NCT01103050已完成2 期
A Randomized, Double-blind, Double-dummy, Placebo Controlled Three-period Incomplete Cross Over Study to Compare the Effect of Combined Treatment With QAV680 and Cetirizine on Total Nasal Symptom Score in Allergic Rhinitis Patients in 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
- 60
- 试验地点
- 1
- 主要终点
- Total Nasal Symptom Score measured during allergen exposure
研究概览
简要总结
This study will determine the capacity of more frequent dosing of QAV680 to suppress allergic inflammation. The study will investigate the paradigm of multiple receptor antagonism in allergic disease by combining QAV680 with a second generation H1 histamine receptor antagonist to assess possible additive or synergistic anti-allergic effects of the two compound classes.
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
- Triple (Participant, Care Provider, 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 clinical history of intermittent allergic rhinitis with seasonal onset and offset of nasal allergy symptoms during each of the last two ragweed allergy seasons
- •positive skin prick test to ragweed allergen within twelve months of screening
- •Exclusion criteria:
- •Use of any medication used to treat allergy (administered via any route), such as: pseudoephedrine, antihistamines, ipratropium bromide, cromoglycates, corticosteroids, immunotherapy or other antiinflammatory or immunosuppressive agents, or any other medication administered via the nasal or ocular routes)
- •Within the last three years a recurrent history of acute or chronic bronchospastic disease including moderate-severe asthma or chronic obstructive pulmonary disease
- •Nasal conditions such as nasal septal perforations,nasal polyps, sinus disease, chronic nasal obstruction
- •Other protocol-defined inclusion/exclusion criteria may apply
排除标准
- 未提供
研究组 & 干预措施
QAV680 Placebo + Cetirizine Placebo
Placebo Comparator
干预措施: QAV680 Placebo + Cetirizine Placebo (Drug)
QAV680 + Cetirizine Placebo
Active Comparator
干预措施: QAV680 + Cetirizine Placebo (Drug)
QAV680 + Cetirizine
Experimental
干预措施: QAV680 + Cetirizine (Drug)
Cetirizine + QAV680 Placebo
Active Comparator
干预措施: Cetirizine + QAV680 Placebo (Drug)
结局指标
主要结局
Total Nasal Symptom Score measured during allergen exposure
时间窗: 14 Days
次要结局
- Total Nasal Symptom Score & Total Ocular Symptom Score measured during allergen exposure(14 days)
- Nasal airway patency assessed by acoustic rhinometry during allergen exposure(14 days)
- Nasal secretion weight during allergen exposure(14 days)
研究者
研究点 (1)
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