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Epigenetic Effects of Diesel Exhaust and Ozone Exposure

NCT01492517 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2016-01-18

No results posted yet for this study

Summary

Purpose: The purpose of this protocol is to compare the genetic and epigenetic effects between diesel exhaust and ozone exposure in healthy individuals and in mild/moderate asthmatics.

Participants: The investigators will recruit up to 30 mild to moderate asthmatics and up to 50 healthy adults to participate in this study.

Procedures (methods): Subjects will be exposed to clean air, to 300 µg/m3 of diesel exhaust for 2 hours and to 0.3 ppm of ozone for 2 hours with intermittent exercise in a controlled environment chamber. Primary endpoints will include spirometry and lung cell changes post-exposure. Secondary endpoints will include analysis of blood clotting/coagulation factors, Holter monitoring of cardiac parameters, analysis of soluble factors present in plasma and bronchial lavage and analysis of intracellular factors present in lung tissue obtained from a brush biopsy.

Conditions

  • Exposure to Pollution
  • Inhalation of Ozone

Interventions

OTHER

Ozone exposure

Exposure to 0.3ppm ozone for 2 hours

OTHER

Diesel exhaust

Diesel exhaust generated from a diesel generator delivered to the exposure at a target concentration of 300 μg/m3

OTHER

Ozone18

Exposure to ozone generated using the heavy non-radioactive isotope of oxygen (18O).

OTHER

Clean Air

Exposure to air which has been scrubbed to remove air pollutants including ozone and particles.

Sponsors & Collaborators

  • Environmental Protection Agency (EPA)

    lead FED

Principal Investigators

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

  • Kelly Duncan, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2013-06-30
Completion
2015-05-31

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 NCT01492517 on ClinicalTrials.gov