BREZTRI REGULATORY POST MARKETING SURVEILLANCE IN KOREA

Starting soon

Conditions studied: Chronic Obstructive Pulmonary Disease (COPD)

In brief

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.

Key facts

Study ID

NCT07570394

Run by

AstraZeneca

People needed

600

Starts

2026-07-31

Expected to finish

2027-07-31

Last updated by the study team

2026-05-06

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who have been diagnosed with COPD.
• Patients who have newly initiated treatment with Breztri according to the approved label in Korea
• Provision of signed and dated written informed consent by the patient or legally acceptable representative

You may not qualify if…

• Other off-label indications outside of the locally approved prescribing information
• Pregnant and/or breast feeding
• Current participation in any interventional trial

Full record on ClinicalTrials.gov

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