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 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT04606394
Eligibility Criteria:
Inclusion Criteria:
* smoking history \>10 pack years
* pre-bronchodilator FEV1 \<60% predicted
* post-bronchodilator FEV1/FVC \<70%
* female participants are eligible to participate if they are not pregnant, not breastfeeding, and at least one of the following conditions applies:
* not a woman of childbearing potential OR
* agree to follow the contraceptive guidance during the treatment period and until the safety follow-up contact after the last dose of study treatment
* stratification requiring at least 1/3 of patients having a PIF of \< 60L/min (AM pre-dose based on using the level 2 InCheck Dial resistance setting with a sharp maximal effort starting after exhaling fully)
Exclusion Criteria:
* any subject with unstable disease, including
* COPD exacerbation in the last 6 weeks
* upper respiratory tract in in the last 4 weeks
* COPD or upper respiratory tract infection during run-in (subjects may be re-screened x 1 when stable after an acute event)
* pulmonary disease other than COPD
* any lung resection
* unstable cardiac conditions (at the discretion of the investigator)
* other unstable medical conditions (at the discretion of the investigator)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT04606394
Study Brief:
Protocol Section:
NCT04606394