BREZTRI REGULATORY POST MARKETING SURVEILLANCE IN KOREA
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAstraZeneca
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Other off-label indications outside of the locally approved prescribing information
Pregnant and/or breast feeding
Current participation in any interventional trial
Trial population
Patients newly initiating treatment with Breztri in accordance with the local prescribing information will be enrolled.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
600 Participants
are grouped into 2 trial groupsGroup A: Chronic obstructive pulmonary disease
Group B: Asthma
Trial outcomes
Primary outcomes
1
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.
Time frame
24 weeks2
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.
Time frame
24 weeks3
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.
Time frame
24 weeks4
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.
Time frame
24 weeksSecondary outcomes
1
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.
Time frame
12 and 24 weeks2
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.
Time frame
12 and 24 weeks3
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".
Time frame
12 and 24 weeksSponsors and contacts
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Source ClinicalTrials.gov