NCT00625612已完成3 期
A Phase 3, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis Lung Disease and FEV1 Greater Than or Equal to 75% Predicted But Less Than or Equal to 110% Predicted
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 466
- 试验地点
- 104
- 主要终点
- Change in lung function
研究概览
简要总结
The purpose of this trial is to evaluate the safety and effectiveness of one dose strength of Denufosol compared to placebo in patients with CF and a predicted FEV1 of greater than or equal to 75% but less than or equal to 110% predicted.
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
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have confirmed diagnosis of cystic fibrosis
- •Have FEV1 of greater than or equal to 75% but less than or equal to 110%predicted normal for age, gender and height
- •Be able to reproducibly perform spirometry
- •Be clinically stable for at least 4 weeks before screening
排除标准
- •Have abnormal renal or liver function
- •Have lung transplant
- •Unable to discontinue use of hypertonic saline
- •Participated in Inspire trial 08-108
研究组 & 干预措施
2
Placebo Comparator
干预措施: Placebo (Drug)
1
Experimental
Denufosol Tetrasodium (INS37217) Inhalation Solution
干预措施: Denufosol Tetrasodium (INS37217) Inhalation Solution (Drug)
结局指标
主要结局
Change in lung function
时间窗: 48 weeks
次要结局
- Pulmonary Exacerbation, Antibiotic Use, Incidence of Hospitalization/ER visits, Health resource utilization, Quality of Life(48 weeks)
研究者
研究点 (104)
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