NCT00524836已完成3 期
A Study Evaluating the Efficacy and Safety of 5 mg Levocetirizine Oral Tablets, Once Daily Versus 10 mg Loratadine Oral Tablets, Once Daily for the Treatment of Perennial Allergic Rhinitis.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 71
- 主要终点
- Total 5 Symptom Score (T5SS) rated by the investigator
研究概览
简要总结
Efficacy and Safety of Levocetirizine Versus Loratadine for the Treatment of Perennial Allergic Rhinitis.
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
- Single
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male ore female, 16 to 60 years old (inclusive)
- •two-year history of allergic rhinitis due to house dust mite
排除标准
- •An ear, nose or throat (ENT) infection
- •asthma requiring daily drug therapy other than ß2 inhaled agonists taken prn
- •atopic dermatitis or urticaria requiring an antihistamine or corticosteroid treatment
- •an associated ENT disease
- •use of decongestants
- •nasal or ocular topical treatment
- •desensitivation
结局指标
主要结局
Total 5 Symptom Score (T5SS) rated by the investigator
时间窗: 2 weeks
次要结局
- Investigators global efficacy evaluation at the end of treatment; subject's rating of T5SS and individual symptoms (over the last 24 hours) over first week and the total 2 weeks treatment period; the Symptoms Score Reducing Index (SSRI).(2 weeks)
研究者
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