Cigarette Smoke and Susceptibility to Influenza Infection

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00448617

Enrollment

138

Registered

2007-03-19

Start date

2006-07-31

Completion date

2011-09-30

Last updated

2015-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

live attenuated influenza virus, inflammation, flu vaccine, FluMist, smokers

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 35 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

United States

Outcome results