Clinical trial NCT00448617: Cigarette Smoke and Susceptibility to Influenza Infection
Official title: Cigarette Smoke and Susceptibility to Influenza Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: live attenuated influenza virus
inflammation
flu vaccine
FluMist
smokers
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Hamner Institutes for Health Sciences
name: National Institutes of Health (NIH)
First posted: 2007-03-19
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. smokers
2. nonsmokers who are NOT exposed to SHS

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.

Eligibility criteria: 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;
* asthma;
* 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.

Primary outcomes:
measure: Nasal responses of healthy adult volunteers not routinely exposed to SHS vs responses of smokers, to live attenuated influenza virus.
timeFrame: 5-8-weeks
Secondary outcomes:
measure: Compare replication of live attenuated influenza virus (LAIV) in nasal epithelium of seronegative healthy adult volunteers not routinely exposed to SHS vs. smokers.
timeFrame: 5-8 weeks
measure: 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
timeFrame: 5-8 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Center for Environmental Medicine, Asthma and Lung Biology
state: North Carolina
Study officials:
affiliation: University of North Carolina at Chapel Hill, Dept of Pediatrics / Center for Environmental Medicine, Asthma and Lung Biology
name: Terry Noah, MD
role: PRINCIPAL_INVESTIGATOR
References: