NCT00984906已完成不适用
Inspiratory Flow Parameters and Device Handling With Empty Device-metered Dry Powder Inhalers, Easyhaler and Turbuhaler; an Open, Randomised, Multi Centre 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
- 200
- 试验地点
- 4
- 主要终点
- Peak inspiratory flow rate through the empty Easyhaler and Turbohaler inhalers
研究概览
简要总结
The aim of the study is to measure the inspiratory flow that the different patient groups (asthmatic children, adults and elderly, as well as chronic obstructive pulmonary disease (COPD) patients) generate through empty Easyhaler (two versions) and Turbuhaler inhalers. In addition, the handling and acceptability of the inhalers will be compared in asthmatic children.
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained.
- •Documented diagnosis of asthma and/or COPD (a range of different severities for both diseases).
- •Age: 6 years or above.
排除标准
- •Any severe chronic respiratory disease other than asthma or COPD.
- •Acute respiratory infection.
- •Concurrent participation in a clinical drug study.
- •Inability to perform repeatable spirometric measurements.
- •Any medical condition that in the opinion of the investigator would endanger the subject if he/she participates in the study (such as contraindications to spirometry).
研究组 & 干预措施
Empty Easyhaler type A
Other
干预措施: Empty inhalers (Other)
Empty Easyhaler type B
Other
干预措施: Empty inhalers (Other)
Empty Turbohaler
Other
干预措施: Empty inhalers (Other)
结局指标
主要结局
Peak inspiratory flow rate through the empty Easyhaler and Turbohaler inhalers
时间窗: 1 Day
次要结局
- Other inspiratory flow parameters through the empty Easyhaler and Turbohaler inhalers measured at the same time with the peak inspiratory flow rate.(1 Day)
- Acceptability of the inhalers in the subpopulation of asthmatic children(1 Day)
- Handling of the devices in the subpopulation of asthmatic children(1 Day)
研究者
研究点 (4)
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