NCT00261287已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial Designed to Assess the Safety and Tolerability of Ciclesonide (200 mcg Once Daily), Applied as a Nasal Spray for Twelve Weeks, in the Treatment of Perennial Allergic Rhinitis (PAR) in Pediatric Patients 2-5 Years of Age
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 102
- 试验地点
- 4
- 主要终点
- Safety and tolerability of ciclesonide nasal spray
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of ciclesonide nasal spray for long term use in relieving symptoms in 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
- Double
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •General good health, other than perennial allergic rhinitis
- •History and diagnosis of perennial allergic rhinitis by skin prick test
- •History of perennial allergic rhinitis for a minimum of 90 days immediately before the screening visit
排除标准
- •Participation in any investigational drug trial within the 30 days before the screening visit
- •Use of any disallowed concomitant medications within the prescribed withdrawal periods before the screening visit
- •A known hypersensitivity to any corticosteroid
结局指标
主要结局
Safety and tolerability of ciclesonide nasal spray
次要结局
未报告次要终点
研究者
研究点 (4)
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