NCT01051258已完成1 期
A Study of the AeriSeal System for Lung Volume Reduction in Patients With Advanced Emphysema
Aeris Therapeutics11 个研究点 分布在 4 个国家目标入组 55 人开始时间: 2009年11月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 11
- 主要终点
- Change from baseline in respiratory volume/total lung capacity (RV/TLC) ratio
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of AeriSeal treatment in patients with advanced emphysema.
详细描述
The purpose of this study is to evaluate the safety and efficacy of AeriSeal treatment in patients with advanced homogeneous and heterogeneous emphysema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have a diagnosis of advanced emphysema as defined by FEV1/FVC<70% predicted, FEV1 of <50% predicted, TLC > 100% predicted, and RV > 135% predicted.
- •Patients must have persistent symptoms despite medical therapy and either not be candidates for Lung Volume Reduction Surgery (LVRS) or have elected not to undergo LVRS.
- •Patients must be > 40 years of age, have symptoms despite medical therapy, and have none of the prespecified co-morbid conditions that could influence study outcomes or their ability to tolerate bronchoscopy.
排除标准
- 未提供
结局指标
主要结局
Change from baseline in respiratory volume/total lung capacity (RV/TLC) ratio
时间窗: 12 Weeks following final treatment
次要结局
- Change from baseline in RV/TLC ratio(24 and 48 weeks following treatment)
- Change from baseline in forced expiratory volume in 1 second (FEV1) (post bronchodilator)(12, 24, 48 weeks following treatment)
- Change from baseline in MRC dyspnea score(12, 24, 48 weeks following treatment)
- Change from baseline in 6 minute walk test (MWT)(12, 24, 48 weeks following treatment)
- Change from baseline in disease-specific health related quality of life assessment (SGRQ)(12, 24, 48 weeks following treatment)
研究者
研究点 (11)
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