Safety and real-world use of Breztri in Korean people with COPD or asthma
Observes the safety and effects of Breztri in people with COPD or asthma.
Plain-language title generated from the registry record
Registry title: BREZTRI REGULATORY POST MARKETING SURVEILLANCE IN KOREA
Key facts
- Where
- Chuncheon, Daegu, Goyang-si, Gwangmyeong, Jinju, Seongnam-si, Seoul, and Wŏnju, South KoreaSee the 8 sites
Where in South Korea
- ChuncheonChuncheon, South KoreaNot yet recruiting
- DaeguDaegu, South KoreaTaking people
- Goyang-siGoyang-si, South KoreaNot yet recruiting
- GwangmyeongGwangmyeong, South KoreaNot yet recruiting
- JinjuJinju, South KoreaNot yet recruiting
- Seongnam-siSeongnam-si, South KoreaTaking people
- SeoulSeoul, South KoreaTaking people
- WŏnjuWŏnju, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT07570394
- Record updated
- 23 September 2026
- Original description
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.Read full original descriptionShow less
BREZTRI REGULATORY POST MARKETING SURVEILLANCE IN KOREA
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.
Inclusion: Patients who have been diagnosed with COPD or asthma; 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.
Exclusion: Other off-label indications outside of the locally approved prescribing information; Pregnant and/or breast feeding; Current participation in any interventional trial.