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临床试验/NCT00127062
NCT00127062已完成不适用

Health Effects of Diesel Exhaust in Asthmatic Patients: A Real-world Study in a London Street

Imperial College London0 个研究点目标入组 60 人开始时间: 2003年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
主要终点
Spirometry, Percentage Change in FEV1 From Baseline

研究概览

简要总结

Acute exposure to diesel exhaust under normal city conditions leads to a worsening of symptoms of asthma, with reduction in lung function in asthmatic nonsmoking adults, dependent on the exposure dose and on the background severity of asthma.

The worsening asthma is accompanied by increased oxidative stress and inflammation in the lungs.

详细描述

The investigators will recruit 60 nonsmoking asthmatics of mild and of moderate severity. They will be exposed to Oxford St. or to Hyde Park for 2 hours each, at a walking pace. Real time exposure to PM2.5, carbon monoxide and nitrogen dioxide will be made each time. Health outcome measurements will be made before and after exposure to each street. Statistical analyses will be made to examine the effect of diesel exposure on changes in health outcome measures.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects will be selected according to the current severity of their asthma; thirty from Steps 1 and 2 and thirty from Step 3 of the World Health Organization (WHO) Global Initiative for Asthma (GINA) asthma guidelines. These will include mild and moderate asthmatic states. Depending on baseline FEV1, subjects will undergo either a methacholine bronchial hyperresponsiveness assessment or airways reversibility testing. Subjects with normal FEV1 (>80% predicted) or normal FEV1/FVC ratio will undergo methacholine challenge. Subjects with FEV1 <80% predicted will undergo airways reversibility testing. Subjects must have either a PC20 of less than 8mg/ml methacholine, or improvement in FEV1 of 12% or more, following inhalation of short acting β-agonist (salbutamol 200μg from metered dose inhaler [MDI]). Skin prick testing will be conducted for common allergens (house dust mite, grass pollen, aspergillus fumigatus and cat hair). The results will only be for descriptive purposes, not as subject inclusion/exclusion criteria. Subjects may be atopic or non-atopic (according to history and allergy testing).

排除标准

  • 未提供

结局指标

主要结局

Spirometry, Percentage Change in FEV1 From Baseline

时间窗: baseline, 24 hours after

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fan Chung

Professor

Imperial College London

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