NCT00521040已完成不适用
Evaluation of the Efficacy and Safety of Levocetirizine During 8 Weeks Preceding and Following the Anticipated Onset of the Grass Pollen Season in Subjects Suffering From Seasonal Allergic Rhinitis Associated With Pollen-induced Asthma
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 459
- 主要终点
- T4SS (sum of the scores of the severity of sneezing, rhinorrhea, nasal pruritus and ocular pruritus)
研究概览
简要总结
Efficacy and Safety of Levocetirizine 8 Weeks Prior and After the Onset of the Grass Pollen Season in Subjects With SAR
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 subjects ≥ 12 years
- •2 year history of seasonal allergic rhinitis
- •documented hypersensitivity to local seasonal allergens (grass pollen)
- •documented pollen-induced asthma
- •without acute ongoing exacerbation of asthma or allergic rhinitis
- •no continuous ongoing treatment for rhinitis or asthma
排除标准
- •non-allergic rhinitis and anatomic abnormalities disturbing the analysis of nasal capacity
- •symptomatic rhinitis or asthma due to tree pollens
- •currently treated by specific grass pollen immunotherapy
- •suffering from non-allergic asthma
- •chronic use of inhaled steroids and/or long acting β2 agonists; and/or corticosteroid dependent asthma
- •atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids
- •contraindication for salbutamol use
结局指标
主要结局
T4SS (sum of the scores of the severity of sneezing, rhinorrhea, nasal pruritus and ocular pruritus)
时间窗: 12 weeks
次要结局
- Pollen-induced symptomatology of asthma; symptoms of rhinitis and asthma over the first 4 season weeks and during the entire observation period following the actual onset of the grass pollen season(12 weeks)
研究者
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