NCT01253603已完成2 期
A Randomized, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety, and Pharmacokinetics of QAW039 in Steroid-free Patients With Mild to Moderate Persistent Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Change in trough forced expiratory volume in 1 second (FEV1) compared to placebo.
研究概览
简要总结
This study will assess the safety, efficacy and pharmacokinetics of QAW039 in steroid-free patients with mild to moderate persistent 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 a medical history of mild to moderate persistent allergic asthma.
- •Patients must weigh at least 45 kg to participate in the study, and must have abody mass index (BMI) of >17 kg/m
- •Female patients must be surgically sterilized, postmenopausal or using a double-barrier method of contraception
排除标准
- •Women of child-bearing potential.
- •Smokers defined as history of smoking in the previous 6 months or a smoking history of more than 10 pack years, a pack year being defined as smoking the equivalent of 20 cigarettes - a pack - every day for the period of 1 year
- •Patients with severe persistent asthma
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
1
Experimental
QAW039 capsules once daily for 28 days
干预措施: QAW039 capsules once daily for 28 days (Drug)
2
Experimental
Placebo to QAW039 capsules once daily for 28 days
干预措施: Placebo to QAW039 capsules once daily for 28 days (Drug)
3
Experimental
Fluticasone propionate inhaler twice daily for 28 days
干预措施: Fluticasone propionate inhaler twice daily for 28 days (Drug)
结局指标
主要结局
Change in trough forced expiratory volume in 1 second (FEV1) compared to placebo.
时间窗: 28 days
次要结局
- To assess the safety of a 28 day administration of QAW039 compared to placebo, measured by vital signs, laboratory evaluations and electrocardiograms.(28 days)
研究者
研究点 (2)
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