Controlled Exposure to Diesel Exhaust in Subjects With Allergic Rhinitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Airway inflammation
研究概览
简要总结
Proximity to traffic, particularly to diesel-powered heavy-duty vehicles, has been associated with inducing and enhancing allergies in children and adults. To investigate the basis for this association, a controlled exposure of allergic rhinitics to diesel exhaust was performed at a dose known to be pro-inflammatory in healthy individuals.
The hypothesis was that airway inflammation would be augmented in allergic rhinitics following exposure to diesel exhaust at an environmentally pertinent particulate matter concentration.
Fourteen allergic rhinitics were exposed in a double-blinded, randomised trial to both diesel exhaust at 100 microgram/m3 PM10 (representing an aerosol of nanoparticulate combustion particles, mean diameter 80 nm) and filtered air for two hours on separate occasions. Bronchoscopy with endobronchial mucosal biopsies and airway lavage was performed 18 hours post-exposure, and samples were analysed for markers of inflammation.
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
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of seasonal allergic rhinitis requiring medical treatment only during the pollen season and were classified as mild and intermittent according to ARIA guidelines.
- •Positive skin prick test to airborne allergens
- •Normal lung function
- •Negative Metacholine challenge
排除标准
- •Current smoking or a previous history of smoking.
- •Chest infection within six weeks prior to or during the study
- •Current use of non-steroidal anti-inflammatory drugs
- •Current vitamin C or E supplementation
- •Current use of topical nasal steroids.
结局指标
主要结局
Airway inflammation
时间窗: 18 hours post exposure
Bronchoscopy with endobronchial mucosal biopsies and airway lavage was performed 18 hours post-exposure to diesel exhaust and filtered air, and samples were analysed for markers of inflammation.
次要结局
未报告次要终点
研究者
Dr Annelie F Behndig, MD PhD
MD PhD
University Hospital, Umeå