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Interaction Effects of Temperature and Ozone

NCT01981135 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2015-02-10

No results posted yet for this study

Summary

Purpose: The purpose of this protocol is to understand how individuals respond to the air pollutant ozone at elevated temperatures. Ultimately, this will help us understand what the risks from poor air quality are during a heat wave.

Participants: We will recruit up to 30 healthy adults, 18-55 years old, to participate in this study.

Procedures (methods): Subjects will be exposed to clean air and to 0.3 ppm of ozone for 2 hours with intermittent exercise in a controlled environment chamber. For each exposure the temperature in the chamber will be between 31-34oC (88-93 oF). Because the aim of the study is to mimic high exposure during a heat wave, we will perform exposures only on days when mean ambient temperatures was less than 24 oC in Chapel Hill on the previous day.

Primary endpoints will include spirometry and Heart Rate Variability monitoring. Secondary endpoints will include analysis of blood clotting/coagulation factors, and analysis of soluble factors present in plasma.

Conditions

  • Exposure to Environmental Pollution, Non-occupational

Interventions

OTHER

Clean Air

Each subject will be exposed to clean air for 2 hours. The exposure atmosphere will be at a temperature between 31-34oC (88-93 oF) and approximately 40 + 10% RH. Subjects will exercise on a bike. Each exercise session will consist of a 15 minute exercise interval at a level of up to 25 L/min/m2BSA followed by a 15 minute rest period.

OTHER

Ozone

Each subject will be exposed up to 0.3ppm ozone for 2 hours. The exposure atmosphere will be at a temperature between 31-34oC (88-93 oF) and approximately 40 + 10% RH. Subjects will exercise on a bike. Each exercise session will consist of a 15 minute exercise interval at a level of up to 25 L/min/m2BSA followed by a 15 minute rest period.

Sponsors & Collaborators

  • Environmental Protection Agency (EPA)

    lead FED

Principal Investigators

  • David Diaz-Sanchez, PhD · U.S. Environmental Protection Agency

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2014-03-31
Completion
2015-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01981135 on ClinicalTrials.gov