NCT01804400已完成2 期
A Randomized, Double-blind, Placebo-controlled Three-period Incomplete Cross Over Study to Compare the Efficacy of QAW039 Alone and in Combination With Montelukast in Patients With Allergic Rhinitis Using an Environmental Exposure Chamber
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
- 188
- 试验地点
- 1
- 主要终点
- Change in Total Nasal Symptom Score from baseline at 14 days
研究概览
简要总结
This study will assess the safety and efficacy of QAW039 alone and in combination with Montelukast in patients with allergic rhinitis (hay fever) using an environmental exposure chamber.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18-65 years inclusive, with a clinical history of intermittent allergic rhinitis with seasonal onset and offset of nasal allergy symptoms during each of the last two grass pollen allergy seasons.
- •A positive skin prick test at Visit 1 to dactylis glomerata with a wheal diameter equal to or greater than 3 mm and a negative control with a wheal diameter of zero. A positive skin prick test within 12 months prior to Visit 1 is also acceptable.
- •FEV1 measured by spirometry must be ≥80% of their predicted value at screening. If the patient does not achieve ≥80% of their predicted value this may be repeated prior to the EEC challenge at visit
- •TNSS score ≥6 on at least one assessment during the 2h EEC challenge at Screening.
排除标准
- •Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations.
- •Pregnant or nursing (lactating) women,
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.
研究组 & 干预措施
QAW039 + Montelukast
Experimental
干预措施: Montelukast (Drug)
QAW039 + Montelukast
Experimental
干预措施: QAW039 (Drug)
QAW039 + Montelukast
Experimental
干预措施: Placebo (Drug)
QAW039 Once a day (q.d.)
Experimental
干预措施: QAW039 (Drug)
QAW039 Once a day (q.d.)
Experimental
干预措施: Placebo (Drug)
QAW039 Twice a day (b.i.d.)
Experimental
干预措施: QAW039 (Drug)
QAW039 Twice a day (b.i.d.)
Experimental
干预措施: Placebo (Drug)
Montelukast
Active Comparator
干预措施: Montelukast (Drug)
Montelukast
Active Comparator
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Total Nasal Symptom Score from baseline at 14 days
时间窗: Baseline, Day 14
Total Nasal Symptom Score (TNSS) averaged over the last two hours (2-4h) of exposure following 14 days treatment with QAW039 and/or Montelukast or matched placebo
次要结局
- Change in Nasal Flow from baseline at 14 days(Prior to, and every 60 min during allergen exposure period)
- Change in Total Ocular Symptom score from Baseline at 14 days(Baseline, Day 14)
- Change in Nasal excretion weight from baseline at 14 days(Baseline, Day 14)
- Change in Forced Expiratory Volume in 1 Second (FEV1) from baseline at 14 days(Baseline, Day 14)
- Change in FEV1/FVC at from baseline at 14 days(Baseline, Day 14)
- Plasma Concentration maximum (Cmax)(Day 1-14)
- Plasma Concentration Minimum (Cmin)(Day 1-14)
- Change in Forced Vital Capacity (FVC) from baseline at 14 days(Baseline, Day 14)
- Plasma Concentration Average (Cav)(Day 1-14)
- Time of Cmax (Tmax)(Day 1-14)
- Area Under Curve (AUCtau)(Day 1-14)
研究者
研究点 (1)
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