Duration of Bronchoprotection of the Long Acting Muscarinic Antagonists Tiotropium and Glycopyrronium Against Methacholine Induced Bronchoconstriction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Change from baseline methacholine bronchoprotection at 96 hours
研究概览
简要总结
The study will assess the duration of protection of single doses of 2 different long acting muscarinic antagonists against methacholine induced bronchoconstriction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female asthmatics > 19 years of age
- •baseline methacholine PC20 less than or equal to 4mg/ml
- •baseline lung function >65% predicted
- •non-smoker and less than 10 pack year smoking history
排除标准
- •use of anticholinergic within 30 days of Visit 1
- •poorly controlled asthma
- •pregnant or nursing
- •respiratory illness within 4 weeks of Visit 1
- •exposure to an agent that triggered asthma worsening (e.g. allergen) within 4 weeks of Visit 1
研究组 & 干预措施
tiotropium
2 inhalations of 2.5mcg/inhalation tiotropium from Respimat inhaler and 1 inhalation of placebo from Breezehaler 1 hour prior to methacholine challenge
干预措施: Tiotropium (Drug)
tiotropium
2 inhalations of 2.5mcg/inhalation tiotropium from Respimat inhaler and 1 inhalation of placebo from Breezehaler 1 hour prior to methacholine challenge
干预措施: Respimat (Device)
tiotropium
2 inhalations of 2.5mcg/inhalation tiotropium from Respimat inhaler and 1 inhalation of placebo from Breezehaler 1 hour prior to methacholine challenge
干预措施: Breezehaler (Device)
glycopyrronium
1 inhalation of 50mcg glycopyrronium from Breezehaler and 2 inhalations from placebo Respimat inhaler 1 hour prior to methacholine challenge
干预措施: glycopyrronium (Drug)
glycopyrronium
1 inhalation of 50mcg glycopyrronium from Breezehaler and 2 inhalations from placebo Respimat inhaler 1 hour prior to methacholine challenge
干预措施: Respimat (Device)
glycopyrronium
1 inhalation of 50mcg glycopyrronium from Breezehaler and 2 inhalations from placebo Respimat inhaler 1 hour prior to methacholine challenge
干预措施: Breezehaler (Device)
结局指标
主要结局
Change from baseline methacholine bronchoprotection at 96 hours
时间窗: pre treatment versus 96 hour post treatment
assessed by dose shift of geometric mean methacholine PC20 data
次要结局
- Change from baseline methacholine bronchoprotection at 1 hour(pre treatment versus 1 hour post treatment)
- Change from baseline methacholine bronchoprotection at 24 hours(pre treatment versus 24 hours post treatment)
- Change from baseline methacholine bronchoprotection at 48 hours(pre treatment versus 48 hours post treatment)
- Change from baseline methacholine bronchoprotection at 72 hours(pre treatment versus 72 hours post treatment)
研究者
Don Cockcroft
Professor
University of Saskatchewan