Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Conditions
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.
Detailed description
This is an open-label, primary data collection, 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 characterize the safety profile separately in patients with COPD and in patients with asthma receiving Breztri under the approved indication(s) in Korea over a 24-week follow-up period, or until the end of treatment (EoT) if discontinued earlier. The secondary objective of this study is to describe changes in clinical outcomes from baseline to week 12 and week 24, separately in patients with COPD and in patients with asthma 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 clinical outcomes separately in patients with COPD and in patients with asthma receiving Breztri under the approved indication(s) in Korean patients.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Patients who have been diagnosed with COPD or asthma. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence proportion of Adverse Events (AEs)/Adverse Drug Reactions (ADRs) | 24 weeks | 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. |
| Incidence proportion of Serious AEs (SAEs)/Serious ADRs (SADRs) | 24 weeks | 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. |
| Incidence proportion of Unexpected AEs/Unexpected ADRs | 24 weeks | 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. |
| Incidence proportion of Unexpected SAEs/Unexpected SADRs | 24 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 12 and 24 weeks | 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. |
| Change from baseline to week 12 and 24 in COPD Assessment Test (CAT) score | 12 and 24 weeks | 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. |
| 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 | 12 and 24 weeks | 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". |
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed