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 @ 3:24 PM
Ignite Modification Date:
2025-12-24 @ 3:24 PM
NCT ID:
NCT02040792
Eligibility Criteria:
Inclusion Criteria:
* Subject is a male or female subject 40 years of age or older
* Subject must have a negative pregnancy test, and must be prepared to use effective contraception if of child-bearing potential
* Subject is capable of performing reproducible spirometry maneuvers
* Subject has post-bronchodilator FEV1/FVC ratio \<0.7
* Subject has moderate-to-severe stable COPD (Stage 2 or 3 according to the GOLD Guidelines)
* Subject has a post-bronchodilator FEV1 greater than or equal to 30% and less than 80% of predicted normal
* Subject has a current or past smoking history of at least 10 pack-years.
Exclusion Criteria:
* Subject has a significant respiratory disease or disorder other than COPD that would affect the interpretation of data from this study
* Subject has a history of reactions or hypersensitivity to inhaled or nebulized anticholinergic or beta-agonist agents
* Subject suffers from any medical condition that would preclude the use of inhaled anticholinergic agents
* Subject has been hospitalized for COPD or pneumonia within 12 weeks
* Subject requires long-term oxygen therapy (\>15 hours a day)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT02040792
Study Brief:
Protocol Section:
NCT02040792