Woodsmoke Exposure, Influenza Infection, and Nasal Immunity
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-49
SponsorUniversity of North Carolina, Chapel Hill
About this trial
This study will investigate the effects of woodsmoke (WS) exposure on human nasal mucosal immune responses to viral infection. The study tests the hypotheses that WS exposure modifies biomarkers of nasal mucosal immune function, increases in Live Attenuated Influenza Virus (LAIV) -induced nasal symptoms, and reduces mucosal antibody production.
Eligibility criteria
Qualifiers
Normal lung function,
oxygen saturation of >94%,
normal blood pressure,
no respiratory symptoms on history, no abnormalities on exam, normal pulmonary function testing,
Disqualifiers
A history of significant chronic illnesses (to include diabetes, autoimmune diseases, immunodeficiency state, known ischemic heart disease, chronic respiratory diseases such as chronic obstructive pulmonary disease or asthma, hypertension)
Positive pregnancy test within 48 hours of the time of challenge
Use of any inhaled substance (for medical or recreational purposes).
Nonsmokers must have been abstinent from smoking for the prior 12 months, having not smoked more than 1 pack over the course of the previous year.
Trial design
Treatments tested in this trial
- LAIV nasal vaccine is chosen as a model viral infection
- Wood smoke
- Placebo for LAIV nasal vaccine is chosen as a model viral infection
- Placebo for Wood Smoke (clean Air Exposure)
Treatment groups
112 Participants
are divided into 4 treatment groupsSponsors and collaborators
University of North Carolina, Chapel Hill
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute of Environmental Health Sciences (NIEHS)
Collaborator
Source ClinicalTrials.gov