BREZTRI REGULATORY POST MARKETING SURVEILLANCE IN KOREA
Trial statusNot yet recruiting
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.
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
No trial groups listed
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
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.
Time frame
12 or 24 weeks2
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.
Time frame
12 or 24 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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