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

NCT ID: NCT01923051

Last Updated: 2019-06-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 813 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2021-12-31

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

Conditions

Chronic Obstructive Airway Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zuzana Zbožínková, M.Sc.

OTHER

Sponsor Role: lead

Responsible Party

Zuzana Zbožínková, M.Sc.

Zuzana Zbozinkova PharmDr

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Vladimir Koblizek, Assoc. Prof. PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Hradec Kralove

Locations

University Hospital Brno

Brno, , Czechia

Hospital Ceske Budejovice

Ceské Budějovice, , Czechia

University Hospital Hradec Kralove

Hradec Králové, , Czechia

Hospital Jihlava

Jihlava, , Czechia

Regional Hospital Liberec

Liberec, , Czechia

Regional hospital Mlada Boleslav

Mladá Boleslav, , Czechia

University Hospital Olomouc

Olomouc, , Czechia

University Hospital Ostrava

Ostrava, , Czechia

EUC Klinika Plzen

Pilsen, , Czechia

Thomayer Hospital

Prague, , Czechia

University Hospital in Motol

Prague, , Czechia

Hospital Na Bulovce

Prague, , Czechia

Masaryk Hospital in Usti nad Labem

Ústí nad Labem, , Czechia

Tomas Bata Regional Hospital

Zlín, , Czechia

Countries

Czechia

References

Novotna B, Koblizek V, Zatloukal J, Plutinsky M, Hejduk K, Zbozinkova Z, Jarkovsky J, Sobotik O, Dvorak T, Safranek P. Czech multicenter research database of severe COPD. Int J Chron Obstruct Pulmon Dis. 2014 Nov 10;9:1265-74. doi: 10.2147/COPD.S71828. eCollection 2014.

Reference Type: RESULT

PMID: 25419124 (View on PubMed)

Brat K, Svoboda M, Hejduk K, Plutinsky M, Zatloukal J, Volakova E, Popelkova P, Novotna B, Engova D, Franssen FME, Vanfleteren LEGW, Spruit MA, Koblizek V. Introducing a new prognostic instrument for long-term mortality prediction in COPD patients: the CADOT index. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2021 Jun;165(2):139-145. doi: 10.5507/bp.2020.035. Epub 2020 Sep 10.

Reference Type: DERIVED

PMID: 32955038 (View on PubMed)

Related Links

http://chopn.registry.cz/index-en.php

Czech National Research Database of COPD

Other Identifiers

1301100001

Identifier Type: OTHER

Identifier Source: secondary_id

1301100001

Identifier Type: -

Identifier Source: org_study_id