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 @ 3:55 PM
Ignite Modification Date:
2025-12-24 @ 3:55 PM
NCT ID:
NCT02097992
Eligibility Criteria:
Inclusion Criteria:
* Twenty-four patients with physician-diagnosed COPD (female and male, current smokers or ex-smokers) over the age of 45 years will be recruited for this study.
* The patients will have to have a smoking history of at least 10 pack-years, and they must have been using an ICS regularly for at least 4 weeks at the time of screening.
* Confirmation of the diagnosis of COPD will require the presence of persistent exertional dyspnea and a post-bronchodilator FEV1 of less than 80% of predicted and FEV1/FVC ratio less than 0.7 (GOLD stage ≥2). At entry into the study, the patients will have to be clinically stable; they will be allowed to remain on their regular COPD treatment regimen and use a LABA and/or LAMA until 24 hours before, and a SABA and/or short-acting muscarinic antagonist (SAMA) until 6 hours before coming to the laboratory. If using roflumilast, the subjects will have to discontinue it 4 weeks before entering into the study.-
Exclusion Criteria:
* Women of childbearing potential who do not use accepted birth control measures
* Pregnant and breast-feeding women.
* Use of cardiovascular medications that cannot be held on the study days
* Use of oral airway medications or anti-inflammatory agents
* Use of supplemental oxygen that cannot be discontinued during the laboratory visit
* Subjects with known SABA or roflumilast intolerance
* An acute COPD exacerbation within four weeks prior to the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT02097992
Study Brief:
Protocol Section:
NCT02097992