Clinical Trial

BREZTRI REGULATORY POST MARKETING SURVEILLANCE IN KOREA

Study acronym: Breztri rPMS
Not Yet Recruiting
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Summary
As part of a post-approval commitment requested by the Ministry of Food and Drug Safety (MFDS), this open-label, single-arm, multicentre, observational Post-Marketing Surveillance (PMS) study aims to characterize the safety profile of Breztri in real-world clinical practice settings, either confirming known safety outcomes or identifying previously unsuspected adverse drug reactions. The study will also evaluate effectiveness of Breztri in real-world clinical practice settings, generating essential clinical evidence from a broader and more diverse Korean patient population representative of daily medical practice.
Trial Details
NCT Number NCT07570394
Lead Sponsor AstraZeneca
Conditions Chronic Obstructive Pulmonary Disease (COPD)
Enrollment 600 participants
Start Date 2026-07-31
Primary Completion 2027-07-31 (estimated)
Study Completion 2027-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-06