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Effects of Chronic Ozone Exposure on Lung Function

Primary Purpose

Lung Diseases, Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Lung Diseases

Eligibility Criteria

18 Years - 21 Years (Adult)All SexesDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 28, 2000
    Last Updated
    February 26, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00006306
    Brief Title
    Effects of Chronic Ozone Exposure on Lung Function
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    January 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1999 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    To determine the effects of chronic ozone exposure on lung function in young men and women.
    Detailed Description
    BACKGROUND: A large part of the U.S. population is exposed to ambient ozone (O3) concentrations that are associated with acute respiratory health effects; however, little is known about the effects on human respiratory health of long-term exposure to such ambient concentrations. Chronic exposure of non-human primates to high concentrations of O3 are associated with pathologic changes in the centriacinar region of the lung that are similar to changes observed in young cigarette smokers. This is the first detailed epidemiologic study of the effects of chronic exposure to an air pollutant based on individual estimates of lifetime exposure and controlled exposure data. The study tests a specific toxicologic model in humans that has relevance for chronic respiratory disease and explores mechanisms of effects. DESIGN NARRATIVE: The study tested the hypothesis that, in humans, there was an exposure-response relationship between the amount of chronic exposure to ambient O3 and measures of lung function that reflected changes in the centriacinar region of the human lung (FEF25-75); and this relationship was not seen with measures of more proximal airway function (FEV1). First-year UC Berkeley students, ages 18-21 yrs, who were lifelong residents of the Los Angles Basin, (high O3) and the San Francisco Bay Area, (low O3) were studied. Lifetime exposure to ambient O3 was estimated with methods developed by the investigators that combined questionnaire and ambient O3 data. Lung function was assessed with maximum expiratory flow-volume curves. Students were studied after 4-6 months of low ambient O3 exposure and immediately after 2-3 months of exposure to summertime O3. Students from each area who were at the upper and lower tails of the FEF25-75 distribution underwent two controlled O3 exposures (seasonal as above) followed by bronchoalveolar lavage/biopsy to evaluate relationships between measures of inflammation, injury/repair and oxidant induced damage/repair and FEF25-75. Regression was used to evaluate relationships between lifetime O3 exposure and lung function, adjusted for past and family respiratory history, allergy history, home characteristics, exposure to environmental tobacco smoke and particle air pollution and NO2. The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Diseases, Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease

    7. Study Design

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ira Tager
    Organizational Affiliation
    University of California, Berkeley

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16222164
    Citation
    Tager IB, Balmes J, Lurmann F, Ngo L, Alcorn S, Kunzli N. Chronic exposure to ambient ozone and lung function in young adults. Epidemiology. 2005 Nov;16(6):751-9. doi: 10.1097/01.ede.0000183166.68809.b0.
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    Effects of Chronic Ozone Exposure on Lung Function

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