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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02133586
Other study ID # ENDZONE
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2014
Est. completion date January 2016

Study information

Verified date August 2020
Source Environmental Protection Agency (EPA)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The U.S. Environmental Protection Agency has traditionally examined the effects of single pollutant exposure on human health outcomes; however, to provide a better assessment of pollutant exposure-associated effect on human health the Agency is moving toward a multi-pollutant approach. Ozone (O3) and nitrogen dioxide (NO2) are national ambient air quality standards (NAAQS) criteria pollutants that are major constituents of ambient air pollution. This study will address the Agency's goals by investigating the cardiopulmonary health effects of sequential exposure to O3 and NO2 in healthy adult human volunteers. The findings of this study will provide data that will inform risk assessment models for O3 and NO2 exposures. Additionally, the findings will provide insight into how the human health effects of multi-pollutant exposures differ from those of single pollutant exposures.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Other:
Ozone
Exposure to 300ppb ozone with intermittent exercise as either the first exposure in a two-exposure series or as the second exposure approximately 22 hours after the first exposure (either clean air or nitrogen dioxide) in a two-exposure series.
Nitrogen dioxide
Exposure to 500ppb nitrogen dioxide with intermittent exercise as either the first exposure in a two-exposure series or as the second exposure approximately 22 hours after the first exposure (either clean air or ozone) in a two-exposure series.

Locations

Country Name City State
United States E.P.A. Human Studies Facility Chapel Hill North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Environmental Protection Agency (EPA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Plasma cytokine levels Pre-exposure ("baseline"), immediately post-exposure, and 24 hours post-exposure
Primary Pulmonary Function Measurements are taken pre-exposure ("baseline" measurement), immediately post-exposure, and 24 hours post-exposure. Changes in forced vital capacity (FVC) and forced expiratory volume in one second (FEV1) will be assessed as indicators of change in pulmonary function. Pre-exposure ("baseline"), immediately post-exposure, and 24 hours post-exposure
Secondary Heart Rate Variability Pre-exposure ("baseline"), immediately post-exposure, and 24 hours post-exposure
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