The Effect of Antihistamines on Methacholine Challenge Testing in Asthma Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- change in methacholine pc20
研究概览
简要总结
The asthmatic airway is identified and studied using inhaled agents such as histamine and methacholine. The use of antihistamines prior to the test will inhibit the test result if histamine is used to cause airway constriction. If using methacholine, this may also be true depending on whether old (e.g. benadryl) or new (e.g. desloratadine) antihistamines are used. This study will look at the effect of old and new antihistamines on inhaled methacholine challenge response in individuals with mild asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 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
- •Baseline forced expiratory volume in 1s (FEV1) of 70% or more of predicted
- •Methacholine provocative concentration causing a 20% fall in FEV1 16mg/ml or less
- •No respiratory infection or change in allergen exposure for 4 weeks prior to screening and throughout the study
- •No significant medical co-morbidities
排除标准
- •pregnant or breastfeeding females
- •unable to withhold antihistamines, anticholinergics, long acting bronchodilators and combination therapies
研究组 & 干预措施
diphenhydramine
50mg dose given as two 25mg capsules
干预措施: Diphenhydramine (Drug)
cetirizine
10mg dose given as 1 10mg capsule and 1 placebo capsule
干预措施: cetirizine (Drug)
desloratadine
5mg dose given as 1 5mg capsule and 1 placebo capsule
干预措施: desloratadine (Drug)
placebo
given as 2 placebo capsules
干预措施: placebo (Drug)
结局指标
主要结局
change in methacholine pc20
时间窗: change from baseline (pre dose) at 2 hours (post dose)
次要结局
未报告次要终点
研究者
Don Cockcroft
Professor
University of Saskatchewan