A U.S. Retrospective Database Analysis Evaluating the Comparative Effectiveness of Budesonide/Formoterol (BFC) and Tiotropium Bromide Among COPD Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 2,396
- 主要终点
- Time to first COPD exacerbation
研究概览
简要总结
This study is intended to evaluate treatment effectiveness with budesonide/formoterol (BFC) and tiotropium tromide in patients new to ICS/LABA combination and LAMA therapies.
详细描述
Using US claims data from the HealthCore Integrated Research Environment, COPD patients ≥40 years old initiating BFC or tiotropium between 3/1/2009-2/28/2012 and considered at risk for a future exacerbation were identified and followed for 12 months.
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
- •Continuous health plan enrollment for 12 months before and after index Rx
- •At least one prescription fill for BFC or tiotropium bromide during intake period, and naive to ICS/LABA combination or LAMA therapies in year prior to first prescription claim.
- •COPD diagnosis, and aged 40 years of age at time of first prescription
- •At risk population for COPD exacerbations
排除标准
- •ICS/LABA combination or LAMA therapy during pre-index period
- •Patients with prescription claim for budesonide/formoterol and tiotropium bromide on the same day
- •Patients diagnosed with cancer
- •Patients with long-term OCS medication use during pre-index period
结局指标
主要结局
Time to first COPD exacerbation
时间窗: 12 months
The time to first COPD exacerbation will be calculated as the date of first COPD exacerbation minus index date. A COPD exacerbation event is defined as any of three conditions: COPD related inpatient hospitalization, COPD related emergency department visit, or COPD outpatient/office visit with a pharmacy claim for OCS and/or antibiotics on the same day or within ten days.
次要结局
- COPD exacerbation rates(12 months)
- COPD respiratory medication use(12 months)
- COPD related utilization(12 months)
- All-cause utilization(12 months)
- All-cause and COPD related healthcare costs(12 months)
- Treatment patterns and adherence(12 months)
- Treatment modification(12 months)