NCT00257595已完成3 期
Long-term Study of Cetirizine Dry Syrup in Children. Suffering From Perennial Allergic Rhinitis.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- safety
研究概览
简要总结
To assess the safety of long-term use of cetirizine dry syrup in children with perennial allergic rhinitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with perennial allergic rhinitis.
- •Giving informed consent.
- •Children with a positive response to specific IgE antibody test.
- •Children assessed as positive in the nasal eosinophil count.
- •Children whose severity score of nasal symptom is 4 or higher.
排除标准
- •have a history of drug hypersensitivity.
- •are pregnant, lactating or possibly pregnant female children.
- •Sensitivity to pollen as a duplicate allergen and whose treatment periods are thought in the pollen dispersion periods.
- •have vasomotor rhinitis and eosinophilic rhinitis.
- •have asthma that requires the treatment with corticosteroid.
- •have inappropriate complication of nasal disorder that may influence on the evaluation of the study drugs.
- •have complicated with atopic dermatitis or urticaria that requires the treatment with antihistamine preparation.
- •have started specific desensitization treatment.
- •nonspecific modulation treatment but who have not reached the maintenance level of treatment.
- •have received surgical treatment for reduction and modulation of nasal mucosa.
- •redintegration therapy of nasal cavity to improve the degree of nasal airway.
- •surgical operation to improve rhinorrhea.
结局指标
主要结局
safety
次要结局
- Total Nasal Symptom Score (TNSS) Individual nasal symptom score total score of 4 individual daily symptom scores Investigator global improvement rating
研究者
研究点 (1)
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