EXACERBATIONS AND REAL-WORLD OUTOMES INCLUDING CARDIOPULMONARY EVENTS AMONG PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE INITIATING BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL (MITOS: EROS+CP US Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 13,000
- 试验地点
- 1
- 主要终点
- Annualized COPD Exacerbation Event Rate
研究概览
简要总结
A retrospective real-world data study, assessing the relationship between the timing of Budesonide/Glycopyrrolate/Formoterol initiation following an exacerbation and the occurrence of subsequent exacerbations, severe cardiopulmonary events and other real-world outcomes in the United States
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1 prescription(s) fill for BGF on or following July 24, 2020 (date of BGF approval in the United States)
- •Patients must have evidence a qualifying exacerbation events which, per local or global guidelines, would qualify a patient to have treatment escalated or initiated to triple therapy. The qualifying exacerbation event must occur within the 12-month period preceding the initiation of BGF but occurring on or following local BGF commercial availability (July 24, 2020) and includes either of the following
- •12 months of continuous health plan enrollment preceding the qualifying index exacerbation event date ('baseline' period)
- •1 day of continuous enrollment following the qualifying index exacerbation date
- •Age ≥ 40 years on the qualifying index exacerbation event
排除标准
- •Presence of cancer diagnoses other than basal or squamous cell skin cancer during the baseline or follow-up periods
- •Presence of interstitial fibrosis, sarcoidosis, or pulmonary embolism diagnoses during the baseline or follow-up periods
- •Presence of triple therapy SITT during the baseline period through BGF initiation
研究组 & 干预措施
Prompt
PATIENTS INITIATING BGF WITHIN 30-DAYS OF EXACERBATION
干预措施: BGF (Drug)
DELAYED
PATIENTS INITIATING BGF WITHIN 31-180 DAYS OF EXACERBATION
干预措施: BGF (Drug)
VERY DELAYED
PATIENTS INITIATING BGF WITHIN 181-365 DAYS OF EXACERBATION
干预措施: BGF (Drug)
结局指标
主要结局
Annualized COPD Exacerbation Event Rate
时间窗: Annualized rates from index exacerbation through end of data availability, mean follow-up 462 days
Annualized rates of COPD exacerbation events observed from index date (qualifying exacerbation event) through study completion (or until end of data availability; mean follow-up 462 days
次要结局
- Annualized Cardiopulmonary Event Rate(Annualized rates from index exacerbation through end of data availability; mean follow-up 462 days)