Multicenter Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation in Subjects With Non-Cystic Fibrosis Bronchiectasis (NCFB) or Chronic Obstructive Pulmonary Disease (COPD) Using Matching Placebo
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 46
- 主要终点
- The user performed the inhalation task safely (Yes/No).
研究概览
简要总结
The rationale of this study is to conduct a summative (i.e., validation) usability test of Ciprofloxacin Dry Powder for Inhalation (DPI) and the associated Instructions for Use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 未提供
排除标准
- •Subjects with recent exacerbation
- •Subjects with recent significant hemoptysis in the four weeks before screening (and/or during the screening period)
- •Subjects allergic to quinine
- •Known chronic bronchial asthma
研究组 & 干预措施
Placebo to Ciprofloxacin DPI
Placebo to Ciprofloxacin DPI, 3 doses during test session, 1 additional dose for patients during device training
干预措施: Placebo to Ciprofloxacin DPI (BAYQ3939) (Drug)
结局指标
主要结局
The user performed the inhalation task safely (Yes/No).
时间窗: 1 Day
The user safety was assessed by a test administrator.
DPI (Dry powder for inhalation) device malfunction (Yes/No).
时间窗: 1 Day
The function was assessed by a test administrator.
The user performed the inhalation task based on the given instructions properly (Yes/No).
时间窗: 1 Day
The performance was assessed by a test administrator.
Subject's subjective feedback (paraphrased) on use-safety and usability
时间窗: 1 Day
次要结局
- User friendliness(1 Day)
- Inhalation time(1 Day)