NCT00384475已完成3 期
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study Using the Environmental Exposure Chamber (EEC) to Assess the Onset of Action of Ciclesonide, Applied as a Nasal Spray (200 mcg, Once Daily), in the Treatment of Seasonal Allergic Rhinitis (SAR) in Patients 18 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
- 500
- 试验地点
- 2
- 主要终点
- Onset of action, measured by change from baseline in Total Nasal Symptom Score.
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 seasonal allergic rhinitis caused by pollen. Ciclesonide will be administered once during the exposure to ragweed pollen in a controlled environment. The study duration consists of a baseline period (up to 5 days) and a treatment period (1 day). The study will provide further data on safety and tolerability of ciclesonide.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •General good health
- •History of SAR to short ragweed pollen for 2 years immediately preceding the study
- •Demonstrated sensitivity to short ragweed known to induce SAR through a standard skin prick test
排除标准
- •Clinically significant physical finding of nasal anatomical deformities causing greater than 50% obstruction, including but not limited to nasal polyps, septal defects, respiratory tract malformations, nasal trauma or surgery
- •Known hypersensitivity to any corticosteroid
- •History of a respiratory infection or disorder including but not limited to bronchitis, pneumonia, chronic sinusitis, influenza or SARS (severe acute respiratory syndrome) within 14 days preceding the Screening Visit
- •History of alcohol or drug abuse within 2 years preceding the Screening Visit
- •Active asthma requiring treatment of inhaled or systemic corticosteroids and/or routine use of beta-agonists or any controller drugs
- •Use of antibiotic therapy for acute conditions within 14 days preceding the Screening Visit
- •Exposure to systemic corticosteroids for any indication, chronic or intermittent within 60 days preceding the Screening Visit
结局指标
主要结局
Onset of action, measured by change from baseline in Total Nasal Symptom Score.
次要结局
- changes in symptoms, safety.
研究者
研究点 (2)
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