Cigarette Smoke and Susceptibility to Influenza Infection

Sponsor

University of North Carolina, Chapel Hill (Other)

Overall Status

Completed

CT.gov ID

NCT00448617

Collaborator

Hamner Institutes for Health Sciences (Other), National Institutes of Health (NIH) (NIH)

138

Enrollment

Location

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy

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

Actual Enrollment :

138 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Cigarette Smoke and Susceptibility to Influenza Infection

Study Start Date :

Jul 1, 2006

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Sep 1, 2011

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

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;
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UNC Center for Environmental Medicine, Asthma and Lung Biology	Chapel Hill	North Carolina	United States	27599-7310

Sponsors and Collaborators

University of North Carolina, Chapel Hill
Hamner Institutes for Health Sciences
National Institutes of Health (NIH)

Investigators

Principal Investigator: Terry Noah, MD, University of North Carolina at Chapel Hill, Dept of Pediatrics / Center for Environmental Medicine, Asthma and Lung Biology