NCT00846781终止3 期
Study 08-114 Open-label Extension of Study 08-110 - A Multi-Center Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis Lung Disease (P08642)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 308
- 主要终点
- Rate of change in lung function, as measured by change in FEV1
研究概览
简要总结
The purpose of this study is to obtain data on the potential of long-term treatment with denufosol to improve the clinical course of CF lung disease in patients with mildly impaired lung function and to provide CF patients who completed study 08-110 continued access to denufosol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Completed Study 08-110
排除标准
- •A female patient will not be eligible for the study if she is of childbearing potential and is pregnant, lactating, and/or not practicing an acceptable method of birth control (e.g., abstinence, hormonal or barrier methods, partner sterilization, or intrauterine device).
- •Have a condition that might affect compliance with study procedures
研究组 & 干预措施
Denufosol tetrasodium Inhalation Solution
Experimental
干预措施: Denufosol tetrasodium Inhalation Solution (Drug)
结局指标
主要结局
Rate of change in lung function, as measured by change in FEV1
时间窗: 160 Weeks
次要结局
- Change in absolute FEV1 from baseline(Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160)
- Change in FEV1 percent predicted value from baseline(Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160)
- Change in FEF25%-75% and forced vital capacity (FVC) from baseline(Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160)
- Incidence of pulmonary exacerbations(160 Weeks)
- Changes in Pseudomonas aeruginosa status(160 Weeks)
- Number of days of intravenous (IV) antibiotic use for a respiratory complaint(160 Weeks)
- Incidence of hospitalizations/Emergency room (ER) visits for a respiratory complaint(160 Weeks)
- Number of days hospitalized for a respiratory complaint(160 Weeks)
- Incidence of hospitalizations/ER visits(160 Weeks)
- Incidence of treatment emergent adverse events (AEs), serious adverse events (SAEs) and withdrawals due to AEs(160 Weeks)
- Incidence of patients with significant decrease in absolute FEV1 at any visit from baseline(160 Weeks)
- Changes in physical exam findings including height, weight, and body mass index from baseline(Weeks 48, 96, and 160)
- Changes in hematology, serum chemistry, and urinalysis parameters from baseline(Weeks 24, 48, 72, 96, 120, 144, and 160)
- Incidence of early discontinuations from the study(160 Weeks)
研究者
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