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Sponsors and Collaborators: |
The University of North Carolina, Chapel Hill Environmental Protection Agency (EPA) |
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Information provided by: | The University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT00617110 |
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) or 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
Condition | Intervention |
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Allergic Rhinitis |
Biological: live attenuated influenza virus (LAIV) with clean air Biological: LAIV and diesel exhaust particles |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Investigator), Parallel Assignment |
Official Title: | Effects of Diesel Exhaust Particles on Influenza-induced Nasal Inflammation in Allergic Rhinitics and Non-allergic Individuals |
Estimated Enrollment: | 18 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
subjects with or without allergic rhinitis will be exposed to clean air followed by LAIV
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Biological: live attenuated influenza virus (LAIV) with clean air
Allergic or non-allergic subjects will be exposed to air followed by administration of live attenuated influenza virus
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2: Active Comparator
subjects with or without allergic rhinitis will be exposed to diesel exhaust particles followed by LAIV
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Biological: LAIV and diesel exhaust particles
subjects with or without allergic rhinitis will be exposed to diesel exhaust particles followed by LAIV
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Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Normal lung function, defined as (Knudson 1976/1984 predicted set):
Exclusion Criteria:
United States, North Carolina | |
US EPA Human Studies Facility | |
Chapel Hill, North Carolina, United States, 27514 |
Principal Investigator: | Terry Noah, MD | University of North Carolina at Chapel Hill, Dept of Pediatrics / Center for Environmental Medicine, Asthma and Lung Biology |
Responsible Party: | UNC Center for Environmental Medicine, Asthma and Lung Biology ( Terry Noah, MD/Principal Investigator ) |
Study ID Numbers: | 07-1064 |
Study First Received: | February 5, 2008 |
Last Updated: | August 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00617110 History of Changes |
Health Authority: | United States: Institutional Review Board |
diesel exhaust particles live attenuated influenza virus vaccine flu vaccine |
Virus Diseases Hypersensitivity Otorhinolaryngologic Diseases Respiratory Tract Infections |
Respiratory Tract Diseases Influenza, Human Rhinitis Inflammation |
Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases Rhinitis Nose Diseases |