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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07414134
Eligibility Criteria:
Inclusion Criteria:
* ≥ 1 prescription(s) fill for BGF on or following January 1, 2021
* Patients must have evidence of a severe qualifying exacerbation event.
* The qualifying severe exacerbation event discharge date must occur within the 180-day period preceding the initiation of BGF for classification of patients into prompt or delayed initiators of BGF.
* The discharge date of the first (earliest) observed qualifying index exacerbation event will be set as the index date
* ≥ 12 months of continuous health plan enrollment preceding the qualifying index exacerbation event date (baseline period)
* ≥ 1 day of continuous enrollment following the qualifying index exacerbation date
* Age ≥ 40 years on the qualifying index exacerbation date
Exclusion Criteria:
* Presence of cancer diagnoses other than basal or squamous cell skin cancer during the baseline period preceding the index date or entire follow-up period
* Presence of ≥2 claims with a diagnosis of interstitial fibrosis or sarcoidosis diagnoses during the period preceding the index date or entire follow-up period
* Presence of SITT at any time during the entire available history of patients' data preceding the index date through BGF initiation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT07414134
Study Brief:
Protocol Section:
NCT07414134