CTRI/2015/01/005453已完成4 期
A prospective, open label, non-comparative, observational, 24 weeks multi centre study of Triohale®(Ciclesonide/Formoterol/Tiotropium FDC) administered through pressurized meter dose inhaler(pMDI) with or without spacer or dry powder inhaler in patients with COPD.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Cipla Ltd
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1. Patient is ready to sign informed consent form
- •2. Patients of either sex above 40 years of age with a confirmed diagnosis of COPD (GOLD updated January 2014)
- •3. Patient able to use the Revolizer or Rotahaler dry powder inhaler, pMDI or pMDI with spacer and perform the Spirometry.
- •4. Triohale®/triple therapy naïve patients who are assessed to benefit from the intake of Triohale® (Investigator adjudicated need to step-up to triple therapy due to increased symptoms or clinical deterioration or frequent exacerbation).
排除标准
- •1. Patient Known or suspected hypersensitivity to combination or any other constituents of the Investigational Medicinal Product (IMP) & study drugs.
- •2. Actively participating in any clinical trial or participated in past 1 month
研究者
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