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.

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.

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

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

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.

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.

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.