Assessment of Bronchodilator Responsiveness in Healthy Young Adults Using Forced Oscillations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Bronchodilation responses, assessed by both spirometry and FOT, in healthy young subjects after receiving salbutamol or placebo
研究概览
简要总结
Studies evaluating response to bronchodilation in flow-volume spirometry and/or by forced oscillations technique (FOT), have been conduced in subjects with obstructive airways diseases. Less is known about bronchodilation responses, assessed by both spirometry and FOT in healthy young subjects.
The purpose of the present study is
- to determine the range of the bronchodilation response in terms of changes in selected spirometric parameters in healthy non-smoking young adults, for identifying normal response after an inhaled bronchodilatory agent versus placebo, and its anthropometric and spirometric determinants
- to determine the range and characteristics of bronchodilation response using pseudorandom FOT in healthy non-smoking young adults, for identifying normal response after an inhaled bronchodilatory agent versus placebo, and its anthropometric and oscillometric determinants.
- to compare and correlate eventual changes in spirometric and oscillometric parameters.
The investigators hypothesize that exists a normal variation in spirometric and oscillometric parameters after bronchodilation, and that these parameters are correlated.
详细描述
INTRODUCTION
Studies evaluating response to bronchodilation in flow-volume spirometry and/or by forced oscillations technique (FOT), have been conduced in subjects (children or adults) with obstructive airways diseases. Less is known about bronchodilation responses, assessed by both spirometry and FOT in healthy young subjects.
PURPOSE
The purpose of the present study is
- to determine the range of the bronchodilation response in terms of changes in PEF, FEV1, FEF25, FEF50, FEF75, and FEF25-75, in healthy non-smoking young adults, for identifying normal response after an inhaled bronchodilatory agent versus placebo, and its anthropometric and spirometric determinants
- to determine the range and characteristics of bronchodilation response using pseudorandom FOT in healthy non-smoking young adults, for identifying normal response after an inhaled bronchodilatory agent versus placebo, and its anthropometric and oscillometric determinants.
- to compare and correlate eventual changes in spirometric and oscillometric parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy non-smoking young adults
排除标准
- •Respiratory symptoms
- •Respiratory disease
- •Respiratory medication
结局指标
主要结局
Bronchodilation responses, assessed by both spirometry and FOT, in healthy young subjects after receiving salbutamol or placebo
时间窗: 15 minutes after inhalation of salbutamol or placebo
次要结局
未报告次要终点