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临床试验/NCT01792232
NCT01792232已完成不适用

Effect of Exposure to Allergens and Air Pollution on Lung Function and Immunity

University of British Columbia2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2011年10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
18
试验地点
2
主要终点
Allergen-specific IgE

研究概览

简要总结

The investigators are investigating the effects of combined exposures to diesel exhaust and allergens on lung function and on the immune system. After exposing individuals to either filtered air or carefully controlled levels of diesel exhaust in our exposure chamber, The investigators will use a procedure called bronchoscopy (whereby a thin, flexible tube is passed down the throat and into the lungs) to place a small amount of allergen directly in the lung. 48h later, the bronchoscopy will be repeated so that samples can be collected from the lungs. After 1mo, the entire procedure will be repeated with the alternate exposure.

详细描述

  1. Purpose/Objective:

To study the effects of diesel exhaust particles on lung function and on allergic responses. 2. Hypotheses:

Hypothesis 1: DE exposure augments systemic oxidative stress from allergen challenge in allergen-sensitized individuals.

Hypothesis 2: DE exposure augments allergen-specific immune response in allergen-challenged airways in sensitized individuals. These responses will be greater in asthmatic individuals than in non-asthmatics. 3. Justification:

The use of diesel engines is increasing because they are more fuel-efficient than gasoline engines. However, diesel engines produce different emissions than gasoline engines. Diesel exhaust is emitted from the tailpipe of both "on-road" diesel engine vehicles (diesel cars, buses and trucks) and "non-road" diesel engines (locomotives, marine vessels and some construction equipment). Diesel exhaust consists of both gaseous and particulate air pollutants. Since people with asthma and allergic diseases appear to be sensitive to air pollution, we would like to know how diesel exhaust (DE) can affects your respiratory and immune systems. We are expecting that any responses that may occur will only be detectable through careful examination of cells and tissues (e.g., bronchoalveolar lavage (fluid from your lungs), blood, urine). Understanding these potentially subtle changes will help us prevent health problems associated with air pollution in the future. 4. Research Method:

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
19 Years 至 49 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 19 and 49 years.
  • Non-smoking.
  • Positive skin prick test for at least one of: birch, grass, or dust

排除标准

  • Using inhaled corticosteroids
  • Pregnant or planning to be pregnant in the next 12 months / Breastfeeding
  • Usage of bronchodilators more than three times per week.
  • Co-morbidities (as assessed by the primary investigator)
  • Taking part in other studies
  • Unwilling to withhold bronchodilator, aspirin, anti-coagulant, antihistamine or decongestant medications or caffeine prior to testing procedures.
  • FEV1(Forced expiratory volume in one second) < 70% predicted.
  • Allergy to lidocaine, fentanyl, midazolam or salbutamol.
  • Unstable asthma (i.e exacerbation in 2 weeks preceding testing)

结局指标

主要结局

Allergen-specific IgE

时间窗: 48 hours

BAL IgE specific to the allergen used for allergen challenge will be assessed at 48 hrs, from the BAL, using immunocap assay

次要结局

  • Human immune response(48 hours)
  • Airway reactivity(48 hours)
  • Oxidative stress(48 hours)

研究者

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

Christopher Carlsten

Principal Investigator

University of British Columbia

研究点 (2)

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