CTRI/2010/091/001467招募中3 期
?AN OPEN LABEL, RANDOMIZED, MULTICENTRIC, PHASE-III TRIAL TO COMPARE THE EFFICACY, TOLERABILITY, AND SAFETY ACEBROPHYLLINE + MONTELUKAST VRS ACEBROPHYLLINE IN THE TREATMENT OF BRONCHIAL ASHTHMA?
Ravenbhel Healthcare Pvt Ltd0 个研究点目标入组 200 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •■All patients with duly filled in ICFs [Informed Consent Forms]
- •■Ages: > 15 years and < 80 years
- •■Genders Eligible for Study: both
- •■The patients who had been prescribed asthma medication for 1 year or more
- •■The patients with FEV1 of 50% or more of predicted values.
- •■The patients with a poor asthma control defined by a score of 1.5 or greater on the Asthma Control Questionnaire [ACQ]
- •■Female patients still menstruating with acceptable mode of contraception
排除标准
- •?Patients unwilling to sign on ICF
- •?Participation in other trials,
- •?Patients with a history or showing the presence of other lung disease that would be responsible for bronchial asthma
- •?Patients having received oral corticosteriods, leukotriene antagonist or Acebrophylline within 28 days of commencement of trial
- •?Patients having previous or current smoking history of more than 10 cigarrettes per day
- •?Patients requiring aspirin, corticosteroids, warfarin, ticlopidine or any other drug that affects absorption of the study drugs
- •?Pregnancy or breast feeding,
- •?Inadequate contraception,
- •?Dementia, Depression or any other functional disorder
- •?Alcohol or drug dependence,
- •?Concomitant serious medical condition,
- •?Hypersensitivity to Acebrophylline or Montelukast or any other leukotriene antagonists
- •?Any other serious diseases having fatal progression.
- •?Clear diagnosis of kidney or liver disease, abnormal kidney or liver function.
研究者
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