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

Chronic Obstructive Airway Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01923051
• Other study ID #: 1301100001
• Secondary ID: 1301100001
• Status: Active, not recruiting
• Start date: August 2013
• Est. completion date: December 2021

Study information

• Verified date: June 2019
• Source: Masaryk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 813
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Airway Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Czechia	University Hospital Brno	Brno
Czechia	Hospital Ceske Budejovice	Ceské Budejovice
Czechia	University Hospital Hradec Kralove	Hradec Kralove
Czechia	Hospital Jihlava	Jihlava
Czechia	Regional Hospital Liberec	Liberec
Czechia	Regional hospital Mlada Boleslav	Mlada Boleslav
Czechia	University Hospital Olomouc	Olomouc
Czechia	University Hospital Ostrava	Ostrava
Czechia	EUC Klinika Plzen	Plzen
Czechia	Hospital Na Bulovce	Prague
Czechia	Thomayer Hospital	Prague
Czechia	University Hospital in Motol	Prague
Czechia	Masaryk Hospital in Usti nad Labem	Usti nad Labem
Czechia	Tomas Bata Regional Hospital	Zlin

Sponsors (1)

Lead Sponsor	Collaborator
Zuzana Zbožínková, M.Sc.

Country where clinical trial is conducted

Czechia, 

References & Publications (1)

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. eC — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Monitoring of lung function decline	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.	Outcome measures will be conducted within one year after completion.
Other	Monitoring of activity of daily living	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.	Outcome measures will be conducted within one year after completion.
Other	Monitoring of COPD categories	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.	Outcome measures will be conducted within one year after completion.
Other	Monitoring of therapeutic compliance	Regular (once a year) monitoring of inhalation technique and evaluation of Morisky Medication Adherence Scale 4 (MMAS-4).	Outcome measures will be conducted within one year after completion.
Other	Monitoring of prognostic indices	Annual monitoring of several prognostic indices (Celli´s BODE, Puhan´s BODE, ADO) and analysis of the differences in patients with specific COPD phenotypes.	Outcome measures will be conducted within one year after completion.
Other	Assessment of the extrapulmonary symptoms	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.	Outcome measures will be conducted within one year after completion.
Other	Quality of life assessment(SGRQ)	Regular (annual) evaluation of quality of life using SGRQ.	Outcome measures will be conducted within one year after completion.
Primary	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	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.

External Links

•   Czech National Research Database of COPD