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:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-24 @ 2:35 PM
NCT ID:
NCT02058459
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of COPD with 30% ≤ FEV1 \< 60% and FEV1/FVC \<70% (post-bronchodilator);
* Patient ≥ 40 and ≤ 75 years of age at the time of consent;
* The patient has no child bearing potential or a negative pregnancy test (serum or urine), if applicable;
* Smoking history of at least 10 pack years;
* Non-smoking for a minimum of 2 months prior to consent and agrees to continue not smoking for the duration of the study;
* Participated in a pulmonary rehabilitation program or engaged in regular physical activity under professional supervision in the past 12 months;
Exclusion Criteria:
* Has been less than 6 weeks following the resolution of a COPD exacerbation or active lower respiratory infection (eg. pneumonia);
* History of recurrent respiratory infections and/or COPD exacerbations (more than 2 hospitalizations within 1 year of enrollment);
* Prior lung or chest procedure (eg. lung transplant, LVRS, BLVR, lung implant, metal stent, valves, coils, median sternotomy, bullectomy, segmentectomy, or lobectomy);
* Documented history of asthma diagnosed with onset \<30 years of age, cystic fibrosis, paradoxical vocal cord motion, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, severe interstitial lung disease or active tuberculosis;
* Pulmonary nodule requiring follow-up or intervention unless proven benign;
* Daily use of \>10 mg of prednisone or its equivalent at the time of enrollment;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT02058459
Study Brief:
Protocol Section:
NCT02058459