A U.S. Retrospective Database Analysis Evaluating the Comparative Effectiveness of Budesonide/Formoterol (BFC) vs. Fluticasone/Salmeterol (FSC) Combination in Patients With COPD.

AstraZeneca0 个研究点目标入组 3,000 人开始时间: 2013年8月最近更新: 2016年2月3日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: AstraZeneca
入组人数: 3,000
主要终点: Rate of COPD exacerbation

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study is intended to evaluate treatment effectiveness of BFC compared to FSC in COPD patients new to ICS/LABA combination therapy.

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 for BFC or FSC during intake period, naive to ICS/LABA therapies in year prior to first prescription claim, COPD diagnosis, aged 40 or over at time of first prescription.

排除标准

•ICS/LABA combination during pre-index period, patients with a claim for BFC and FSC 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

Rate of COPD exacerbation

时间窗: 12 months

The rate of COPD exacerbation will be defined as the total number of COPD exacerbations during the post-index period for all patients in each treatment cohort divided by the total number of person years. 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

All-cause utilization(12 months)
Treatment patterns and adherence(12 months)
Treatment modification(12 months)
COPD respiratory medication use(12 months)
COPD related healthcare utilization(12 months)
All- cause and COPD related healthcare costs(12 months)
COPD exacerbation rate sensitivity analysis(up to 4 years)
COPD exacerbation rate sensitivity and subgroup analyses(12 months)

研究者

发起方

AstraZeneca

申办方类型

Industry

责任方

Sponsor

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