Regular Use Effect of Inhaled Ipratropium Bromide on Airway Responsiveness to Methacholine in Well-controlled Asthma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Methacholine PD20
研究概览
简要总结
Study is looking at the development of tolerance to methacholine following regular use of ipratropium bromide in mild asthmatics.
详细描述
This study is being conducted people with well controlled (mild) asthma to determine if ipratropium bromide taken three times daily for six days (i.e. 2 puffs in the morning, 2 puffs in the afternoon and 2 puffs in the evening) followed by a final dose on the morning of day 7 reduces the effectiveness of this medication on blocking the effect of methacholine challenge.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •airway responsiveness to methacholine
- •adequate baseline lung function
- •no respiratory infection or exposure to stimuli that may alter response to methacholine within 4 weeks
排除标准
- •pregnancy
- •current smoker
- •requirement for medications other than salbutamol that will interfere with airway response to methacholine
研究组 & 干预措施
Ipratropium bromide
20mcg bronchodilator inhaler
干预措施: Ipratropium Metered Dose Inhaler (Drug)
placebo
matching bronchodilator inhaler
干预措施: placebo metered dose inhaler (Drug)
结局指标
主要结局
Methacholine PD20
时间窗: 24 hours after last dose
dose of methacholine required to induce a 20% fall in FEV1 (volume of air forcefully exhaled in one second)
次要结局
未报告次要终点
研究者
Don Cockcroft
Professor
University of Saskatchewan