NCT00130182已完成2 期
A Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Pediatric Patients With Cystic Fibrosis Lung Disease
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 6
- 主要终点
- respiratory function
研究概览
简要总结
The purpose of this study is to investigate the safety and effectiveness of two dose strengths of study drug compared to placebo in pediatric patients with cystic fibrosis (CF).
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
- 5 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have confirmed diagnosis of CF
- •Have an FEV1 greater than or equal to 60%
- •Have oxygen saturation greater than or equal to 90% on room air
- •Be clinically stable for at least 4 weeks prior to screening
- •Be able to reproducibly perform spirometry maneuvers
排除标准
- •Have clinically significant comorbidities
- •Have changed their physiotherapy technique or schedule within 7 days prior to screening
- •Using prior and concurrent medications according to protocol
结局指标
主要结局
respiratory function
次要结局
- adverse events
- change in standard safety parameters
- pulmonary exacerbation
研究者
研究点 (6)
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