NCT01103037终止2 期
A Randomized, Double-blind, Parallel Group Study to Compare the Pharmacodynamics/Efficacy, Safety and Pharmacokinetics of QAV680 Versus Placebo in Patients With Moderate Persistent Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 4
- 主要终点
- Change in Forced Expiratory Volume in one second (FEV1) as measured by Spirometry
研究概览
简要总结
This study will assess the safety and efficacy of QAV680 in patients with mild to moderate asthma
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Patients with moderate persistent asthma
排除标准
- •Any significant disease or illness, other than asthma
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
QAV680
Experimental
干预措施: QAV680 (Drug)
QAV680 Placebo
Placebo Comparator
干预措施: QAV680 Placebo (Drug)
结局指标
主要结局
Change in Forced Expiratory Volume in one second (FEV1) as measured by Spirometry
时间窗: 28 days
次要结局
- Total serum IgE levels(28 days)
- FEV1 assessments at various timepoints including time of peak drug concentration(28 days)
- Measure the change in exhaled Nitric Oxide (FeNO)(28 days)
- Change in daily variability in the morning and evening Peak Expiratory Flow Rate (PEFR) from Baseline.(28 days)
- Assessment of the pharmacokinetics of multiple doses of QAV680 in patients with mild to moderate asthma.(28 days)
研究者
研究点 (4)
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