跳至主要内容
临床试验/NCT03692676
NCT03692676已完成不适用

Characteristics of Patients Initiating Spiriva Respimat in Asthma in the UK: a Cross-sectional Study Based on the Clinical Practice Research Datalink

Boehringer Ingelheim1 个研究点 分布在 1 个国家目标入组 116,133 人开始时间: 2019年3月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
116,133
试验地点
1
主要终点
Number of Participants With Cardiac Arrhythmias

研究概览

简要总结

This study is a cross-sectional, non-interventional study based on existing data (NISed).

详细描述

The UK CPRD data will be used to assess the characteristics of asthma patients who were prescribed ICS/LABA FDC before the index date and who initiated Spiriva Respimat, or received a higher dose of ICS/LABA FDC, or initiated LTRA, or switched to a new ICS/LABA FDC in the UK during the study period (September 2014-December 2017) enabling to assess potential channeling of prescribing to different patient populations.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 years and above at the index date
  • At least 12 months of continuous registration prior to the index date in a practice contributing up to standard (UTS) data to the Clinical Practice Research Database (CPRD)
  • Had a diagnosis of asthma before the index date
  • Being treated with Inhaled corticosteroids/Long-acting beta agonists (ICS LABA FDC) before the index date (at least one prescription within 3 months before the index date)
  • Patients who were new users of Spiriva Respimat, or LTRA, or patients who were prescribed a higher dose of ICS/LABA FDC, or patients who switched to a new ICS/LABA FDC from the previous ICS/LABA FDC

排除标准

  • Patients who were prescribed other Long-acting muscarinic antagonists (LAMA) any time before or on the index date
  • In the primary analysis, patients who were diagnosed with COPD before or on the index date will be excluded from the study. In a sensitivity analysis, patients who had both asthma and COPD diagnoses will be included in the study

结局指标

主要结局

Number of Participants With Cardiac Arrhythmias

时间窗: On the index date or in the year prior to the index date

The number of participants who had Cardiac arrhythmias on the index date or in the year prior to the index date.

次要结局

  • Number of Participants With Cardiac Failure(On the index date or in the year prior to the index date)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验