NCT00641212已完成4 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Effect of Long-Term Treatment With Rhinocort Aqua (Budesonide) Nasal Spray in Children With Perennial Allergic Rhinitis.
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
- AstraZeneca
- 入组人数
- 209
- 主要终点
- Change in height over a 12 month period
研究概览
简要总结
The purpose of this study is to compare the effect of Rhinocort nasal spray with placebo on growth in children with perennial allergic rhinitis over 12 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
- Double
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In the opinion of the investigator, is a candidate for treatment with nasal steroids based on a history of either a) inadequate control of symptoms with antihistamines, decongestants and/or immunotherapy, or b) prior successful treatment with nasal steroids.
- •A documented history of at least one year of perennial allergic rhinitis.
- •A positive response to a skin prick test for perennial allergens that must be present in the subject's environment.
- •Height and weight within normal limits.
排除标准
- •Any disease which may affect growth
- •Sexual development later than Tanner stage I.
- •Nasal candidiasis, rhinitis medicamentosa, acute or chronic sinusitis, influenza, upper respiratory tract infection or structural abnormalities of the nose (e.g., septal deviation, nasal polyps) symptomatic enough to cause significant nasal obstruction as judged by the investigator.
研究组 & 干预措施
1
Experimental
Budesonide
干预措施: Budesonide (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in height over a 12 month period
时间窗: 3 monthly
次要结局
- Change in growth velocity over a 12 month period.(3 monthly)
- Other safety - assessed by adverse event query(3 monthly)
研究者
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