NCT00357279已完成3 期
A Multi-Center, Double-Blind, Placebo-Controlled Randomized, Efficacy and Safety Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease
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
- 352
- 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 a one dose strength of denufosol compared to placebo in patients with mild 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
- 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% of predicted normal for age, gender, and height
- •Be able to reproducibly perform spirometry maneuvers
- •Be clinically stable for at least 4 weeks prior to screening
排除标准
- •Have abnormal renal or liver function
- •Have chest x-ray at screening suggesting clinically significant active pulmonary disease
- •Be colonized with Burkholderia cepacia
- •Have had a lung transplant
研究组 & 干预措施
1
Placebo Comparator
Placebo
干预措施: Placebo - 0.9% w/v sodium chloride solution (Drug)
2
Experimental
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(48 weeks)
- Quality of Life(48 weeks)
- Requirements for concomitant CF medications(48 weeks)
研究者
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