Salbutamol: Tolerance to Bronchoprotection vs. Methacholine: Time Course of Onset
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Airway responsiveness as a measure of salbutamol bronchoprotection
研究概览
简要总结
Overuse of inhaled bronchodilator beta agonist medication results in a loss of effectiveness (i.e. tolerance). This has been shown for the short acting beta agonist salbutamol and the long acting beta agonist salmeterol. Tolerance to salmeterol is present within 24 hours. The onset of tolerance to salbutamol is not known.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female
- •18 to 65 years of age
- •non smoker
- •beta agonist naive for at least 14 days
- •baseline FEV1 at least 70% predicted
- •no respiratory tract infection or allergen exposure (if atopic) within 4 weeks of visit 1
排除标准
- •poorly controlled asthma
- •pregnant or lactating women
研究组 & 干预措施
salbutamol
干预措施: salbutamol (Drug)
placebo
200mcg twice daily for a total of 7 doses
干预措施: Placebo (Drug)
结局指标
主要结局
Airway responsiveness as a measure of salbutamol bronchoprotection
时间窗: ten minutes post 200mcg salbutamol on day 7
Regular use of salbutamol results in loss of bronchoprotection. The primary outcome is to determine the onset of this tolerance.
Airway responsiveness as a measure of bronchoprotection. The primary outcome is to determine the onset of this tolerance.
时间窗: ten minutes post 200mcg salbutamol on day 5
Regular use of salbutamol results in loss of bronchoprotection. The primary outcome is to determine the onset of this tolerance.
次要结局
未报告次要终点