NCT01076491已完成1 期
A Pilot Study to Investigate the Feasibility and Tolerability of Inhaling a High Dose of Dry Powder Mannitol (IDPM) Per Breath Administered Via a Dry Powder Inhaler Loaded With a Single Capsule in Subjects With Bronchiectasis
Syntara2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2009年1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
- 10
- 试验地点
- 2
- 主要终点
- emitted dose
研究概览
简要总结
This study is to investigate the safety and tolerability of high doses of inhaled mannitol in subjects with bronchiectasis to further direct development of an improved drug delivery system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult subjects with non-CF bronchiectasis
- •FEV1 > 50 % predicted and > 1.0L
排除标准
- •bronchiectasis due to CF or endobronchial lesion
- •respiratory infection requiring IV antibiotics in last 4 weeks
- •pregnancy
- •significant haemoptysis in last 6 months
- •active TB
- •end stage ILD
- •contraindications as determined by investigator
结局指标
主要结局
emitted dose
时间窗: single measure
次要结局
未报告次要终点
研究者
研究点 (2)
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