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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT01322594
Eligibility Criteria:
Inclusion Criteria:
* Aged ≥ 40 years at time of screening.
* Females of non-childbearing potential defined as surgically sterile or at least 2 years postmenopausal.
* Males, unless surgically sterile, must use 2 highly effective methods of birth control from screening through end of trial.
* A diagnosis of mild to moderate COPD.
* Cigarette smoking history of ≥10 pack years.
* Ability to understand and comply with protocol requirements, instructions and restrictions.
* COPD symptoms adequately controlled on a therapeutic regimen that has not changed in the 4 weeks prior to screening.
Exclusion Criteria:
* Current diagnosis of any respiratory condition other than COPD.
* Active or history of any disease or condition that would, in the opinion of the investigator and/or medical monitor, place the subject at an unacceptable risk to participate in this study.
* History of or suspected history of alcohol misuse or recreational substance abuse.
* Treatment with oral or IV corticosteroids within 8 weeks prior to screening.
* Concurrent enrolment in another clinical study.
* Receipt of any investigational drug therapy of use of any biologicals within 6 months prior to screening.
* Known history of allergy or reaction to any component of the investigational product.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT01322594
Study Brief:
Protocol Section:
NCT01322594