NCT00103714已完成2 期
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in 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
- 72
- 主要终点
- respiratory function
研究概览
简要总结
The objectives of this study are to evaluate the safety, tolerability and preliminary efficacy of two dose levels of INS37217 (denufosol tetrasodium) Inhalation Solution in patients with cystic fibrosis (CF) lung disease.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 8 Years 至 50 Years（Child, Adult）
- 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% or less than or equal to 90% of predicted normal
- •Have oxygen saturation greater than or equal to 90% on room air
- •Be clinically stable with no evidence of acute upper or lower respiratory tract infection or current pulmonary exacerbation
- •Be able to reproducibly perform spirometry maneuvers
排除标准
- •Have changed their physiotherapy technique or schedule within 7 days prior to screening
- •Have clinically significant comorbidities
- •Using prior and concurrent medications according to the protocol
结局指标
主要结局
respiratory function
次要结局
- adverse events
- change in standard safety parameters
- respiratory symptoms via questionnaire
- pulmonary exacerbation
研究者
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