NCT00425165终止2 期
A Randomized, Double-Blind, Two Way Crossover Evaluation of the Effects of a Single Dose of Denufosol Tetrasodium (INS37217) Inhalation Solution Versus Placebo (0.9% Sodium Chloride Solution) on Mucociliary Clearance in Patients With Mild to Moderate Cystic Fibrosis Lung Disease
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 主要终点
- Change in mucociliary clearance from baseline
研究概览
简要总结
The purpose of this trial is to evaluate the effects of a single dose of denufosol versus placebo on mucociliary clearance in patients with mild to moderate CF lung disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 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 60% 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 with abnormalities suggesting clinically significant active pulmonary disease
- •have had a lung transplant
结局指标
主要结局
Change in mucociliary clearance from baseline
时间窗: 30, 60, and 90 minutes post aerosol inhalation
次要结局
未报告次要终点
研究者
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