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 — DRUG
    This 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: Prompt
    Patients initiating BGF within 30-days of exacerbation
  • Arm: Delayed
    Patients initiating BGF within 31-180 days of exacerbation

Primary Outcome Measure

Annualized COPD Exacerbation Event Rate [ Time Frame: 180 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
AstraZenecaGaithersburgMaryland20878-

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