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BREZTRI REGULATORY POST MARKETING SURVEILLANCE IN KOREA

Recruitingn/aAges any - anyAllAstraZeneca
NCT07570394 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

10 sites
Research Site
Chuncheon, South Korea
Research Site
Daegu, South Korea
Research Site
Goyang-si, South Korea
Research Site
Gwangmyeong, South Korea
Research Site
Jinju, South Korea
Research Site
Seongnam-si, South Korea
Research Site
Seongnam-si, South Korea
Research Site
Seoul, South Korea

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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