NCT07414134

Exacerbations and Real-World Outcomes Among Patients With Chronic Obstructive Pulmonary Disease Following Severe Exacerbation

Exacerbations and Real-World Outcomes Among Patients With Chronic Obstructive Pulmonary Disease Following Severe Exacerbation (MITOS:EROS+DISCHARGE)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,598 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	BGF- BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL	This is a real-world observational study evaluating the timing of BGF, post discharge.

Timeline

• Start date: 2025-10-31
• Primary completion: 2025-11-28
• Completion: 2025-11-28
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States