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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01923051
Enrollment
813
Registered
2013-08-14
Start date
2013-08-31
Completion date
2021-12-31
Last updated
2019-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Airway Disease

Keywords

chronic obstructive pulmonary disease, COPD, national database, observational

Brief summary

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

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

Interventions

None listed

Sponsors

Zuzana Zbožínková, M.Sc.
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of all-cause mortalityOutcome measures will be conducted within one year after completion.Assessment of all-cause mortality in an unselected group of consecutive patients with severe COPD (post-bronchodilator FEV1 ≤ 60%).

Secondary

MeasureTime frameDescription
Assessment of morbidityOutcome measures will be conducted within one year after completion.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%).

Other

MeasureTime frameDescription
Monitoring of activity of daily livingOutcome measures will be conducted within one year after completion.Measurement of daily activity using pedometers (each participating patient will be monitored for one month, every year) and analysis of the differences in patients with specific COPD phenotypes.
Monitoring of COPD categoriesOutcome measures will be conducted within one year after completion.Assessment of the variability in COPD categories (A-D categories will be calculated twice a year) over a 5 year follow-up and analysis of the differences in patients with specific COPD phenotypes.
Monitoring of therapeutic complianceOutcome measures will be conducted within one year after completion.Regular (once a year) monitoring of inhalation technique and evaluation of Morisky Medication Adherence Scale 4 (MMAS-4).
Monitoring of prognostic indicesOutcome measures will be conducted within one year after completion.Annual monitoring of several prognostic indices (Celli´s BODE, Puhan´s BODE, ADO) and analysis of the differences in patients with specific COPD phenotypes.
Assessment of the extrapulmonary symptomsOutcome measures will be conducted within one year after completion.Monitoring of the extrapulmonary impairment (Beck depression scale, Zung depression scale, SNOT-22, densitometry, cardiology history, ECG and cardiac ultrasound) and analysis of the differences in subjects with specific COPD phenotypes.
Quality of life assessment(SGRQ)Outcome measures will be conducted within one year after completion.Regular (annual) evaluation of quality of life using SGRQ.
Monitoring of lung function declineOutcome measures will be conducted within one year after completion.Monitoring of lung function decline (post-bronchodilator FEV1 will be measured twice a year) and analysis of the differences in patients with specific COPD phenotypes.

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026