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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Masaryk University
Sponsor:
Information provided by (Responsible Party):
Karel Hejduk, Masaryk University
ClinicalTrials.gov Identifier:
NCT01923051
First received: August 7, 2013
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

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.


Condition
Chronic Obstructive Airway Disease

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Masaryk University:

Primary Outcome Measures:
  • Assessment of all-cause mortality [ Time Frame: Outcome measures will be conducted within one year after completion. ] [ Designated as safety issue: No ]
    Assessment of all-cause mortality in an unselected group of consecutive patients with severe COPD (post-bronchodilator FEV1 ≤ 60%).


Secondary Outcome Measures:
  • Assessment of morbidity [ Time Frame: Outcome measures will be conducted within one year after completion. ] [ Designated as safety issue: No ]
    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:
  • Monitoring of lung function decline [ Time Frame: Outcome measures will be conducted within one year after completion. ] [ Designated as safety issue: No ]
    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.

  • Monitoring of activity of daily living [ Time Frame: Outcome measures will be conducted within one year after completion. ] [ Designated as safety issue: No ]
    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.

  • Monitoring of COPD categories [ Time Frame: Outcome measures will be conducted within one year after completion. ] [ Designated as safety issue: No ]
    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.

  • Monitoring of therapeutic compliance [ Time Frame: Outcome measures will be conducted within one year after completion. ] [ Designated as safety issue: No ]
    Regular (once a year) monitoring of inhalation technique and evaluation of Morisky Medication Adherence Scale 4 (MMAS-4).

  • Monitoring of prognostic indices [ Time Frame: Outcome measures will be conducted within one year after completion. ] [ Designated as safety issue: No ]
    Annual monitoring of several prognostic indices (Celli´s BODE, Puhan´s BODE, ADO) and analysis of the differences in patients with specific COPD phenotypes.

  • Assessment of the extrapulmonary symptoms [ Time Frame: Outcome measures will be conducted within one year after completion. ] [ Designated as safety issue: No ]
    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.

  • Quality of life assessment(SGRQ) [ Time Frame: Outcome measures will be conducted within one year after completion. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1000
Study Start Date: August 2013
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
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
  • Analysis of extra-pulmonary impairment during
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01923051

Contacts
Contact: Karel Hejduk, MSc +420 549 497 246 hejduk@iba.muni.cz

Locations
Czech Republic
University Hospital Brno Recruiting
Brno, Czech Republic, 625 00
Contact: Marek Plutinsky, MD         
University Hospital Hradec Kralove Recruiting
Hradec Kralove, Czech Republic, 500 05
Contact: Vladimir Koblizek, MD, PhD         
Hospital Jihlava Recruiting
Jihlava, Czech Republic, 586 33
Contact: Tomas Snizek, MD         
Regional Hospital Liberec Recruiting
Liberec, Czech Republic, 460 63
Contact: Tomas Vencalek, MD         
University Hospital Olomouc Recruiting
Olomouc, Czech Republic, 775 20
Contact: Jaromir Zatloukal, MD, PhD         
University Hospital Ostrava Recruiting
Ostrava, Czech Republic, 708 52
Contact: Patricie Popelkova, MD         
University Hospital Plzen Recruiting
Plzen, Czech Republic, 305 99
Contact: Petr Safranek, MD         
University Hospital in Motol Recruiting
Prague, Czech Republic, 150 06
Contact: Miroslav Marel, MD, PhD         
Thomayer Hospital Recruiting
Prague, Czech Republic, 140 59
Contact: Lucie Heribanova, MD         
Hospital Na Bulovce Recruiting
Prague, Czech Republic, 180 81
Contact: Norbert Pauk, MD, Ph.D         
Contact: Tomáš Dvořák, MD         
Masaryk Hospital in Usti nad Labem Recruiting
Usti nad Labem, Czech Republic, 401 13
Contact: Blanka Snelerova, MD         
Tomas Bata Regional Hospital Recruiting
Zlin, Czech Republic, 760 01
Contact: Marie Majercakova, MD         
Sponsors and Collaborators
Karel Hejduk
Investigators
Principal Investigator: Vladimir Koblizek, PhD University Hospital Hradec Kralove
  More Information

Additional Information:
No publications provided

Responsible Party: Karel Hejduk, Karel Hejduk, MSc, Masaryk University
ClinicalTrials.gov Identifier: NCT01923051     History of Changes
Other Study ID Numbers: 1301100001, 1301100001
Study First Received: August 7, 2013
Last Updated: April 24, 2014
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by Masaryk University:
chronic obstructive pulmonary disease
COPD
national database
observational

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 31, 2014