Clinical trial NCT01923051: Czech Multicentre Research Database of Chronic Obstructive Pulmonary Disease (COPD)
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Airway Disease
Keywords: chronic obstructive pulmonary disease
COPD
national database
observational
Lead sponsor: Masaryk University
Sponsor class: OTHER
First posted: 2013-08-14
Enrollment: 813
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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

Primary outcomes:
measure: Assessment of all-cause mortality
timeFrame: Outcome measures will be conducted within one year after completion.
Secondary outcomes:
measure: Assessment of morbidity
timeFrame: Outcome measures will be conducted within one year after completion.
Other outcomes:
measure: Monitoring of lung function decline
timeFrame: Outcome measures will be conducted within one year after completion.
measure: Monitoring of activity of daily living
timeFrame: Outcome measures will be conducted within one year after completion.
measure: Monitoring of COPD categories
timeFrame: Outcome measures will be conducted within one year after completion.
measure: Monitoring of therapeutic compliance
timeFrame: Outcome measures will be conducted within one year after completion.
measure: Monitoring of prognostic indices
timeFrame: Outcome measures will be conducted within one year after completion.
measure: Assessment of the extrapulmonary symptoms
timeFrame: Outcome measures will be conducted within one year after completion.
measure: Quality of life assessment(SGRQ)
timeFrame: Outcome measures will be conducted within one year after completion.
Locations:
city: Brno
country: Czechia
facility: University Hospital Brno
city: Ceské Budějovice
country: Czechia
facility: Hospital Ceske Budejovice
city: Hradec Kralove
country: Czechia
facility: University Hospital Hradec Kralove
city: Jihlava
country: Czechia
facility: Hospital Jihlava
city: Liberec
country: Czechia
facility: Regional Hospital Liberec
city: Mlada Boleslav
country: Czechia
facility: Regional hospital Mlada Boleslav
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
city: Plzen
country: Czechia
facility: EUC Klinika Plzen
city: Prague
country: Czechia
facility: Thomayer Hospital
city: Prague
country: Czechia
facility: University Hospital in Motol
city: Prague
country: Czechia
facility: Hospital Na Bulovce
city: Usti nad Labem
country: Czechia
facility: Masaryk Hospital in Usti nad Labem
city: Zlin
country: Czechia
facility: Tomas Bata Regional Hospital
Study officials:
affiliation: University Hospital Hradec Kralove
name: Vladimir Koblizek, Assoc. Prof. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.