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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: Completed study, sponsored by University of North Carolina, Chapel Hill.
NCT02019745 is a clinical trial that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 62 participants. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Influenza hemagglutinin (HA) messenger ribonucleic acid (mRNA) (normalized to β-actin) will be measured in nasal lavage fluid (NLF) cells from NS, CS, EC, HS, and LCS by quantitative real time-polymerase chain reaction (qRT-PCR) after LAIV inoculation.
Interventions
- BIOLOGICAL LAIV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2014-06 |
| Est. Completion | 2016-06 |
What the finished NCT02019745 record still lists
NCT02019745 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 62 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which LAIV is the first listed.
NCT02019745 does not publish any study locations in the registry export this page uses.
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.
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