NCT02327234已完成不适用
Assessment of Repeated Allergen Challenge and the Effects of Ibuprofen on the Inflammatory Process
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Airway response to inhaled allergen
研究概览
简要总结
The study will assess airway responses in mild atopic asthmatics undergoing repeat allergen challenge testing and will investigate whether ibuprofen changes the response.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of mild asthma, currently well controlled requiring only a bronchodilator (e.g. salbutamol) as needed and infrequently
- •has allergies that trigger asthma
- •responds to methacholine challenge at 16mg/ml or less
- •has FEV1 > 69.5% predicted
排除标准
- •respiratory illness within 4 weeks
- •other medical condition assessed by the principal investigator that would put the participant at risk or influence the integrity of the data
- •pregnant or lactating females
- •hypersensitivity to ibuprofen
研究组 & 干预措施
Ibuprofen
Experimental
400mg (2X200mg) ibuprofen single dose once
干预措施: ibuprofen (Drug)
Placebo
Placebo Comparator
identical appearing lactose capsules single dose 2 capsules once
干预措施: Placebo (Drug)
结局指标
主要结局
Airway response to inhaled allergen
时间窗: at time of allergen inhalation challenge and for 7 hours after
area under forced expiratory volume in one second versus time curve; 0-3hours (early response) and 3-7 hours (late response)
次要结局
- Airway response to inhaled methacholine(day before allergen inhalation challenge and 8 hours after allergen inhalation challenge)
研究者
Don Cockcroft
Professor
University of Saskatchewan
研究点 (1)
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