NCT02295969已完成不适用
An Observational Study of ORALAIR® (Grass Pollen Allergen Extract From: Cocksfoot, Sweet Vernal, Rye Grass, Meadow Grass, Timothy) Tablet for Sublingual Use in Children 5 to 9 Years of Age With Grass-pollen-induced Allergic Rhinitis With or Without Conjunctivitis
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 307
- 试验地点
- 1
- 主要终点
- All adverse events that started on or after the day the first dose of Oralair
研究概览
简要总结
Safety and tolerability of ORALAIR in children 5 to 9 years of age during the first 30 days of treatment.
详细描述
The purpose of this study is to further describe the safety and tolerability of ORALAIR tablets in children 5 to 9 years of age with grass-pollen-induced allergic rhinitis with or without conjunctivitis.
Patients are followed for safety and tolerability during the first 30 treatment days.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Allergen immunotherapy naive male or female outpatients aged 5 to 9 years (inclusive) prescribed ORALAIR.
排除标准
- •Patients already participating in a clinical trial.
结局指标
主要结局
All adverse events that started on or after the day the first dose of Oralair
时间窗: During 30 days after the date of the first dose
次要结局
未报告次要终点
研究者
研究点 (1)
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