NCT00163501已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Trial to Assess the Long Term Safety of Ciclesonide, Applied as a Nasal Spray (200 Mcg, Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Patients 12 Years and Older
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
- 600
- 试验地点
- 42
- 主要终点
- change in Total Nasal Symptom Scores.
研究概览
简要总结
The purpose of this study is to investigate the safety and effectiveness of ciclesonide nasal spray as compared with placebo (inactive substance) nasal spray in relieving symptoms of 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
- Double
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General good health, other than perennial allergic rhinitis
- •History and diagnosis of perennial allergic rhinitis by skin prick test
排除标准
- •Participation in any investigational drug trial within the 30 days preceding the Screening Visit
- •A known hypersensitivity to any corticosteroid or any of the excipients in the formulation
- •Use of any prohibited concomitant medications as defined by the study protocol
结局指标
主要结局
change in Total Nasal Symptom Scores.
次要结局
- change in symptoms, quality of life, safety.
研究者
研究点 (42)
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