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NCT07570394From ClinicalTrials.govRecruiting

BREZTRI REGULATORY POST MARKETING SURVEILLANCE IN KOREA

  • Chronic Obstructive Pulmonary Disease (COPD)
  • Asthma

At a glance

Phase
Phase not stated
Study type
Observational
Sponsor
AstraZeneca
Enrolment target
600
Started
17 September 2026
Main results due
31 July 2027
Study sites
10
Registry updated
23 September 2026

Can you take part?

  • No age limit is stated.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

1. Patients who have been diagnosed with COPD or asthma.
2. Patients who have newly initiated treatment with Breztri according to the approved label in Korea
3. Provision of signed and dated written informed consent by the patient or legally acceptable representative

Exclusion Criteria:

1. Other off-label indications outside of the locally approved prescribing information
2. Pregnant and/or breast feeding
3. Current participation in any interventional trial

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(10)

  • Research Site

    Chuncheon, South Korea

    Not yet recruiting

  • Research Site

    Daegu, South Korea

    Recruiting

  • Research Site

    Goyang-si, South Korea

    Not yet recruiting

  • Research Site

    Gwangmyeong, South Korea

    Not yet recruiting

  • Research Site

    Jinju, South Korea

    Not yet recruiting

  • Research Site

    Seongnam-si, South Korea

    Recruiting

  • Research Site

    Seongnam-si, South Korea

    Not yet recruiting

  • Research Site

    Seoul, South Korea

    Recruiting

  • Research Site

    Seoul, South Korea

    Not yet recruiting

  • Research Site

    Wŏnju, South Korea

    Recruiting

Showing 10 of 10 sites. 4 of the 10 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07570394. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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BREZTRI REGULATORY POST MARKETING SURVEILLANCE IN KOREA | Trialion