BREZTRI REGULATORY POST MARKETING SURVEILLANCE IN KOREA (Breztri rPMS)

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 Overview

• Status: Not yet recruiting
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Detailed Description

This is an open-label, 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 assess safety profile for patients receiving Breztri under the approved indication(s) in Korea.

The secondary objective of this study is to assess effectiveness for patients 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 effectiveness for patients receiving Breztri under the approved indication(s) in Korean patients.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients newly initiating treatment with Breztri in accordance with the local prescribing information will be enrolled.

Description

Inclusion Criteria:

1. Patients who have been diagnosed with COPD.
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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline to week 12 and 24 in pre-dose Forced Expiratory Volume in 1 second (FEV₁)	Effectiveness analyses will be performed for effectiveness analysis population, defined as patients among the safety population who (i) have completed 12 or 24 weeks of treatment with Breztri, and (ii) have available FEV₁ data both at baseline (within 30 days prior to the first dose of Breztri) and at a visit occurring within 6 weeks prior to or subsequent to the 12- or 24-week treatment timepoint. If multiple measurements are available within this time window, the value closest to the 12- and 24-week target will be used.	12 or 24 weeks
Change from baseline to week 12 and 24 in COPD Assessment Test (CAT) score	Effectiveness analyses will be performed for effectiveness analysis population, defined as patients among the safety population who (i) have completed 12 or 24 weeks of treatment with Breztri, and (ii) have available CAT score data both at baseline (within 30 days prior to the first dose of Breztri) and at a visit occurring within 6 weeks prior to or subsequent to the 12- or 24-week treatment timepoint. If multiple measurements are available within this time window, the value closest to the 12- and 24-week target will be used.	12 or 24 weeks

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Estimated): July 31, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: April 30, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: D5980R00025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at 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.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.

Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No