NCT00723021已完成2 期
A Phase 2a, Randomised, Double-Blind (3rd Party Open), Double-Dummy, Placebo And Active Controlled 5-Way Crossover Study To Assess The Bronchodilatory Action, Safety, Toleration And Pharmacokinetics Of Single Oral Doses Of PF-04191834 In Asthmatic Patients.
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
- Pfizer
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
研究概览
简要总结
Study to determine the bronchodilatory effects of PF-04191834 compared with zileuton in patients with asthma
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Persistent mild/moderate asthma for at least 6 months.
- •Reduced lung function
- •Reversible airway obstruction
排除标准
- •Pregnant/nursing females.
- •Liver function tests greater than upper limit of normal (ULN)
研究组 & 干预措施
PF-04191834 30mg
Experimental
干预措施: PF-04191834 (Drug)
PF-04191834 100mg
Experimental
干预措施: PF-04191834 (Drug)
PF-04191834 2000mg
Experimental
干预措施: PF-04191834 (Drug)
zileuton
Active Comparator
干预措施: zileuton (Drug)
placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
时间窗: Baseline, 24 hours (hrs) post-dose
The FEV1 is the maximal volume of air that can be forcefully exhaled in one second
次要结局
- Change From Baseline in Forced Vital Capacity (FVC)(Baseline,24 hours (hrs) post-dose)
- Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75)(Baseline, 24 hours (hrs) post-dose)
研究者
研究点 (1)
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