BREZTRI REGULATORY POST MARKETING SURVEILLANCE IN KOREA

Conditions studied

Chronic Obstructive Pulmonary Disease (COPD), Asthma

About this study

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.

Primary outcomes

• Incidence proportion of Adverse Events (AEs)/Adverse Drug Reactions (ADRs) (24 weeks)
• Incidence proportion of Serious AEs (SAEs)/Serious ADRs (SADRs) (24 weeks)
• Incidence proportion of Unexpected AEs/Unexpected ADRs (24 weeks)
• Incidence proportion of Unexpected SAEs/Unexpected SADRs (24 weeks)