BREZTRI REGULATORY POST MARKETING SURVEILLANCE IN KOREA
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAstraZeneca
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Other off-label indications outside of the locally approved prescribing information
Pregnant and/or breast feeding
Current participation in any interventional trial
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Locations
Sponsors and collaborators
Source ClinicalTrials.gov