NCT00521131已完成4 期
Evaluation of Efficacy, Using the Number of Comfortable Days and the Safety of Levocetirizine Dihydrochloride, Administered Once Daily in the Evening for 30 Days, to Subjects Suffering From Perennial Allergic Rhinitis to House Dust Mites
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 453
- 主要终点
- Number of comfortable days, as assessed by the subject
研究概览
简要总结
Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites
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
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female ≥ 12 years
- •suffering from a perennial allergic rhinitis to house dust mites for at least 2 years
- •positive skin test or positive Radio-Allergo-Sorbent-Test for house dust mites
- •the mean of the T4SS evaluated in the evening over the last 24 hours of the selection period was ≥ 5
排除标准
- •seasonal allergic rhinitis likely to change significantly the symptoms of the subject
- •an ear, nose or throat (ENT) infection during the two weeks preceding initial visit
- •asthma requiring corticosteroid treatment
- •atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids
- •associated ENT disease
结局指标
主要结局
Number of comfortable days, as assessed by the subject
时间窗: 30 days
次要结局
- Sum of 4 and 5 rhinitis symptoms and safety(Week 1 and over 30 days)
研究者
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