BREZTRI REGULATORY POST MARKETING SURVEILLANCE IN KOREA
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Obstructive Pulmonary Disease (COPD). Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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, 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.
Primary outcome measures
- Incidence proportion of Adverse Events (AEs)/Adverse Drug Reactions (ADRs) [Time frame: 24 weeks]
- Incidence proportion of Serious AEs (SAEs)/Serious ADRs (SADRs) [Time frame: 24 weeks]
- Incidence proportion of Unexpected AEs/Unexpected ADRs [Time frame: 24 weeks]
- Incidence proportion of Unexpected SAEs/Unexpected SADRs [Time frame: 24 weeks]
Secondary outcome measures (2)
- Change from baseline to week 12 and 24 in pre-dose Forced Expiratory Volume in 1 second (FEV₁) [Time frame: 12 or 24 weeks]
- Change from baseline to week 12 and 24 in COPD Assessment Test (CAT) score [Time frame: 12 or 24 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Other off-label indications outside of the locally approved prescribing information
- Pregnant and/or breast feeding
- Current participation in any interventional trial
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07570394 · D5980R00025