Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:24 AM
Study NCT ID:
NCT07414134
Status:
COMPLETED
Last Update Posted:
2026-02-17
First Post:
2025-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exacerbations and Real-World Outcomes Among Patients With Chronic Obstructive Pulmonary Disease Following Severe Exacerbation
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
Exacerbations and Real-World Outcomes Among Patients With Chronic Obstructive Pulmonary Disease Following Severe Exacerbation (MITOS:EROS+DISCHARGE)
Status:
COMPLETED
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: