Cigarette Smoke and Susceptibility to Influenza Infection

Healthy Clinical Trial

Official title:

Cigarette Smoke and Susceptibility to Influenza Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00448617
• Other study ID #: 05-PED-1094
• Status: Completed
• Phase: N/A
• First received: March 15, 2007
• Last updated: May 28, 2015
• Start date: July 2006
• Est. completion date: September 2011

Study information

• Verified date: May 2015
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Disease Susceptibility
• Healthy

Locations

Country	Name	City	State
United States	UNC Center for Environmental Medicine, Asthma and Lung Biology	Chapel Hill	North Carolina

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal responses of healthy adult volunteers not routinely exposed to SHS vs responses of smokers, to live attenuated influenza virus.		5-8-weeks	No
Secondary	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	No
Secondary	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	No

External Links

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