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:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
NCT ID:
NCT02838108
Eligibility Criteria:
Inclusion Criteria:
* Subjects must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of data collection
* Subjects must be ≥40 years of age
* Subjects must have a greater than or equal to 10 pack-year history of tobacco exposure
* Subjects must have:
1. COPD confirmed by spirometry performed at screening (as demonstrated by FEV1/FVC \< 0.70) or
2. If the FEV1/FVC is ≥ 0.7, the subject must be a symptomatic current or past Smoker with Respiratory Symptoms (SRS) as defined by meeting the following spirometry and respiratory symptom criteria at screening: FVC ≥ 80% of predicted and CAT score ≥ 10 or
3. Preserved Ratio Impaired Spirometry (PRISm), defined as a reduced
FEV1 in the setting of a preserved FEV1/FVC ratio:
FEV1/FVC ≥ 0.7 AND FEV1 \< 80% of predicted
Exclusion Criteria:
* Participation in an investigational drug trial at the time of screening
* Subjects listed for lung transplantation at the time of screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT02838108
Study Brief:
Protocol Section:
NCT02838108