NCT01181622已完成2 期
A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 7-Day Safety and Tolerability Study of Denufosol Tetrasodium Inhalation Solution Administered Via PARI LC® Star in Patients 2 to 4 Years of Age With Cystic Fibrosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- Intolerability to study drug as measured by: oxyhemoglobin saturation, treatment-emergent cough, and new wheezes or crackles
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of denufosol 60 mg TID in pediatric CF patients 2 to 4 years of age
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
- 2 Years 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a confirmed diagnosis of CF
- •Have oxyhemoglobin saturation ≥ 95% prior to randomization
排除标准
- •Have acute intercurrent respiratory infection (cough, wheezing, or new
- •rhinorrhea or nasal congestion)
- •Have any significant medical condition not related to CF
- •Unable to discontinue use of hypertonic saline
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: 0.9% w/v sodium chloride solution (Drug)
denufosol tetrasodium Inhalation Solution
Experimental
干预措施: denufosol tetrasodium Inhalation Solution (Drug)
结局指标
主要结局
Intolerability to study drug as measured by: oxyhemoglobin saturation, treatment-emergent cough, and new wheezes or crackles
时间窗: Day 1, Day 7
次要结局
- Mean change from baseline in pulse and respiratory rate(Day 7)
- Incidence of new medical condition(s) or worsening of previous medical condition(s) from baseline(Day 7)
- Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and/or withdrawals due to TEAEs(Day 7)
- Mean change from pre-dose in pulse and respiratory rate at defined times post-dose(Day 1, Day 7)
- Mean change from pre-dose in oxyhemoglobin saturation at defined times post-dose(Day 1, Day 7)
- Mean change from baseline in oxyhemoglobin saturation(Day 7)
研究者
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