Cigarette Smoke and Susceptibility to Influenza Infection

Completed

• Conditions: Healthy

• Registration Number: NCT00448617
• Lead Sponsor: University of North Carolina, Chapel Hill

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 Timeline

• Study Start: 2006-07
• Study First Submitted: 2007-03-15
• Study First Submitted QC: 2007-03-16
• Study First Posted: 2007-03-19
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-28
• Last Update Posted: 2015-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

• age 18-35 years
• healthy nonsmoking who are rarely exposed to SHS OR smokers

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Nasal responses of healthy adult volunteers not routinely exposed to SHS vs responses of smokers, to live attenuated influenza virus.	5-8-weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

UNC Center for Environmental Medicine, Asthma and Lung Biology; 🇺🇸 Chapel Hill, North Carolina, United States