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NCT02019745 · ClinicalTrials.gov registry record

Effects of Tobacco Products on Live Attenuated Influenza Virus (LAIV) Infections in Human Volunteers

A clinical trial, sponsored by University of North Carolina, Chapel Hill.

Completed
Registry status
62
Enrollment target

NCT02019745 is a clinical trial that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 62 participants.

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The verdict

NCT02019745 has completed, sponsored by University of North Carolina, Chapel Hill.

COMPLETED
Registry status
62 participants
Enrollment target

Study Summary

Chronic exposure to (cigarette smoke) CS causes biological changes, including airway remodeling and changes in baseline gene expression profiles at the level of the epithelium. Our own data indicate that chronic exposure to CS suppresses the ability of epithelial cells to enhance antiviral gene expression in response to influenza infection and activate host defense responses. While there is a large body of evidence supporting the notion that exposure to CS causes significant changes in host defense responses, which may be linked to permanent changes in epithelial cells at the genomic level, it is not known whether new and emerging tobacco products have similar or distinct effects. Using live attenuated influenza virus (LAIV) inoculation in human volunteers, this study will compare influenza-induced responses in non-smokers (NS), cigarette smokers (CS), e-cigarette smokers (EC), hookah smokers (HS), and Little Cigar smokers (LCS) in vivo. This will be done by analyzing nasal viral titers, antiviral defense responses, inflammatory mediator production, and markers of immune responses for LAIV-induced responses between the different groups of volunteers.

Interventions

  • BIOLOGICAL LAIV

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2014-06
Est. Completion 2016-06

What the Registry Record Tells You About NCT02019745

The ClinicalTrials.gov registry entry for NCT02019745 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which LAIV is the first listed.

NCT02019745 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02019745 about?

NCT02019745 is a clinical study titled "Effects of Tobacco Products on Live Attenuated Influenza Virus (LAIV) Infections in Human Volunteers". Chronic exposure to (cigarette smoke) CS causes biological changes, including airway remodeling and changes in baseline gene expression profiles at the level of the epithelium. Our own data indicate that chronic exposure to CS suppresses the ability of epithelial cells to enhance antiviral gene expr...

What is the current status of trial NCT02019745?

This trial is currently completed. The enrollment target is 62 participants. The study started on 2014-06. Estimated completion is 2016-06.

What interventions are being tested in trial NCT02019745?

The interventions under investigation include: LAIV (BIOLOGICAL).

Who is sponsoring clinical trial NCT02019745?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.