Chronic Obstructive Pulmonary Disease (COPD)Breztri rPMSNCT07570394
BREZTRI REGULATORY POST MARKETING SURVEILLANCE IN KOREA
An observational study of Chronic Obstructive Pulmonary Disease (COPD) and Asthma, run by AstraZeneca at 10 sites in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Asthma
- How many people
- 600 participants
- Where
- 10 sitesSouth Korea
- Study dates
- 17 Sep 2026to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients newly initiating treatment with Breztri in accordance with the local prescribing information will be enrolled.
Who may be able to join
- 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
Who cannot join
- Other off-label indications outside of the locally approved prescribing information
- Pregnant and/or breast feeding
- Current participation in any interventional trial
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
10 sites in 1 country
South Korea10 sites, 10 recruiting
- Not yet recruiting
Research Site
Chuncheon, 24289
- Recruiting
Research Site
Daegu, 41931
- Not yet recruiting
Research Site
Goyang-si, 10380
- Not yet recruiting
Research Site
Gwangmyeong, 14353
- Not yet recruiting
Research Site
Jinju, 52727
- Recruiting
Research Site
Seongnam-si, 13590
- Not yet recruiting
Research Site
Seongnam-si, 13620
- Recruiting
Research Site
Seoul, 4401
- Not yet recruiting
Research Site
Seoul, 6973
- Recruiting
Research Site
Wŏnju, 26426
About this study
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.
Read the detailed description
This is an open-label, primary data collection, single-arm, multicentre, observational study. Eligible patients who initiate treatment with Breztri according to approved indications will be enrolled after obtaining informed consent. All patients treated (minimum 600 patients required) with Breztri in accordance with the local prescribing information are eligible for enrolment in this study. Initiation or continuation of Breztri prescription and patient enrolment will depend on physicians' medical decisions as per routine clinical practice. Approximately 30 study sites are expected to participate in this study.
As this study will be performed under clinical practice, the investigator may prescribe any other concomitant medications that are necessary for the patient as locally approved.
The total number of visits and the visit time will be determined at the discretion of the investigator based on the patient's condition.
Patients will be observed for up to 24 weeks. Follow-up will begin on the date of the first administration of Breztri (index date). However, if a patient is found to meet any of the exclusion criteria after enrolment, no additional follow-up (including the 30-day safety follow-up) will be conducted.
The primary objective of this study is to characterize the safety profile separately in patients with COPD and in patients with asthma receiving Breztri under the approved indication(s) in Korea over a 24-week follow-up period, or until the end of treatment (EoT) if discontinued earlier.
The secondary objective of this study is to describe changes in clinical outcomes from baseline to week 12 and week 24, separately in patients with COPD and in patients with asthma receiving Breztri under the approved indication(s) in Korea.
The exploratory objective of this study is to identify patients' baseline characteristics that might be associated with safety and clinical outcomes separately in patients with COPD and in patients with asthma receiving Breztri under the approved indication(s) in Korean patients.
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic obstructive pulmonary disease | Patients who have been diagnosed with COPD | |
| Asthma | Patients who have been diagnosed with asthma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence proportion of Adverse Events (AEs)/Adverse Drug Reactions (ADRs)
All AEs/ADRs will be presented as the number of patients with an outcome of interest, the incidence proportion percentages, and the number of events, the corresponding Clopper-Pearson's two-sided 95% exact confidence interval (CI), and the number of events.
Measured: 24 weeks
Incidence proportion of Serious AEs (SAEs)/Serious ADRs (SADRs)
SAEs/SADRs will be presented as the number of patients with an outcome of interest, the incidence proportion percentages, and the number of events, the corresponding Clopper-Pearson's two-sided 95% exact confidence interval (CI), and the number of events.
Measured: 24 weeks
Incidence proportion of Unexpected AEs/Unexpected ADRs
Unexpected AEs/ADRs will be presented as the number of patients with an outcome of interest, the incidence proportion percentages, and the number of events, the corresponding Clopper-Pearson's two-sided 95% exact confidence interval (CI), and the number of events.
Measured: 24 weeks
Incidence proportion of Unexpected SAEs/Unexpected SADRs
Unexpected SAEs/SADRs, will be presented as the number of patients with an outcome of interest, the incidence proportion percentages, and the number of events, the corresponding Clopper-Pearson's two-sided 95% exact confidence interval (CI), and the number of events.
Measured: 24 weeks
Secondary outcomes (3)
Describe changes in clinical outcomes from baseline to week 12 and 24 in patients with COPD receiving Breztri under the approved indication(s) in Korea
Change from baseline to week 12 and 24(within a window of ±6 weeks) in predose Forced Expiratory Volume in 1 second (FEV₁) FEV₁ represents the volume of air forcibly exhaled in the first second of a forced expiratory maneuver, measured in milliliters (mL). Improvement indicates enhanced lung function.
Measured: 12 and 24 weeks
Change from baseline to week 12 and 24 in COPD Assessment Test (CAT) score
Change from baseline to week 12 and 24(within a window of ±6 weeks) in COPD Assessment Test (CAT) score The CAT is an 8-item questionnaire assessing the impact of COPD symptoms on health status. Scores range from 0 (best) to 40 (worst), with lower scores indicating better health status.
Measured: 12 and 24 weeks
Describe changes in clinical outcomes from baseline to week 12 and 24 in patient with asthma receiving Breztri under the approved indication(s) in Korea
Change from baseline to week 12 and 24(within a window of ±4 weeks) in investigator assessed asthma control
Asthma control assessed by the study investigator according to GINA guidelines:
"Well controlled", "Partly controlled", and "Uncontrolled".
Measured: 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start17 Sep 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570394
- Sponsor's protocol ID
- D5980R00025
- Acronym
- Breztri rPMS
- Status last verified
- Sep 2026
- First submitted
- 30 Apr 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BREZTRI REGULATORY POST MARKETING SURVEILLANCE IN KOREA
- ClinicalTrials.gov ID
- NCT07570394
- Acronym / sponsor ID
- Breztri rPMS / D5980R00025
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open-label, primary data collection, single-arm, multicentre, observational study. Eligible patients who initiate treatment with Breztri according to approved indications will be enrolled after obtaining informed consent. All patients treated (minimum 600 patients required) with Breztri in accordance with the local prescribing information are eligible for enrolment in this study. Initiation or continuation of Breztri prescription and patient enrolment will depend on physicians' medical decisions as per routine clinical practice. Approximately 30 study sites are expected to participate in this study.
As this study will be performed under clinical practice, the investigator may prescribe any other concomitant medications that are necessary for the patient as locally approved.
The total number of visits and the visit time will be determined at the discretion of the investigator based on the patient's condition.
Patients will be observed for up to 24 weeks. Follow-up will begin on the date of the first administration of Breztri (index date). However, if a patient is found to meet any of the exclusion criteria after enrolment, no additional follow-up (including the 30-day safety follow-up) will be conducted.
The primary objective of this study is to characterize the safety profile separately in patients with COPD and in patients with asthma receiving Breztri under the approved indication(s) in Korea over a 24-week follow-up period, or until the end of treatment (EoT) if discontinued earlier.
The secondary objective of this study is to describe changes in clinical outcomes from baseline to week 12 and week 24, separately in patients with COPD and in patients with asthma receiving Breztri under the approved indication(s) in Korea.
The exploratory objective of this study is to identify patients' baseline characteristics that might be associated with safety and clinical outcomes separately in patients with COPD and in patients with asthma receiving Breztri under the approved indication(s) in Korean patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic obstructive pulmonary disease | – | –Patients who have been diagnosed with COPD |
| Asthma | – | –Patients who have been diagnosed with asthma |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients newly initiating treatment with Breztri in accordance with the local prescribing information will be enrolled.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Other off-label indications outside of the locally approved prescribing information
- Pregnant and/or breast feeding
- Current participation in any interventional trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence proportion of Adverse Events (AEs)/Adverse Drug Reactions (ADRs)
Time frame: 24 weeks
All AEs/ADRs will be presented as the number of patients with an outcome of interest, the incidence proportion percentages, and the number of events, the corresponding Clopper-Pearson's two-sided 95% exact confidence interval (CI), and the number of events.
Incidence proportion of Serious AEs (SAEs)/Serious ADRs (SADRs)
Time frame: 24 weeks
SAEs/SADRs will be presented as the number of patients with an outcome of interest, the incidence proportion percentages, and the number of events, the corresponding Clopper-Pearson's two-sided 95% exact confidence interval (CI), and the number of events.
Incidence proportion of Unexpected AEs/Unexpected ADRs
Time frame: 24 weeks
Unexpected AEs/ADRs will be presented as the number of patients with an outcome of interest, the incidence proportion percentages, and the number of events, the corresponding Clopper-Pearson's two-sided 95% exact confidence interval (CI), and the number of events.
Incidence proportion of Unexpected SAEs/Unexpected SADRs
Time frame: 24 weeks
Unexpected SAEs/SADRs, will be presented as the number of patients with an outcome of interest, the incidence proportion percentages, and the number of events, the corresponding Clopper-Pearson's two-sided 95% exact confidence interval (CI), and the number of events.
3 secondary outcomes
Describe changes in clinical outcomes from baseline to week 12 and 24 in patients with COPD receiving Breztri under the approved indication(s) in Korea
Time frame: 12 and 24 weeks
Change from baseline to week 12 and 24 in COPD Assessment Test (CAT) score
Time frame: 12 and 24 weeks
Describe changes in clinical outcomes from baseline to week 12 and 24 in patient with asthma receiving Breztri under the approved indication(s) in Korea
Time frame: 12 and 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD) and Asthma, run by AstraZeneca at 10 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence proportion of Adverse Events (AEs)/Adverse Drug Reactions (ADRs) (time frame: 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.