BREZTRI REGULATORY POST MARKETING SURVEILLANCE IN KOREA

NCT07570394 | Not Yet Recruiting

• 1 other identifier: D5980R00025
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Change from baseline to week 12 and 24 in pre-dose Forced Expiratory Volume in 1 second (FEV₁)

  12 or 24 weeks

• Change from baseline to week 12 and 24 in COPD Assessment Test (CAT) score

  12 or 24 weeks

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients who have been diagnosed with COPD.
• 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

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): July 31, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.