Adherence and COPD Exacerbation Rates in Patients Initiating ICS/LABA Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Exacerbation rate
研究概览
简要总结
The purpose of this retrospective, non-interventional sutdy is to compare the effectiveness of ICS/LABA combination therapy in the reduction of COPD exacerbations during the 12 months after initiation of therapy between COPD patients who are adherent to the index medication and those who are non-adherent.
详细描述
This retrospective, observational study will assess the effectiveness of ICS/LABA combination therapies among COPD patients new to the ICS/LABA combination therapies in the US, comparing those who are adherent to the index medication and those who are non-adherent. Adherence will be measured using the proportion of days covered with the index medication. Medical and pharmacy claims data will be used as the data source.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least one prescription fill for ICS/LABA combination during identification period.
- •COPD diagnosis
- •40 years or older at index date
- •> or = 12 months of continuous health plan enrollment prior to and following index date
- •1 or more prescription for SABA, SAMA or SABA/SAMA during the pre-index period.
排除标准
- •Patients with prescription claim for ICS/LABA combination therapy during the 12 month pre-index period
- •Patients receiving oral corticosteroid medication for more than 180 days during the 12 month pre-index period
- •Patients with cancer diagnosis in 12 month pre-index period
结局指标
主要结局
Exacerbation rate
时间窗: 12 months
Rate of COPD exacerbation occurring during the 12 months after therapy initiation.
次要结局
- Severe Exacerbation rate(12 months)