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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01923051
Recruitment Status : Unknown
Verified June 2019 by Zuzana Zbožínková, M.Sc., Masaryk University.
Recruitment status was:  Active, not recruiting
First Posted : August 14, 2013
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Zuzana Zbožínková, M.Sc., Masaryk University

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.


Condition or disease
Chronic Obstructive Airway Disease

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

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Study Type : Observational
Actual Enrollment : 813 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : August 2013
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases




Primary Outcome Measures :
  1. Assessment of all-cause mortality [ Time Frame: Outcome 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 Outcome Measures :
  1. Assessment of morbidity [ Time Frame: Outcome 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 Outcome Measures:
  1. Monitoring of lung function decline [ Time Frame: Outcome 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.

  2. Monitoring of activity of daily living [ Time Frame: Outcome 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.

  3. Monitoring of COPD categories [ Time Frame: Outcome 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.

  4. Monitoring of therapeutic compliance [ Time Frame: Outcome 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).

  5. Monitoring of prognostic indices [ Time Frame: Outcome 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.

  6. Assessment of the extrapulmonary symptoms [ Time Frame: Outcome 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.

  7. Quality of life assessment(SGRQ) [ Time Frame: Outcome measures will be conducted within one year after completion. ]
    Regular (annual) evaluation of quality of life using SGRQ.


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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01923051


Locations
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Czechia
University Hospital Brno
Brno, Czechia, 625 00
Hospital Ceske Budejovice
Ceské Budějovice, Czechia
University Hospital Hradec Kralove
Hradec Kralove, Czechia, 500 05
Hospital Jihlava
Jihlava, Czechia, 586 33
Regional Hospital Liberec
Liberec, Czechia, 460 63
Regional hospital Mlada Boleslav
Mlada Boleslav, Czechia
University Hospital Olomouc
Olomouc, Czechia, 775 20
University Hospital Ostrava
Ostrava, Czechia, 708 52
EUC Klinika Plzen
Plzen, Czechia, 301 00
Thomayer Hospital
Prague, Czechia, 140 59
University Hospital in Motol
Prague, Czechia, 150 06
Hospital Na Bulovce
Prague, Czechia, 180 81
Masaryk Hospital in Usti nad Labem
Usti nad Labem, Czechia, 401 13
Tomas Bata Regional Hospital
Zlin, Czechia, 760 01
Sponsors and Collaborators
Zuzana Zbožínková, M.Sc.
Investigators
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Principal Investigator: Vladimir Koblizek, Assoc. Prof. PhD University Hospital Hradec Kralove
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zuzana Zbožínková, M.Sc., Zuzana Zbozinkova PharmDr, Masaryk University
ClinicalTrials.gov Identifier: NCT01923051    
Other Study ID Numbers: 1301100001
1301100001 ( Other Identifier: State Institute for Drug Control, Czech Republic )
First Posted: August 14, 2013    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Zuzana Zbožínková, M.Sc., Masaryk University:
chronic obstructive pulmonary disease
COPD
national database
observational
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Chronic Disease
Disease Attributes
Pathologic Processes