Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT02119494
Eligibility Criteria:
Inclusion Criteria:
1. Age \> 40 years
2. Clinical diagnosis of COPD with post-bronchodilator FEV1/FVC \< 0.7
3. Smoking burden ≥ 10 pack-years in smokers (group A). Evidence of exposure to at least one other typical inhaled COPD risk factor: environmental tobacco smoke, professional exposures, etc. (group B) Each country will include 300 COPD subjects with positive history of smoking (at least 10 pack-years). Consecutive non-smokers with COPD can be enrolled above this limit. Institute for Biostatistics and Analyses, Masaryk University, Brno, The Czech Republic will analyze both COPD groups (A and B) separately
4. Stable disease for at least 4 weeks
5. Outpatient status
6. Informed Consent
Exclusion Criteria:
1. Exacerbation of COPD and/or instable co-morbid condition
2. Patient during hospital stay for whatever reason (lung or co-morbidities)
3. Patient is not able and willing to participate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT02119494
Study Brief:
Protocol Section:
NCT02119494