NCT07570394Recruiting
BREZTRI REGULATORY POST MARKETING SURVEILLANCE IN KOREA
Source: ClinicalTrials.gov · Last updated 23 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 600 (estimated)
- First submitted
- 30 Apr 2026
- Start date
- 17 Sept 2026
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- AstraZeneca
- NCT number
- NCT07570394
What you commit to
- Study type: Observational
- Planned participants: 600
- From 17 Sept 2026 to the primary completion date, 31 Jul 2027
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Other off-label indications outside of the locally approved prescribing information
- Pregnant and/or breast feeding
- Current participation in any interventional trial
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Research Site Coordinator of this site? Confirm its status | Chuncheon | South Korea | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Daegu | South Korea | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Goyang-si | South Korea | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Gwangmyeong | South Korea | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Jinju | South Korea | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Wŏnju | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.