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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
Diseases
Asthma, COPD
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

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Research Site
Coordinator of this site? Confirm its status
ChuncheonSouth KoreaNot yet recruiting
Research Site
Coordinator of this site? Confirm its status
DaeguSouth KoreaRecruiting
Research Site
Coordinator of this site? Confirm its status
Goyang-siSouth KoreaNot yet recruiting
Research Site
Coordinator of this site? Confirm its status
GwangmyeongSouth KoreaNot yet recruiting
Research Site
Coordinator of this site? Confirm its status
JinjuSouth KoreaNot yet recruiting
Research Site
Coordinator of this site? Confirm its status
Seongnam-siSouth KoreaRecruiting
Research Site
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Research Site
Coordinator of this site? Confirm its status
WŏnjuSouth KoreaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.