NCT00322686已完成2 期
Efficacy and Safety of Oglemilast in the Prevention of Allergen-induced Bronchospasm
Forest Laboratories1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2006年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- To determine the effect of oglemilast in the prevention of bronchoconstriction after the administration of allergen, in comparison with placebo in patients with mild asthma
研究概览
简要总结
The purpose of this study is to determine whether oglemilast is safe and effective in the treatment of allergen-induced asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild atopic asthma
- •Hyperreactivity to methacholine
- •Exhibit positive response to standard allergen skin prick test
排除标准
- •Pulmonary disease other than asthma
- •Asthma exacerbation within 4 weeks
- •History of substance abuse
- •Active cardiac disease
研究组 & 干预措施
Oglemilast followed by placebo
Experimental
干预措施: Oglemilast (Drug)
Placebo followed by Oglemilast
Experimental
干预措施: Placebo then Oglemilast (Drug)
结局指标
主要结局
To determine the effect of oglemilast in the prevention of bronchoconstriction after the administration of allergen, in comparison with placebo in patients with mild asthma
时间窗: From Baseline to Day 7
次要结局
- To evaluate the safety of oglemilast over 2 weeks as determined by adverse events,physical examinations, vital signs, electrocardiograms, and laboratory examinations(From Baseline to Day 14)
研究者
研究点 (1)
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