Cigarette Smoke and Susceptibility to Influenza Infection - Full Text View

Sponsor:	University of North Carolina, Chapel Hill
Collaborators:	Hamner Institutes for Health Sciences National Institutes of Health (NIH)
Information provided by (Responsible Party):	Terry Noah, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00448617

Purpose

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
Healthy

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Cigarette Smoke and Susceptibility to Influenza Infection

Resource links provided by NLM:

MedlinePlus related topics: Flu Smoking

U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

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

Estimated Enrollment:	135
Study Start Date:	July 2006
Study Completion Date:	September 2011
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

smokers
nonsmokers who are NOT exposed to SHS

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00448617

Locations

United States, North Carolina
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

More Information

Additional Information:

University of North Carolina Center for Environmental Medicine, Asthma and Lung Biology This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Terry Noah, MD, Professor of Pediatrics, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00448617 History of Changes
Other Study ID Numbers:	05-PED-1094
Study First Received:	March 15, 2007
Last Updated:	October 5, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:

live attenuated influenza virus
inflammation
flu vaccine
FluMist
smokers

Additional relevant MeSH terms:

Disease Susceptibility
Genetic Predisposition to Disease
Influenza, Human
Disease Attributes
Pathologic Processes

Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 09, 2012