BREZTRI REGULATORY POST MARKETING SURVEILLANCE IN KOREA
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- AstraZeneca
- 入组人数
- 600
- 主要终点
- Incidence proportion of Adverse Events (AEs)/Adverse Drug Reactions (ADRs)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Other off-label indications outside of the locally approved prescribing information
- •Pregnant and/or breast feeding
- •Current participation in any interventional trial
研究组 & 干预措施
Chronic obstructive pulmonary disease
Patients who have been diagnosed with COPD
Asthma
Patients who have been diagnosed with asthma
结局指标
主要结局
Incidence proportion of Adverse Events (AEs)/Adverse Drug Reactions (ADRs)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Change from baseline to week 12 and 24 in pre-dose Forced Expiratory Volume in 1 second (FEV₁)(12 or 24 weeks)
- Change from baseline to week 12 and 24 in COPD Assessment Test (CAT) score(12 or 24 weeks)
- 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 in COPD Assessment Test (CAT) score(12 and 24 weeks)
- 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)