Cigarette Smoke and Susceptibility to Influenza Infection

NCT ID: NCT00448617

Last Updated: 2015-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

138 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-07-31

Study Completion Date

2011-09-30

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hamner Institutes for Health Sciences

UNKNOWN

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Terry Noah, MD

Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Terry Noah, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina at Chapel Hill, Dept of Pediatrics / Center for Environmental Medicine, Asthma and Lung Biology

Locations

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UNC Center for Environmental Medicine, Asthma and Lung Biology

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Related Links

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http://www.med.unc.edu/cemalb/

University of North Carolina Center for Environmental Medicine, Asthma and Lung Biology

Other Identifiers

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05-PED-1094

Identifier Type: -

Identifier Source: org_study_id

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