NCT00856687已完成1 期
A Randomized, Double-Blind (3rd Party Open), Double-Dummy, Placebo- And Active Controlled, 3-Way Crossover Study To Determine The Effects Of Oral PF-03893787 On Allergen-Induced Airway Responses In Mild Asthmatic Subjects.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Spirometry pre- and post- bronchial allergen challenge
研究概览
简要总结
PF-03893787, a novel anti-inflammatory agent should attenuate the effect of a bronchial allergen challenge on lung function and hence provide proof of mechanism for this agent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females 18-60 years.
- •Mild asthma
- •Atopic to allergens
排除标准
- •Unstable asthma.
- •Smokers or recent ex-smokers
- •Recent allergen challenge
研究组 & 干预措施
PF-03893787
Experimental
干预措施: PF-03893787 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Montelukast
Active Comparator
干预措施: Montelukast (Drug)
结局指标
主要结局
Spirometry pre- and post- bronchial allergen challenge
时间窗: 2 months
次要结局
- Laboratory safety tests(2 months)
- 12-lead ECGs(2 months)
- Adverse Event reporting(2 months)
- Blood samples for pharmacokinetic measurement(2 months)
研究者
研究点 (1)
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