NCT00542607已完成4 期
Trial to Compare the Efficacy and Safety of Levocetirizine 5 mg od and Fexofenadine 120 mg od in Reducing Symptoms of Seasonal Allergic Rhinitis in Grass Pollen Sensitized Adults
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
- 94
- 主要终点
- Change from baseline of the mean Major symptom complex score over the last 2 hours of a 24-hour coverage
研究概览
简要总结
No information was yet available over the effect of levocetirizine in children under 12 years. The aim of this double-blind, placebo-controlled study was to assess the efficacy and safety of levocetirizine in children from 6 to 12 years old with perennial allergic rhinitis due to house dust mites.
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
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults 18 to 55 years both inclusive
- •suffering at least 2 years of seasonal allergic rhinitis due to grass pollen
- •positive RAST and/or positive skin prick test
- •comply with study restrictions
排除标准
- •known alcohol or drug addiction or abuse
- •known allergy/intolerance to lactose, cellulose, cornstarch
- •presence of nasal anatomical deformities leading to > 50% obstruction
- •ENT infection within 30 days of the study
- •use of disallowed medication
- •ongoing desensitization
- •known cardiac, renal or hepatic dysfunction
- •presenting allergic bronchial asthma
- •use of cimetidine
- •intending to donate blood during the trial
结局指标
主要结局
Change from baseline of the mean Major symptom complex score over the last 2 hours of a 24-hour coverage
次要结局
- The change from baseline of the mean MSC score over time interval 3
- the change from baseline of the mean MSC score over time intervals 1 and 4.
研究者
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