EXACERBATIONS AND REAL-WORLD OUTOMES INCLUDING CARDIOPULMONARY EVENTS AMONG PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE INITIATING BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL (MITOS: EROS+CP Japan Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 3,402
- 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 Japan
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
- •Diagnosis of COPD (at any position) before or on the index date
- •1 dispensation of BGF on or following the launch date of BGF in Japan
- •Patients must have evidence of at least one qualifying COPD exacerbation event, which qualify the initiation of triple therapy. The exacerbation event must occur within the 12-month period preceding BGF initiation and on or after BGF launch in Japan (i.e., 04 September 2019). The earliest qualifying COPD exacerbation event will be set as the index date.
- •12 months of continuous health plan enrollment preceding the qualifying COPD exacerbation date
- •1 day of continuous enrollment following the qualifying COPD exacerbation date
- •Age ≥ 40 years on the qualifying COPD exacerbation date
排除标准
- •Presence of ≥ 2 records of respiratory cancer diagnoses occurring at least 1 month apart during the 12-month baseline period preceding the qualifying COPD exacerbation or during the follow-up period
- •Presence of ≥ 1 dispensation of SITT during the 12-month baseline period preceding the index date through BGF initiation
- •Patients who only have 1 moderate COPD exacerbation in 12-months period prior to BGF initiation with no dispensation of long-acting inhaled COPD maintenance treatment during the 12-months baseline period preceding the qualifying COPD exacerbation.
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 BETWEEN 181 AND 365 DAYS AFTER 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; median follow-up 713 days
Annualized rates of COPD exacerbation events observed from index date (qualifying exacerbation event) through study completion (or until end of data availability with a median follow-up of 713 days
次要结局
- Annualized Cardiopulmonary Event Rate(Annualized rates from index exacerbation through end of data availability with median follow-up of 713 days)