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Effects of Diesel Exhaust Followed by Administration of Nasal Spray Flu Vaccine on Individuals With & Without Allergies

NCT00617110 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2015-06-03

No results posted yet for this study

Summary

Allergic rhinitis (AR) is a condition that exists when an individual with a specific allergy reacts to that allergen resulting in a runny and/or stuffy nose, postnasal drip, and possible symptoms of sneezing, scratchy throat, itchy nose, ears or throat. When the allergic person is exposed to such an allergen, the body reacts with overproduction of certain chemicals which cause inflammation and subsequent symptoms of AR. These responses are related to the body's hyperreactive response to exposure to an otherwise harmless substance such as dust, ragweed, pollen, cat dander etc.

There are data to suggest that air pollution resulting from diesel exhaust can increase the body's response to airway inflammation caused by virus.

The purpose of this research study is to determine if individuals with AR have increased inflammatory responses to flu virus following exposure to diesel exhaust (DE) vs exposure to clean air compared to how individuals who do not have allergies respond to the same exposure conditions. The hypothesis for this study is that diesel exhaust exacerbates LAIV-induced allergic nasal inflammation, using controlled exposures in AR volunteers compared to non-allergic individuals

Conditions

  • Allergic Rhinitis

Interventions

OTHER

live attenuated influenza virus (LAIV) with clean air

Allergic subjects will be exposed to air followed by administration of live attenuated influenza virus

OTHER

LAIV and diesel exhaust particles

subjects with allergic rhinitis will be exposed to diesel exhaust particles followed by LAIV

Sponsors & Collaborators

  • National Institute of Environmental Health Sciences (NIEHS)

    collaborator NIH

  • Environmental Protection Agency (EPA)

    collaborator FED

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Terry Noah, MD · University of North Carolina at Chapel Hill, Dept of Pediatrics / Center for Environmental Medicine, Asthma and Lung Biology

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2014-03-31
Completion
2014-04-30

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 NCT00617110 on ClinicalTrials.gov