Effects of Diesel Exhaust Followed by Administration of Nasal Spray Flu Vaccine on Individuals With & Without Allergies
FLAIR
Effects of Diesel Exhaust Particles on Influenza-induced Nasal Inflammation in Allergic Rhinitics and Non-allergic Individuals
2 other identifiers
interventional
54
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 5, 2008
CompletedFirst Posted
Study publicly available on registry
February 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedJune 3, 2015
June 1, 2015
6.2 years
February 5, 2008
June 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in IL-13 and ECP in nasal lavage fluids (NLF) compared to pre-virus baseline
1-21 days post challenge
Secondary Outcomes (7)
Duration/quantity of virus shedding
0-21 days post challenge
Change in inflammatory cells in NLF at specific time points compared to baseline
0-21 days post challenge
Change in inflammatory cytokines/chemokines and other mediators (PGE2, tryptase, MPO, adenosine) in NLF at specific time points compared to baseline
0-21 days post challenge
Post LAIV change in overall "oxidative stress" in nasal epithelial cells
0-21 days post challenge
Post LAIV change in epithelial gene expression profiles for innate immune and oxidant/antioxidant network arrays in nasal epithelial biopsies
0-21 days post challenge
- +2 more secondary outcomes
Study Arms (4)
allergic clean air
SHAM COMPARATORsubjects with allergic rhinitis will be exposed to clean air followed by LAIV
Allergic diesel
ACTIVE COMPARATORsubjects with allergic rhinitis will be exposed to diesel exhaust particles followed by LAIV
control clean air
SHAM COMPARATORHealthy control subjects will be exposed to clean air followed by LAIV
Control diesel
SHAM COMPARATORHealthy control will be exposed to diesel followed by LAIV
Interventions
Allergic subjects will be exposed to air followed by administration of live attenuated influenza virus
subjects with allergic rhinitis will be exposed to diesel exhaust particles followed by LAIV
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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")
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
US EPA Human Studies Facility
Chapel Hill, North Carolina, 27514, United States
Related Publications (2)
Pawlak EA, Noah TL, Zhou H, Chehrazi C, Robinette C, Diaz-Sanchez D, Muller L, Jaspers I. Diesel exposure suppresses natural killer cell function and resolution of eosinophil inflammation: a randomized controlled trial of exposure in allergic rhinitics. Part Fibre Toxicol. 2016 May 6;13(1):24. doi: 10.1186/s12989-016-0135-7.
PMID: 27154411DERIVEDNoah TL, Zhou H, Zhang H, Horvath K, Robinette C, Kesic M, Meyer M, Diaz-Sanchez D, Jaspers I. Diesel exhaust exposure and nasal response to attenuated influenza in normal and allergic volunteers. Am J Respir Crit Care Med. 2012 Jan 15;185(2):179-85. doi: 10.1164/rccm.201103-0465OC. Epub 2011 Oct 27.
PMID: 22071326DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Terry Noah, MD
University of North Carolina at Chapel Hill, Dept of Pediatrics / Center for Environmental Medicine, Asthma and Lung Biology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pediatrics
Study Record Dates
First Submitted
February 5, 2008
First Posted
February 15, 2008
Study Start
January 1, 2008
Primary Completion
March 1, 2014
Study Completion
April 1, 2014
Last Updated
June 3, 2015
Record last verified: 2015-06