Chronic Obstructive Airway DiseaseNCT01923051
Czech Multicentre Research Database of Chronic Obstructive Pulmonary Disease (COPD)
An observational study of Chronic Obstructive Airway Disease, run by Zuzana Zbožínková, M.Sc. at 14 sites in Czechia.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Airway Disease
- How many people
- 813 participants
- Where
- 14 sitesCzechia
- Study dates
- Aug 2013to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- "Pure" bronchial asthma without COPD
- "Pure" bronchiectasis without COPD
- Cystic fibrosis
- End-stage of COPD
- Non-curable malignancy
- Total non-compliance
- Immobility
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Czechia14 sites
University Hospital Brno
Brno, 625 00
Hospital Ceske Budejovice
Ceské Budějovice
University Hospital Hradec Kralove
Hradec Králové, 500 05
Hospital Jihlava
Jihlava, 586 33
Regional Hospital Liberec
Liberec, 460 63
Regional hospital Mlada Boleslav
Mladá Boleslav
University Hospital Olomouc
Olomouc, 775 20
University Hospital Ostrava
Ostrava, 708 52
EUC Klinika Plzen
Pilsen, 301 00
Thomayer Hospital
Prague, 140 59
University Hospital in Motol
Prague, 150 06
Hospital Na Bulovce
Prague, 180 81
Masaryk Hospital in Usti nad Labem
Ústí nad Labem, 401 13
Tomas Bata Regional Hospital
Zlín, 760 01
About this study
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)
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.
Read more
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.
Read the 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
- Keywords
- chronic obstructive pulmonary disease, COPD, national database, observational
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of all-cause mortality
Assessment of all-cause mortality in an unselected group of consecutive patients with severe COPD (post-bronchodilator FEV1 ≤ 60%).
Measured: Outcome measures will be conducted within one year after completion.
Secondary outcomes (1)
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%).
Measured: Outcome measures will be conducted within one year after completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Airway DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 813 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zuzana Zbožínková, M.Sc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zuzana Zbožínková, M.Sc., Masaryk University
- Investigators
- Vladimir Koblizek, Assoc. Prof. PhD, Principal investigator, University Hospital Hradec Kralove
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923051
- Sponsor's protocol ID
- 1301100001
- Other IDs
- 1301100001
- Status last verified
- Jun 2019
- First submitted
- 7 Aug 2013
- Last updated
- 13 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25419124Kulirova M, Solar M, Kopecky M, Novotna B, Plutinsky M, Brat K, Fila L, Vanik P, Musilova P, Dvorak T, Safranek P, Svoboda M, Koblizek V. A normal electrocardiogram indicates a better prognosis in patients with moderate to very severe chronic obstructive pulmonary disease. Sci Rep. 2025 Feb 5;15(1):4427. doi: 10.1038/s41598-025-89013-0.
PubMed 39910197Brat 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.
PubMed 32955038
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01923051
- Acronym / sponsor ID
- 1301100001
- Conditions
- Chronic Obstructive Airway Disease
- Keywords
- chronic obstructive pulmonary disease, COPD, national database, observational
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 813 participants (actual)
- Lead sponsor
- Zuzana Zbožínková, M.Sc.University, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 14 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- "Pure" bronchial asthma without COPD
- "Pure" bronchiectasis without COPD
- Cystic fibrosis
- End-stage of COPD
- Non-curable malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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%).
1 secondary outcome
Assessment of morbidity
Time frame: Outcome measures will be conducted within one year after completion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
- Results publication: PubMed 25419124Novotna 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.
- Derived from this study: PubMed 39910197Kulirova M, Solar M, Kopecky M, Novotna B, Plutinsky M, Brat K, Fila L, Vanik P, Musilova P, Dvorak T, Safranek P, Svoboda M, Koblizek V. A normal electrocardiogram indicates a better prognosis in patients with moderate to very severe chronic obstructive pulmonary disease. Sci Rep. 2025 Feb 5;15(1):4427. doi: 10.1038/s41598-025-89013-0.
- Derived from this study: PubMed 32955038Brat 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.
- Czech National Research Database of COPDLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Obstructive Airway Disease
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
RecruitingPhase 2
Oral Sildenafil for Exercise Capacity, Dyspnea and Cardiopulmonary Function in COPD
Chronic Obstructive Pulmonary Disease
Recruiting
Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD
COPD, Chronic Obstructive Pulmonary Disease
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Active, not recruitingPhase 2
Inhaled Treprostinil for Dyspnea and Exercise Intolerance in Mild COPD
COPD (Chronic Obstructive Pulmonary Disease)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir Koblizek, Assoc. Prof. PhD principal investigator
University Hospital Hradec Kralove
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Airway Disease, run by Zuzana Zbožínková, M.Sc. at 14 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of all-cause mortality (time frame: Outcome measures will be conducted within one year after completion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01923051, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2019.