跳至主要内容
临床试验/CTRI/2015/01/005453
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.

Cipla Ltd0 个研究点目标入组 300 人开始时间: 待定最近更新:

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

发起方
Cipla Ltd

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