NCT02238210已完成4 期
A Phase IV Safety Trial in Pediatric Patients (Ages 2-5) With Rhinorrhea Associated With a Common Cold or Allergy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 230
- 主要终点
- Number of patients with adverse events
研究概览
简要总结
Study to determine the safety of Atrovent Nasal Spray 0.06% in pediatric patients (ages 2-5 years) with symptoms of rhinorrhea associated with a naturally occurring common cold or from symptoms of rhinorrhea associated with allergies
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Atrovent® - common cold group
Experimental
Treatment duration for common cold group - three time daily for 4 days
干预措施: Atrovent® (Drug)
Experimental: Atrovent® - allergy group
Experimental
Treatment duration for allergy group - three time daily for 14 days
干预措施: Atrovent® (Drug)
结局指标
主要结局
Number of patients with adverse events
时间窗: up to 21 days
Patient's parent/legal guardian global assessment - allergy group
时间窗: Day 14
Patient's parent/legal guardian global assessment - common cold group
时间窗: Day 4
次要结局
- Patient's parent/legal guardian daily assessment of nasal congestion (stuffy nose) rated on 5-point scale - allergy group(Day 14)
- Patient's parent/legal guardian daily assessment of nasal congestion (stuffy nose) rated on 5-point scale - common cold group(Day 4)
- Patient's parent/legal guardian daily assessment of sneezing rated on 5-point scale - common cold group(Day 4)
- Patient's parent/legal guardian daily assessment of rhinorrhea (runny nose) rated on 5-point scale - allergy group(Day 14)
- Patient's parent/legal guardian daily assessment of rhinorrhea (runny nose) rated on 5-point scale - common cold group(Day 4)
- Number of patients with clinically findings in nasal and otoscopic examination - common cold group(up to day 4)
- Patient's parent/legal guardian daily assessment of sneezing rated on 5-point scale - allergy group(Day 14)
- Number of patients with clinically findings in nasal and otoscopic examination - allergy group(up to day 14)
研究者
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