Cigarette Smoke and Susceptibility to Influenza Infection
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 138
- Locations
- 1
- Primary Endpoint
- Nasal responses of healthy adult volunteers not routinely exposed to SHS vs responses of smokers, to live attenuated influenza virus.
Study Overview
Brief Summary
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
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •age 18-35 years
- •healthy nonsmoking who are rarely exposed to SHS OR smokers
Exclusion Criteria
- •pregnancy or nursing;
- •history of egg allergy;
- •aspirin therapy;
- •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.
Outcomes
Primary Outcomes
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 Outcomes
- Compare replication of live attenuated influenza virus (LAIV) in nasal epithelium of seronegative healthy adult volunteers not routinely exposed to SHS vs. smokers.(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(5-8 weeks)
Investigators
Terry Noah, MD
Professor of Pediatrics
University of North Carolina, Chapel Hill