Pooled Analysis of Multi-country, Open-label Single-arm, Non-interventional, Multi-center, Cohort Studies of Real-world Outcomes in New Users of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 2,000
- 试验地点
- 8
- 主要终点
- COPD Assessment Test (CAT)
研究概览
简要总结
The CHOROS pooled analysis is a retrospective secondary data use analysis of integrated individual participant data from a series of planned and on-going primary prospective, non-interventional, multi-center studies sponsored by AstraZeneca and conducted in the pulmonary/primary care practitioner setting in multiple countries and may include data from the following countries: United Kingdom, Germany, Italy, Greece, Japan, Canada and Romania.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with moderate to severe COPD and initiating BGF treatment according to the local prescribing guidance and as per their treating physician's recommendation
- •Enrolled in on-going single-arm studies
- •Provided consent for secondary use of data
排除标准
- •Did not provide consent for secondary use of data
研究组 & 干预措施
BGF Initiators
New initiators of BGF without prior BGF exposure
干预措施: Budesonide/glycopyrrolate/formoterol fumarate (Drug)
结局指标
主要结局
COPD Assessment Test (CAT)
时间窗: 12 weeks
Compare self-reported COPD health status measured by COPD Assessment Test (CAT) at 12 weeks/3 months as compared to baseline in patients initiating treatment with BGF
次要结局
- COPD Assessment Test(52 weeks)
- COPD Assessment Test Responder Rate(12 weeks)
- Treatment Satisfaction Questionnaire for Medication (TSQM)(12 weeks and 52 weeks)
- Annual rate of COPD exacerbations(52 weeks)
- COPD Assessment Test(4 weeks)