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

Sponsor:	University of North Carolina, Chapel Hill
Collaborators:	National Institute of Environmental Health Sciences (NIEHS) Environmental Protection Agency (EPA)
Information provided by (Responsible Party):	Terry Noah, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00617110

Purpose

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

Condition	Intervention
Allergic Rhinitis	Biological: live attenuated influenza virus (LAIV) with clean air Biological: LAIV and diesel exhaust particles

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator)
Official Title:	Effects of Diesel Exhaust Particles on Influenza-induced Nasal Inflammation in Allergic Rhinitics and Non-allergic Individuals

Resource links provided by NLM:

MedlinePlus related topics: Allergy Flu

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:

Change in IL-13 and ECP in nasal lavage fluids (NLF) compared to pre-virus baseline [ Time Frame: 1-21 days post challenge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Duration/quantity of virus shedding [ Time Frame: 0-21 days post challenge ] [ Designated as safety issue: No ]
Change in inflammatory cells in NLF at specific time points compared to baseline [ Time Frame: 0-21 days post challenge ] [ Designated as safety issue: No ]
Change in inflammatory cytokines/chemokines and other mediators (PGE2, tryptase, MPO, adenosine) in NLF at specific time points compared to baseline [ Time Frame: 0-21 days post challenge ] [ Designated as safety issue: No ]
Post LAIV change in overall "oxidative stress" in nasal epithelial cells [ Time Frame: 0-21 days post challenge ] [ Designated as safety issue: No ]
Post LAIV change in epithelial gene expression profiles for innate immune and oxidant/antioxidant network arrays in nasal epithelial biopsies [ Time Frame: 0-21 days post challenge ] [ Designated as safety issue: No ]
Change in levels and activities of circulating white blood cells, including eosinophils, basophils, monocytes, and lymphocytes [ Time Frame: 0-21 days post challenge ] [ Designated as safety issue: No ]
Outcomes for GSTM1 null vs. sufficient genotype individuals [ Time Frame: 0-21 days post challenge ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	January 2008
Estimated Study Completion Date:	April 2015
Estimated Primary Completion Date:	January 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sham Comparator: 1 subjects with allergic rhinitis will be exposed to clean air followed by LAIV	Biological: live attenuated influenza virus (LAIV) with clean air Allergic subjects will be exposed to air followed by administration of live attenuated influenza virus Other Name: FluMist
Active Comparator: 2 subjects with allergic rhinitis will be exposed to diesel exhaust particles followed by LAIV	Biological: LAIV and diesel exhaust particles subjects with allergic rhinitis will be exposed to diesel exhaust particles followed by LAIV Other Name: FLuMist

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Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Normal lung function, defined as (Knudsen 1976/1984 predicted set):
- FVC of > 75 % of that predicted for gender, ethnicity, age and height
- FEV1 of > 75 % of that predicted for gender, ethnicity, age and height
- FEV1/FVC ratio of .70
Oxygen saturation of > 94 %
Normal blood pressure (Systolic between 140 - 90, Diastolic between 90-60 mm Hg)
Symptom Score no greater than 6 (out of a possible 39) for total symptom score
On the day of a challenge, body temperature must be no greater than 37.8 degrees, measured orally

Exclusion Criteria:

A history of significant chronic illnesses (to include diabetes, autoimmune diseases, immunodeficiency state, known ischemic heart disease, chronic respiratory diseases such as chronic obstructive pulmonary disease or asthma, hypertension)
Allergy to any medications which may be used in the course of this study (albuterol, acetaminophen, aspirin or non-steroidal anti-inflammatory agents, corticosteroids)
Positive pregnancy test within 48 hours of the time of challenge
Medications which may impact the results of the experimental viral infection, interfere with any other medications potentially used in the study (to include nasal or oral corticosteroids, beta adrenergic antagonists, non-steroidal anti-inflammatory agents) or suggest an ongoing illness (such as antibiotics)
Acute, non-chronic, medical conditions, including (but not limited to) pneumonia or bronchitis requiring antibiotics, febrile illnesses, flu-like symptoms must be totally resolved symptomatically for 3 weeks
Unspecified illnesses, which in the judgment of the investigator increase the risk associated with the experimental LAIV infection, will be a basis for exclusion
Use of any inhaled substance (for medical or recreational purposes)
Receipt of flu vaccine of any type (injection or nasal spray) during the prior season (2006/2007)
Current use of allergy immunotherapy ("allergy shots")

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617110

Locations

United States, North Carolina
US EPA Human Studies Facility
Chapel Hill, North Carolina, United States, 27514

Sponsors and Collaborators

University of North Carolina, Chapel Hill

National Institute of Environmental Health Sciences (NIEHS)

Environmental Protection Agency (EPA)

Investigators

Principal Investigator:

Terry Noah, MD

University of North Carolina at Chapel Hill, Dept of Pediatrics / Center for Environmental Medicine, Asthma and Lung Biology

More Information

No publications provided

Responsible Party:	Terry Noah, MD, Professor of Pediatrics, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00617110 History of Changes
Other Study ID Numbers:	07-1064, 2R01ES013611
Study First Received:	February 5, 2008
Last Updated:	December 6, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:

diesel exhaust particles
live attenuated influenza virus vaccine
flu vaccine

Additional relevant MeSH terms:

Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on February 12, 2012