Salbutamol Reversal of Methacholine Induced Bronchoconstriction: Vibrating Mesh Nebulizer Versus Pressurized Metered Dose Inhaler
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Lung function recovery
研究概览
简要总结
The study will compare salbutamol reversibility of methacholine induced bronchoconstriction between a pressurized metered dose inhaler with a spacer versus nebulizer administration using a vibrating mesh nebulizer.
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
- •age (years) at least 18, male or female
- •no confounding health issue (i.e. no health conditions, other than asthma, that would put the participant at risk or affect data integrity)
- •baseline FEV1 ≥ 65% predicted (per Quanjer GLI 2012)
- •methacholine PD20 ≤ 800mcg
排除标准
- •respiratory infection within 4 weeks of Visit 1
- •exposure to triggers of respiratory symptoms within 4 weeks of Visit 1
- •currently pregnant or breastfeeding
- •current smoker (cigarettes, vaping)
研究组 & 干预措施
placebo
normal saline will be administered with a vibrating mesh nebulizer and 200mcg of placebo will be administered using a pressurized metered dose inhaler plus spacer
干预措施: placebo (Other)
salbutamol delivered via pressurized metered dose inhaler
200mcg of salbutamol will be delivered using a pressurized metered dose inhaler plus spacer
干预措施: salbutamol pressurized metered dose inhaler (Drug)
salbutamol delivered with vibrating mesh nebulizer
200microliters of salbutamol will be administered using a vibrating mesh nebulizer
干预措施: salbutamol aqueous solution (Drug)
结局指标
主要结局
Lung function recovery
时间窗: up to 60 minutes post salbutamol administration
Maximal recovery in FEV1 and FVC (absolute volume and percent)
次要结局
- Time to lung function recovery(0-60 minutes)
- Heart rate(0-60 minutes)
研究者
Don Cockcroft
Professor
University of Saskatchewan