Exacerbations and Real-World Outcomes Among Patients With Chronic Obstructive Pulmonary Disease Following Severe Exacerbation (MITOS:EROS+DISCHARGE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 3,598
- 试验地点
- 1
- 主要终点
- Annualized COPD Exacerbation Event Rate
研究概览
简要总结
This real-world retrospective study will use de-identified administrative claims data and will examine patients with a diagnosis of COPD who have experienced a qualifying severe disease exacerbation and received subsequent treatment with BGF. Agreed COPD patient data from the Inovalon MORE2 Registry® and Centers for Medicare & Medicaid Services (CMS) 100% Medicare Fee for Service (FFS) database spanning from January 1, 2021 to the most recently available data (September 30th, 2024 for the MORE2 database, and December 31st, 2023 for the Medicare FFS database) will be used for this analysis. All patients will be required to present at least one prescription claim for BGF. Patients will also be required to show evidence of a qualifying severe COPD exacerbation event during the 180-day period preceding initiation of BGF. Index date will be set as the date of discharge from the qualifying severe exacerbation event.
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 January 1, 2021
- •Patients must have evidence of a severe qualifying exacerbation event.
- •The qualifying severe exacerbation event discharge date must occur within the 180-day period preceding the initiation of BGF for classification of patients into prompt or delayed initiators of BGF.
- •The discharge date of the first (earliest) observed qualifying index exacerbation event will be set as the index date
- •≥ 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 date
排除标准
- •Presence of cancer diagnoses other than basal or squamous cell skin cancer during the baseline period preceding the index date or entire follow-up period
- •Presence of ≥2 claims with a diagnosis of interstitial fibrosis or sarcoidosis diagnoses during the period preceding the index date or entire follow-up period
- •Presence of SITT at any time during the entire available history of patients' data preceding the index date through BGF initiation
研究组 & 干预措施
Prompt
Patients initiating BGF within 30-days of exacerbation
干预措施: BGF- BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL (Drug)
Delayed
Patients initiating BGF within 31-180 days of exacerbation
干预措施: BGF- BUDESONIDE/GLYCOPYRRONIUM/FORMOTEROL (Drug)
结局指标
主要结局
Annualized COPD Exacerbation Event Rate
时间窗: 180 days
Annualized rates of COPD exacerbation events observed from index date (qualifying exacerbation event) through study completion (or until end of data availability
次要结局
- Annualized Cardiopulmonary Event Rate(180 days)
- Annualized rate of all-cause mortality(180 days)