Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006306
Status:
COMPLETED
Last Update Posted:
2016-02-29
First Post:
2000-09-28
Brief Title:
Effects of Chronic Ozone Exposure on Lung Function
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2006-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 US 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 lavagebiopsy to evaluate relationships between measures of inflammation injuryrepair and oxidant induced damagerepair 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
A large part of the US 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 lavagebiopsy to evaluate relationships between measures of inflammation injuryrepair and oxidant induced damagerepair 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL060689 | NIH | None | httpsreporternihgovquickSearchR01HL060689 |