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

NCT01923051 | Unknown

• 1 other identifier: 1301100001
• Study Type: observational
• Target: 813
• Locations: 1 country
• Sites: 14

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.

Conditions

Chronic Obstructive Airway Disease

Keywords

chronic obstructive pulmonary disease; COPD; national database; observational

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assessment of morbidity

  Outcome measures will be conducted within one year after completion.

Other Outcomes (7)

• Monitoring of lung function decline

  Outcome measures will be conducted within one year after completion.

• Monitoring of activity of daily living

  Outcome measures will be conducted within one year after completion.

• Monitoring of COPD categories

  Outcome measures will be conducted within one year after completion.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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 an unselected population of COPD patients in long lasting care of individual participating centres. Each centre covers the population of a certain county. The centres are localized as to symetrically cover the entire Czech Republic.

You may qualify if:

• 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

You may not qualify if:

• "Pure" bronchial asthma without COPD
• "Pure" bronchiectasis without COPD
• Cystic fibrosis
• End-stage of COPD
• Non-curable malignancy
• Total non-compliance
• Immobility

Sponsors & Collaborators

• Zuzana Zbožínková, M.Sc.: lead

Study Sites (14)

University Hospital Brno

Brno, 625 00, Czechia

Location

Hospital Ceske Budejovice

Ceské Budějovice, Czechia

Location

University Hospital Hradec Kralove

Hradec Králové, 500 05, Czechia

Location

Hospital Jihlava

Jihlava, 586 33, Czechia

Location

Regional Hospital Liberec

Liberec, 460 63, Czechia

Location

Regional hospital Mlada Boleslav

Mladá Boleslav, Czechia

Location

University Hospital Olomouc

Olomouc, 775 20, Czechia

Location

University Hospital Ostrava

Ostrava, 708 52, Czechia

Location

EUC Klinika Plzen

Pilsen, 301 00, Czechia

Location

Thomayer Hospital

Prague, 140 59, Czechia

Location

University Hospital in Motol

Prague, 150 06, Czechia

Location

Hospital Na Bulovce

Prague, 180 81, Czechia

Location

Masaryk Hospital in Usti nad Labem

Ústí nad Labem, 401 13, Czechia

Location

Tomas Bata Regional Hospital

Zlín, 760 01, Czechia

Location

Related Publications (2)

• 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.

  PMID: 25419124 RESULT

• 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.

  PMID: 32955038 DERIVED

Related Links

• Czech National Research Database of COPD

Biospecimen

Retention: SAMPLES WITH DNA

In the following centres, we will be collecting samples with DNA (blood samples): University Hospital Olomouc, University Hospital Hradec Kralove, University Hospital Motol, University Hospital Brno.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vladimir Koblizek, Assoc. Prof. PhD

  University Hospital Hradec Kralove

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Zuzana Zbozinkova PharmDr

Study Record Dates

• First Submitted: August 7, 2013
• First Posted: August 14, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: June 13, 2019

Record last verified: 2019-06

Locations

CZ (14)