Cigarette Smoke and Susceptibility to Influenza Infection

This study has been completed.
Sponsor:
Collaborators:
Hamner Institutes for Health Sciences
Information provided by (Responsible Party):
Terry Noah, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00448617
First received: March 15, 2007
Last updated: October 5, 2011
Last verified: October 2011
  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:


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
  1. smokers
  2. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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:
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
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 July 20, 2014