Breztri real-world safety and effectiveness in Korean patients with COPD or asthma
Official title: BREZTRI REGULATORY POST MARKETING SURVEILLANCE IN KOREA
Run by AstraZeneca · NCT07570394 · Data updated 2026-11-12
This post-marketing study tests Breztri in real-world Korean patients with COPD or asthma to see how safe it is and how well it works when used as usual care.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 600 (estimated) |
| Sponsor | AstraZeneca Industry-sponsored |
| Locations | 10 sites (Chuncheon and 9 other locations) |
| Status | Recruiting |
| Started | September 17, 2026 |
| Main results expected | July 31, 2027 |
| Study ends | July 31, 2027 |
| Registry record updated | September 23, 2026 |
| Trial ID | NCT07570394 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults diagnosed with COPD or asthma who newly initiate Breztri per Korean labeling and provide informed consent.
✕Probably not a fit
Patients who do not respond to Breztri or who have contraindications or off-label use may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open-label, single-arm, multicenter observational study collects primary data on Breztri in routine clinical practice in Korea. It aims to characterize safety outcomes and assess real-world effectiveness over up to 24 weeks, enrolling at least 600 patients who start Breztri per approved labeling. Participation is based on physician practice patterns and informed consent, with around 30 study sites. Data will reflect how Breztri performs outside controlled trials, including any previously unrecognized adverse reactions. Concomitant medications may be used as clinically indicated, and follow-up schedules are determined by treating physicians.
Why it matters
Potential benefit: If successful, the study could provide real-world evidence of Breztri’s safety and effectiveness in Korean patients with COPD or asthma.
How similar studies have gone: Post-marketing surveillance in real-world settings has shown value in identifying safety signals and practical effectiveness in similar inhaled therapies.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Research Site
Daegu, South Korea Recruiting -
Research Site
Seongnam-si, South Korea Recruiting -
Research Site
Seoul, South Korea Recruiting -
Research Site
Wŏnju, South Korea Recruiting -
Research Site
Chuncheon, South Korea Not yet recruiting -
Research Site
Goyang-si, South Korea Not yet recruiting
Show 4 more locations
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Research Site
Gwangmyeong, South Korea Not yet recruiting -
Research Site
Jinju, South Korea Not yet recruiting -
Research Site
Seongnam-si, South Korea Not yet recruiting -
Research Site
Seoul, South Korea Not yet recruiting
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.