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OpenTrials
Completed

NCT Number: NCT00448617

Cigarette Smoke and Susceptibility to Influenza Infection

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

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UNC Center for Environmental Medicine, Asthma and Lung Biology

Chapel Hill, North Carolina, 27599-7310, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Hamner Institutes for Health Sciences
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Mar 19, 2007
Registry last updated
May 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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