Prospective cohort study of COPD patients from Maastricht area: the Maastricht COPD Cohort (MCC)

Withdrawn

Conditions: chronic bronchitis
emphysema
10038716

Registration Number: NL-OMON38812

Lead Sponsor: CIRO+, expertisecentrum voor chronisch orgaanfalen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

- Adults, either sex, older than 40 years of age;
- Smoking history of 10 Pack Years or more;
- Diagnosis of COPD stages I-IV as defined by the Global initiative for chronic Obstructive Lung Disease (GOLD);
- Classified by COPD severity in group B or D, based on the GOLD criteria of COPD severity (Figure 1);
- Patients must be able to complete diaries and quality of life questionnaires;
- Patients must sign and date an informed consent prior to inclusion in the MCC.

Exclusion Criteria

- Progressively fatal disease, or life expectancy *6 months;
- Women who are breast feeding or are pregnant;
- Patients with mental conditions rendering them unable to understand the nature, scope, and possible consequences of the study;
- Patients unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study;
- Patients participating in an intervention study.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- The role of respiratory infections as pathogenic component of COPD<br /><br>exacerbations;<br /><br>- The individual response to respiratory pathogens associated with COPD<br /><br>exacerbations;<br /><br>- Determination and validation of the COPD phenotypes;<br /><br>- The natural history of systemic manifestations and co-morbidities of COPD and<br /><br>their interrelationships, associated to exacerbations;<br /><br>- The long-term effects of pulmonary rehabilitation;<br /><br>- The impact of exacerbations during pre-rehabilitation and post-rehabilitation<br /><br>on health outcomes;<br /><br>- Short- and long-term mortality.</p><br>

Secondary Outcome Measures