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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00127062
First Posted: August 5, 2005
Last Update Posted: March 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Health Effects Institute
Information provided by (Responsible Party):
Fan Chung, Imperial College London
  Purpose

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.


Condition Intervention Phase
Asthma Other: Exposure Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Health Effects of Diesel Exhaust in Asthmatic Patients: A Real-world Study in a London Street

Further study details as provided by Fan Chung, Imperial College London:

Primary Outcome Measures:
  • Spirometry [ Time Frame: During exposure and 24 hours after ]

Biospecimen Retention:   Samples Without DNA
Exhaled breath condensate

Estimated Enrollment: 60
Study Start Date: May 2003
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Asthma
Asthma patients ranging from mild to severe
Other: Exposure
Healthy Non-Smokers Other: Exposure

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00127062


Sponsors and Collaborators
Imperial College London
Health Effects Institute
Investigators
Principal Investigator: Paul Cullinan, MD Imperial College London
Study Director: Fan Chung, MD Imperial College London
Principal Investigator: Mark Nieuwenhuijsen, PhD Imperial College London
Principal Investigator: Jim Zhang, PhD Rutgers U & UMDNJ
  More Information

Responsible Party: Fan Chung, Professor, Imperial College London
ClinicalTrials.gov Identifier: NCT00127062     History of Changes
Other Study ID Numbers: 03-194
First Submitted: August 4, 2005
First Posted: August 5, 2005
Last Update Posted: March 26, 2015
Last Verified: August 2005

Keywords provided by Fan Chung, Imperial College London:
Exposure to Oxford Street
Exposure to Hyde Park