Cigarette Smoke and Susceptibility to Influenza Infection
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ClinicalTrials.gov Identifier: NCT00448617
: March 19, 2007
Last Update Posted
: May 29, 2015
University of North Carolina, Chapel Hill
Hamner Institutes for Health Sciences
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Terry Noah, MD, University of North Carolina, Chapel Hill
This study will be a descriptive comparison of the effects of live attenuated influenza virus (FluMist) on nasal inflammation and oxidative stress in healthy young adults who are not exposed to smoke vs smokers. It is hypothesized that passive exposure to second-hand smoke (SHS) results in increased susceptibility to the effects of influenza virus in nasal epithelium in humans and that these effects are mediated by SHS-induced oxidative stress
Condition or disease
Epidemiologic evidence supports a significant relationship between passive cigarette smoke exposure and increased risk for viral respiratory illnesses. Published and preliminary data suggest that airborne pollutants including tobacco smoke increase susceptibility of respiratory epithelium to infection with influenza A and that this effect is at least partially mediated by oxidative stress. However, no studies have specifically looked at the interaction between smoking and the effects of influenza virus in human volunteers.
Nasal responses of healthy adult volunteers not routinely exposed to SHS vs responses of smokers, to live attenuated influenza virus. [ Time Frame: 5-8-weeks ]
Secondary Outcome Measures
Compare replication of live attenuated influenza virus (LAIV) in nasal epithelium of seronegative healthy adult volunteers not routinely exposed to SHS vs. smokers. [ Time Frame: 5-8 weeks ]
In the setting of LAIV infection, compare markers of oxidant stress and mucosal inflammation in nasal epithelium of healthy adult volunteers not routinely exposed to SHS vs. smokers [ Time Frame: 5-8 weeks ]
Biospecimen Retention: Samples With DNA
nasal lavage fluid, urine, blood, nasal epithelial tissue from subjects who consent to have excess samples stored in our repository
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Ages Eligible for Study:
18 Years to 35 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
nonsmokers who are NOT exposed to SHS
age 18-35 years
healthy nonsmoking who are rarely exposed to SHS OR smokers
pregnancy or nursing;
history of egg allergy;
immunodeficiency (HIV or other);
on immunosuppressive drugs including corticosteroids;
history of Guillain-Barre Syndrome;
any chronic medical condition;
febrile and/or respiratory illness within past 3 weeks prior to entry into study;
prospective subjects with high baseline antibody titers against influenza will be excluded because they may be less likely to develop viral replication with LAIV.