NCT03229252已完成2 期
A Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis (HOPE-1 Study: Hydration for Optimal Pulmonary Effectiveness)
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
- 91
- 试验地点
- 25
- 主要终点
- Change in Percent Predicted FEV1
研究概览
简要总结
28-Day double-blinded efficacy and safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-Blind
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of cystic fibrosis
- •ppFEV1 (percent predicted FEV1) between 50.0% and 80.0%
- •Stable CF Lung Disease
- •Males and non-pregnant, non-lactating females
排除标准
- •Significant unstable co-morbidities within 28 days of screening
- •Has received an investigational drug within 28 days of screening
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo Inhalation solution twice daily for 28 days.
干预措施: Placebo Inhalation Solution (Drug)
SPX-101 Low Dose
Experimental
Inhalation solution twice daily for 28 days.
干预措施: SPX-101 (Drug)
SPX-101 High Dose
Experimental
Inhalation solution twice daily for 28 days.
干预措施: SPX-101 (Drug)
结局指标
主要结局
Change in Percent Predicted FEV1
时间窗: Baseline and Day 28
次要结局
- Change From Baseline Through Day 28 in Clinical Laboratory Tests(Day 1 through Day 28)
- Number of Participants With Adverse Events(Day 1 through Day 28)
研究者
研究点 (25)
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