CTRI/2014/11/005164已完成4 期
A prospective, open label, non-comparative, observational, 24 weeks multicentre study ofFluticasone/Formoterol (Maxiflo®) FDC Rotacaps (100/6 mcg and 250/6 mcg) when taken through Revolizer® in patients with persistent asthma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Cipla Ltd
- 入组人数
- 400
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. Patients and/or LAR willing to give voluntarily signed informed consent.
- •2. Patients of both the sex above 18 years of age.
- •3. Confirmed diagnosis of asthma (As per Revised GINA 2012) and able to
- •use the Breath-o-meter® and Revolizer®dry powder inhaler correctly.
- •4. Patients who are already prescribed Fluticasone/Formoterol (Maxiflo®) at
- •any dose through Revolizer® (dry powder inhaler device) as a part of
- •standard of care based upon asthma severity or patients who are
- •uncontrolled on other treatment through Revolizer® and requires a change
- •in their treatment to Fluticasone/Formoterol FDC as per treating physicians
- •discretion.
排除标准
- •1. Any chronic respiratory disease other than asthma.
- •2. Known or suspected hypersensitivity to combination or any other
- •constituent of Fluticasone/FormoterolFDCRotacaps.
- •3. On any medication documented to have a drug interaction with
- •Fluticasone/FormoterolFDC.
- •4. Females who are pregnant, lactating or planning to become pregnant
- •5. Patients who are scheduled to receive any other investigational drug during
- •the course of the study
- •6. Treatment with any investigational drug in last 30 days prior to
- •screeningvisit 1.
- •7. Patients having a smoking history of >= 10 pack years.
研究者
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