A U.S. Retrospective Database Analysis Evaluating the Comparative Effectiveness of Budesonide/Formoterol Combination (BFC) and Fluticasone Propionate/Salmeterol Combination (FSC) Among Asthma Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 6,086
- 主要终点
- Rate of asthma exacerbations
研究概览
简要总结
The objective of this study is to compare the real-world effectiveness of BFC and FSC in asthma patients new to ICS/LABA combination therapy in a population of U.S. health plan enrollees.
详细描述
A U.S. retrospective database analysis evaluating the comparative effectiveness of budesonide/formoterol and fluticasone propionate/salmeterol among asthma patients
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
- 12 Years 至 64 Years（Child, 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 two prescription fills for BFC or FSC within 12 months
- •Asthma claims diagnosis, and 12 to 64 years of age at the time of first prescription
排除标准
- •Evidence of COPD
- •Claims diagnosis of any of inflammatory diseases or cancer
- •Presence of Rx for more than one type of ICS/LABA combination on index date
- •Chronic steroid use or Xolair use prior to ICS/LABA index treatment
结局指标
主要结局
Rate of asthma exacerbations
时间窗: 12 months
The rate is defined as the total number of asthma exacerbations for all patients in the cohort divided by the total number of person years. An asthma exacerbation is defined as any of three conditions: Asthma related inpatient hospitalization or Asthma related emergency department visit or Oral corticosteroid use.
Asthma Related Inpatient Hospitalizations
时间窗: 12 months
Asthma Related Emergency Department visits
时间窗: 12 months
Use of Oral Corticosteroids (OCS)
时间窗: 12 months
A pharmacy claim for any of the OCS medications
次要结局
- Asthma controller medication use (SABA, ICS, LABA, LTRA, XOLAIR, THEOPHYLLINE)(12 months)
- Asthma Related Healthcare Utilization(12 months)
- Asthma Related Healthcare costs(12 months)