis) Stable course of COPD (≥ 8 weeks free of acute exacerbations and/or free of any acute conditions) Informed consent Exclusion Criteria: Pure bronchial asthma without COPD Pure bronchiectasis without COPD Cystic fibrosis End-stage of COPD Non-curable malignancy Total non-compliance Immobility

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of all-cause mortality | Assessment of all-cause mortality in an unselected group of consecutive patients with severe COPD (post-bronchodilator FEV1 ≤ 60%). | Outcome measures will be conducted within one year after completion. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of morbidity | Assessment of morbidity: (A) acute exacerbation of COPD, (B) acute non-COPD respiratory events, (C) acute non-respiratory events, (D) cancers, (E) ischemic heart disease (myocardial infarct, angina pectoris, congestive heart failure and arrhythmia) in an unselected group of consecutive patients with severe COPD (post-bronchodilator FEV1 ≤ 60%). | Outcome measures will be conducted within one year after completion. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic obstructive pulmonary disease, COPD, national database, observational