NCT00779077已完成不适用
An Open, Observational, Non-Interventional Study of Inspiratory Flow Rates and Volumes in Subjects With Cystic Fibrosis Inhaling Via a Spirometer With the High Resistance RS01 Dry Powder Inhaler Device in Series
Syntara0 个研究点目标入组 25 人开始时间: 2009年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 主要终点
- inspiratory flow rates
研究概览
简要总结
We wish to measure the inspiratory flow and volumes generated by the subjects inhaling from a spirometer with a high resistance dry powder inhaler in series in subjects with cystic fibrosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 年龄范围
- 6 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •FEV1 ≥ 30% and < 90% predicted
排除标准
- •Be considered "terminally ill" or listed for lung transplantation
- •Have had a lung transplant
- •Have had a significant episode of haemoptysis (>60 ml) in the three months prior to enrolment
- •Have had a myocardial infarction in the three months prior to enrolment
- •Have had a cerebral vascular accident in the three months prior to enrolment
- •Have had major ocular surgery in the three months prior to enrolment
- •Have had major abdominal, chest or brain surgery in the three months prior to enrolment
- •Have a known cerebral, aortic or abdominal aneurysm
- •Be breast feeding or pregnant
- •Be using beta blockers
- •Have unstable asthma
结局指标
主要结局
inspiratory flow rates
时间窗: single visit
次要结局
- inspiratory volumes(single visit)
研究者
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