Exacerbations and Real-World Outcomes Among Patients With Chronic Obstructive Pulmonary Disease F… (NCT07414134) | Clinical Trial Compass
CompletedNot Applicable
Exacerbations and Real-World Outcomes Among Patients With Chronic Obstructive Pulmonary Disease Following Severe Exacerbation
United States3,598 participantsStarted 2025-10-31
Plain-language summary
This real-world retrospective study will use de-identified administrative claims data and will examine patients with a diagnosis of COPD who have experienced a qualifying severe disease exacerbation and received subsequent treatment with BGF. Agreed COPD patient data from the Inovalon MORE2 Registry® and Centers for Medicare \& Medicaid Services (CMS) 100% Medicare Fee for Service (FFS) database spanning from January 1, 2021 to the most recently available data (September 30th, 2024 for the MORE2 database, and December 31st, 2023 for the Medicare FFS database) will be used for this analysis. All patients will be required to present at least one prescription claim for BGF. Patients will also be required to show evidence of a qualifying severe COPD exacerbation event during the 180-day period preceding initiation of BGF. Index date will be set as the date of discharge from the qualifying severe exacerbation event.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.