ISRCTN29389604已完成未知
An exploratory, randomised, double-blind, placebo controlled, 14 day, two-way crossover, Inhaled Allergen Challenge (IAC) study to evaluate the effects of SMP-028 in subjects with mild to moderate asthma
Dainippon Sumitomo Pharma Europe Ltd (UK)0 个研究点目标入组 24 人开始时间: 2009年11月11日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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
- 性别
- All
入选标准
- •1. Male or female (of non childbearing potential) subjects aged between 18 and 65 years who have documented history of bronchial asthma
- •2. Demonstration of a positive wheal reaction to at least 1 of 3 allergens (house dust mite, grass pollen, cat hair and dander) on skin prick testing
- •3. Screening allergen challenge demonstrating that the subject experiences both an early and late asthmatic response.
- •4. Body mass index (BMI) within the range 19.0 - 32.0 kg/m^2 (inclusive)
- •5. Sensitivity to AMP with a provocative concentration of AMP
排除标准
- •1. Past or present disease which, as judged by the Investigator, may affect the outcome of this study
- •2. Subject has known history of uncontrolled hypertension or is hypertensive at the Screening visit
- •3. Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study drug
- •4. Symptomatic allergic rhinitis
- •5. History of life-threatening asthma
研究者
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