NCT00056147已完成2 期
Multi-Center, Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of INS37217 Inhalation Solution in Subjects 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
- 已完成
- 入组人数
- 90
- 主要终点
- respiratory symptoms
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of multiple dosages of INS37217 compared to placebo over 28 days in subjects with mild to moderate cystic fibrosis (CF) lung disease. Study drug will be administered through a nebulizer (a device that delivers medication as a mist by breathing it in).
详细描述
The purpose of this study is to:
- assess the safety and efficacy of multiple dose levels of INS37217 compared to placebo over 28 days in subjects with mild to moderate CF lung disease;
- explore evidence of activity of INS37217 and placebo administered via PARI LC STAR nebulizer;
- identify dose(s) that will be studied in subsequent trials.
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
- 8 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed diagnosis of CF
- •FEV1 greater than or equal to 75% of predicted normal for age, gender, and height
- •oxyhemoglobin saturation greater than or equal to 90%
- •clinically stable
排除标准
- •abnormal renal or liver function
- •clinically significant findings atypical for moderate cystic fibrosis
结局指标
主要结局
respiratory symptoms
lung function
measures of lung characteristics
sputum weight
pulmonary exacerbations
次要结局
- safety measures
研究者
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