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

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oxford street
Hyde park
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Asthma focused on measuring Exposure to Oxford Street, Exposure to Hyde Park

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Asthma

    Healthy Non-Smokers

    Arm Description

    Asthma patients ranging from mild to severe

    Outcomes

    Primary Outcome Measures

    Spirometry, Percentage Change in FEV1 From Baseline

    Secondary Outcome Measures

    Full Information

    First Posted
    August 4, 2005
    Last Updated
    October 22, 2019
    Sponsor
    Imperial College London
    Collaborators
    Health Effects Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00127062
    Brief Title
    Health Effects of Diesel Exhaust in Asthmatic Patients: A Real-world Study in a London Street
    Official Title
    Health Effects of Diesel Exhaust in Asthmatic Patients: A Real-world Study in a London Street
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2003 (undefined)
    Primary Completion Date
    August 2006 (Actual)
    Study Completion Date
    August 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Imperial College London
    Collaborators
    Health Effects Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma
    Keywords
    Exposure to Oxford Street, Exposure to Hyde Park

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Asthma
    Arm Type
    Experimental
    Arm Description
    Asthma patients ranging from mild to severe
    Arm Title
    Healthy Non-Smokers
    Arm Type
    Other
    Intervention Type
    Other
    Intervention Name(s)
    Oxford street
    Intervention Description
    2 h walk around Oxford street
    Intervention Type
    Other
    Intervention Name(s)
    Hyde park
    Intervention Description
    2 h walk around Hyde park
    Primary Outcome Measure Information:
    Title
    Spirometry, Percentage Change in FEV1 From Baseline
    Time Frame
    baseline, 24 hours after

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Paul Cullinan, MD
    Organizational Affiliation
    Imperial College London
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Fan Chung, MD
    Organizational Affiliation
    Imperial College London
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Mark Nieuwenhuijsen, PhD
    Organizational Affiliation
    Imperial College London
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Jim Zhang, PhD
    Organizational Affiliation
    Rutgers U & UMDNJ
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    19449765
    Citation
    Zhang JJ, McCreanor JE, Cullinan P, Chung KF, Ohman-Strickland P, Han IK, Jarup L, Nieuwenhuijsen MJ. Health effects of real-world exposure to diesel exhaust in persons with asthma. Res Rep Health Eff Inst. 2009 Feb;(138):5-109; discussion 111-23.
    Results Reference
    result

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

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