NCT00468975已完成2 期
A Phase IIA Randomised, Double-blind, Double Dummy, Placebo and Active Controlled 5-Way Cross-over Trial to Examine the Bronchodilator Effects of PF-610,355 and to Test for Superiority Versus Placebo in Reversible Asthmatic Patients
适应症
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
- 42
- 试验地点
- 7
- 主要终点
- Peak and Trough (24 hour post dose) FEV1.
研究概览
简要总结
A study to determine the ability of different doses of PF-610,355 to open the airways in asthmatic patients by comparison with placebo and a marketed drug that also opens the airways in asthmatic patients.
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Reversible asthmatic patients (>15% increase in FEV1 following 200ug salbutamol).
- •FEV1 greater than or equal to 60% predicted
- •Stable disease for at least the previous 3 months
排除标准
- •Subjects requiring rescue medication on greater than 2 occasions in the 72 hours prior to screening
- •Subjects with a history of pulmonary disease other than asthma.
结局指标
主要结局
Peak and Trough (24 hour post dose) FEV1.
次要结局
- FEV1 and PEFR measurements to 32 hours post dose.
- Safety/Pharmacodynamic end points - pulse rate, blood pressure, QTcF, plasma potassium, blood glucose and AEs.
- Pharmacokinetics of PF-610,355 and salmeterol
- Peak and trough (24 hour post dose) PEFR
研究者
研究点 (7)
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