The Role of Inhaler Device in the Treatment Persistence With Dual Bronchodilators in Patients With COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11,296
- 试验地点
- 1
- 主要终点
- Rate of Discontinuation of Index Treatment (Olodaterol/Tiotropium Bromide or Umeclidinium/Vilanterol)
研究概览
简要总结
To compare the persistence in using two different medications from the same drug class (LAMA/LABA FDC) which are delivered through different devices, a dry-powder inhalers (DPI) and Soft Mist Inhalers (SMI).
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
- 1 Year 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Aged <40 years
- •Enrolment with medical and pharmacy coverage prior to the cohort entry < 180 days
- •Never had COPD diagnosis on the cohort entry date or prior to cohort entry
- •A record for dispensed Olodaterol/Tiotropium Bromide delivered with Respimat inhalator or Umeclidinium/Vilanterol delivered with the Ellipta Inhaler during the 180-day baseline prior to cohort entry
- •Diagnosis of asthma any time prior to cohort entry
- •Diagnosis of lung cancer any time prior to cohort entry
- •Diagnosis of lung transplant any time prior to cohort entry
研究组 & 干预措施
Subjects with Chronic obstructive pulmonary disease
干预措施: Olodaterol/Tiotropium Bromide (Drug)
Subjects with Chronic obstructive pulmonary disease
干预措施: Umeclidinium/ Vilanterol (Drug)
结局指标
主要结局
Rate of Discontinuation of Index Treatment (Olodaterol/Tiotropium Bromide or Umeclidinium/Vilanterol)
时间窗: From first day after the cohort entry date to the earliest occurence of the outcome (discontinuation or refills), or any censoring criteria (365 days of follow-up without discontinuation, death, disenrollment end of data).
The primary outcome of interest was discontinuation of index treatment (Olodaterol/Tiotropium Bromide or Umeclidinium/Vilanterol), defined as persistence, (i.e. no refill Claim within 60 days \[not including treatment Switch, nor death\] after end of supply) during follow-up. Persistence was assessed by calculating rates of discontinuation in the matched cohorts using a 60-day allowable gap. Rates of discontinuation are reported as the number of events divided by the number of Person-years at risk. Addition of another treatment to index treatment did not count as discontinuation.
次要结局
未报告次要终点