Chronic Obstructive Pulmonary Disease Clinical Trial
To determine the effects of chronic ozone exposure on lung function in young men and women.
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.
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