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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Asthma

Intervention / Treatment
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* Other: Oxford street
* Other: Hyde park


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Asthma<br>Asthma patients ranging from mild to severe | Other: Oxford street<br>* 2 h walk around Oxford street<br>Other: Hyde park<br>* 2 h walk around Hyde park<br>|
| Other: Healthy Non-Smokers<br> | Other: Oxford street<br>* 2 h walk around Oxford street<br>Other: Hyde park<br>* 2 h walk around Hyde park<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spirometry, Percentage Change in FEV1 From Baseline |  | baseline, 24 hours after | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exposure to Oxford Street, Exposure to Hyde Park