NCT01424137已完成不适用
Inspiratory Flow Parameters With Placebo Dry Powder Inhalers, Easyhaler and Diskus; an Open, Randomised, Multicentre Study in Patients With Asthma or COPD
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 227
- 试验地点
- 5
- 主要终点
- Peak inspiratory flow rate through the placebo Easyhaler and Diskus inhalers
研究概览
简要总结
The purpose of this study is to characterise inspiratory flow parameters across 2 Easyhaler® (EH) inhaler versions and Diskus® inhaler in patients with asthma (including children, adults, and the elderly) and in patients with chronic obstructive pulmonary disease (COPD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent (IC) obtained
- •Documented diagnosis of asthma and/or COPD
- •Age: 4 years and above
排除标准
- •Any severe chronic respiratory disease other than asthma or COPD
- •Acute respiratory infection
- •Any medical condition that in the opinion of the investigator would endanger the subject if he/she participates in the study
研究组 & 干预措施
Easyhaler type A
Other
干预措施: Easyhaler type A (Device)
Easyhaler type B
Other
干预措施: Easyhaler type B (Device)
Diskus inhaler
Other
干预措施: Diskus inhaler (Device)
结局指标
主要结局
Peak inspiratory flow rate through the placebo Easyhaler and Diskus inhalers
时间窗: 1 day
次要结局
- The inspiratory volume through the placebo Easyhaler and Diskus inhalers will be measured at the same time with the peak inspiratory flow rate(1 day)
研究者
研究点 (5)
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