NCT00163514已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Trial Designed to Assess the Efficacy and Safety of Ciclesonide Applied as a Nasal Spray at Three Dose Levels (200 Mcg, 100 Mcg, or 25 Mcg, Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Patients 6-11 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
- 636
- 试验地点
- 75
- 主要终点
- changes 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 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
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 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
- •Parent/caregiver must be capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent and comply with all study requirements (visits, record-keeping, etc.)
排除标准
- •Participation in any investigational drug trial within the 30 days preceding the Screening Visit or at any time during the trial
- •Use of any prohibited concomitant medications as defined by the study protocol
- •Non-vaccinated exposure to, or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit
结局指标
主要结局
changes in Total Nasal Symptom Score
次要结局
- safety, changes in symptoms
研究者
研究点 (75)
Loading locations...
相似试验
已完成
3 期
Safety and Effectiveness of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis During One Year Treatment (BY9010/M1-404)Hay FeverAllergic RhinitisPerennial Allergic RhinitisNCT00163501AstraZeneca600
已完成
3 期
A Study of Ciclesonide Nasal Spray in Patients 18 Years and Older With Seasonal Allergic Rhinitis (BY9010/M1-413)Rhinitis, Allergic, SeasonalHay FeverNCT00384475AstraZeneca500
已完成
3 期
Safety and Tolerability of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis (2-5 Years Old) (BY9010/M1-416)Hay FeverPerennial Allergic RhinitisNCT00261287AstraZeneca102
已完成
3 期
To Assess the Safety and Efficacy of Ciclesonide, Applied as a Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (BY9010/M1-401)Rhinitis, Allergic, SeasonalHay FeverNCT00659841AstraZeneca302
已完成
3 期
To Assess the Safety and Efficacy of Ciclesonide Applied as a Nasal Spray in the Treatment of Perennial Allergic Rhinitis (BY9010/M1-402)Rhinitis, Allergic, PerennialNCT00659750AstraZeneca418