NCT00322283已完成2 期
Efficacy and Safety of Oglemilast in the Prevention of Exercise-Induced Bronchospasm
Forest Laboratories1 个研究点 分布在 1 个国家目标入组 24 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
- 24
- 试验地点
- 1
- 主要终点
- To determine the efficacy of oglemilast as compared to placebo in preventing exercise-induced asthma following 15 days of treatment.
研究概览
简要总结
The purpose of this study is to determine whether it is effective in the treatment of exercise-induced asthma and investigate the safety of oglemilast.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •stable mild asthma patients who exhibit at least a 20% decrease in FEV1 following exercise.
排除标准
- •pulmonary disease other than asthma, psychiatric illness, active cardiac disease, high blood pressure, history of substance abuse, current smokers.
研究组 & 干预措施
Oglemilast
Experimental
干预措施: Oglemilast (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
To determine the efficacy of oglemilast as compared to placebo in preventing exercise-induced asthma following 15 days of treatment.
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.
研究者
研究点 (1)
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