NCT00160680已完成4 期
A Pilot, Open, Monocenter, Randomized Two Parallel Groups, Clinical Efficacy Trial: Comparison Continuous Versus on Demand Regimen of Treatment With Levocetirizine 5 mg Oral Tablets, Once a Day, in Adults Suffering From Persistent Allergic Rhinitis (PER) Over 6 Months
UCB S.A. - Pharma Sector0 个研究点目标入组 62 人开始时间: 2005年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 主要终点
- Mean Weekly Total 4 Symptom Score (T4SS) During the Treatment Period
研究概览
简要总结
Comparison of clinical efficacy and safety of levocetirizine in PER continuous versus on demand, measured by evolution of individual symptom scores during 6 months.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical history of Persistent allergic Rhinitis (PER) requiring treatment known at least since 2 years.
- •Positive skin prick test (wheal > 3 mm larger than the diluent control) or Radio Allergo Sorbent Assay (RAST) (>= 3.5 IU/ml) to House Dust Mite (HDM) and Parietaria (less than 1 year).
- •Minimum mean Total 4 Symptom Score (T4SS) of 6 over baseline period.
排除标准
- •Subjects currently treated by specific parietaria pollen immunotherapy
- •Subjects suffering from non-allergic asthma
- •Chronic use of inhaled steroids and/or long acting β2 agonists; and/or corticosteroids dependent asthma (severe asthma)
- •Atopic dermatitis or urticaria requiring antihistamine treatment or the administration of oral or topical corticosteroids
研究组 & 干预措施
Continuous Treatment
Experimental
5 mg of Levocetirizine (LCTZ) was taken orally once a day.
干预措施: Levocetirizine (Drug)
On Demand Treatment
Experimental
5 mg of Levocetirizine (LCTZ) was taken whenever needed.
干预措施: Levocetirizine (Drug)
结局指标
主要结局
Mean Weekly Total 4 Symptom Score (T4SS) During the Treatment Period
时间窗: During the treatment period until week 24
The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease.
次要结局
- Mean Monthly Total 4 Symptom Score (T4SS) for Month 3 of the Treatment Period(During month 3 of the 6 months treatment period)
- Mean Monthly Total 4 Symptom Score (T4SS) for Month 6 of the Treatment Period(During month 6 of the 6 months treatment period)
- Mean Monthly Individual Symptoms Scores During Month 1 of the Treatment Period(During month 1 of the 6 months treatment period)
- Mean Monthly Total 4 Symptom Score (T4SS) for Month 1 of the Treatment Period(During month 1 of the 6 months treatment period)
- Mean Monthly Individual Symptoms Scores During Month 2 of the Treatment Period(During month 2 of the 6 months treatment period)
- Mean Monthly Total 4 Symptom Score (T4SS) for Month 2 of the Treatment Period(During month 2 of the 6 months treatment period)
- Mean Monthly Total 4 Symptom Score (T4SS) for Month 4 of the Treatment Period(During month 4 of the 6 months treatment period)
- Mean Monthly Total 4 Symptom Score (T4SS) for Month 5 of the Treatment Period(During month 5 of the 6 months treatment period)
- Mean Weekly Individual Symptoms Scores During the Treatment Period(During the treatment period until week 24)
- Mean Monthly Individual Symptoms Scores During Month 4 of the Treatment Period(During month 4 of the 6 months treatment period)
- Mean Monthly Individual Symptoms Scores During Month 3 of the Treatment Period(During month 3 of the 6 months treatment period)
- Mean Monthly Individual Symptoms Scores During Month 5 of the Treatment Period(During month 5 of the 6 months treatment period)
- Mean Monthly Individual Symptoms Scores During Month 6 of the Treatment Period(During month 6 of the 6 months treatment period)
研究者
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