NCT00043316已完成1 期
A Phase I/II Study of Interferon Gamma-1b by Inhalation for the Treatment of Patients With Cystic Fibrosis
InterMune17 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2001年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 17
- 主要终点
- change in FEV1, sputum bacterial density
研究概览
简要总结
The purpose of this research study is to evaluate the safety and effectiveness of Interferon gamma-1b (IFN-g 1b) on lung function when given to patients with cystic fibrosis by inhalation (breathed into the lungs) three times a week for 12 weeks.
The FDA has not approved Interferon gamma-1b for use with cystic fibrosis patients, which is the condition being examined in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 12 years of age
- •Diagnosis of cystic fibrosis with mild to moderate pulmonary impairment
- •Must be receiving ongoing chronic treatment with TOBI (inhaled tobramycin) OR not receiving ongoing chronic treatment with TOBI and no use of TOBI or other inhaled antibiotic within 4 weeks prior to study drug administration·
- •Other specific diagnostic indicators of CF and other factors must meet minimum requirements.
排除标准
- 未提供
结局指标
主要结局
change in FEV1, sputum bacterial density
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
研究点 (17)
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