Exacerbations and Real-World Outcomes Among Patients With Chronic Obstructive Pulmonary Disease Following Severe Exacerbation
Part of paid clinical trials in Gaithersburg, Maryland.
- Sponsor
- AstraZeneca
- Study ID
- NCT07414134
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 40 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- BGF- BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL — DRUGThis is a real-world observational study evaluating the timing of BGF, post discharge.
Study Details
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.
Key Dates
- Start date
- Oct 31, 2025
- Status verified
- Feb 2026
- Primary completion
- Nov 28, 2025
- Completion
- Nov 28, 2025
Study Design
- Enrollment
- 3,598 participants (actual)
Arms
- Arm: PromptPatients initiating BGF within 30-days of exacerbation
- Arm: DelayedPatients initiating BGF within 31-180 days of exacerbation
Primary Outcome Measure
Annualized COPD Exacerbation Event Rate [ Time Frame: 180 days ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| AstraZeneca | Gaithersburg | Maryland | 20878 | - |
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