NCT06841913

Woodsmoke Exposure, Influenza Infection, and Nasal Immunity

The Effects of Woodsmoke Exposure on Nasal Immune Responses to Influenza Infection in Normal Human Volunteers

• Status: Suspended
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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 LAIV-induced nasal symptoms, and reduces mucosal antibody production. Healthy volunteers will be randomized for a 2-hr exposure to WS or placebo (filtered air) and then inoculated with either live attenuated influenza virus (LAIV) or placebo. Nasal mucosal samples, symptoms, and peripheral blood will be collected on days 1,2,3,7, and 21 post-exposure/LAIV and assessed for a) mucosal antiviral responses using targeted and non-targeted analysis of the secretome and tissue-level gene expression; b) symptoms, virus quantity, differential cell count, and virus-specific antibody levels; and c) biomarker signatures associated with infection outcomes using computational modeling tools.

Conditions

• Smoke Exposure
• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	LAIV nasal vaccine is chosen as a model viral infection	Inoculation with LAIV
OTHER	Wood smoke	Wood smoke exposure concentrations at 500 ug/m3 for two hours.
BIOLOGICAL	Placebo for LAIV nasal vaccine is chosen as a model viral infection	Placebo for LAIV inoculation. Nasal administration of normal saline.
OTHER	Placebo for Wood Smoke (clean Air Exposure)	Clean Air Exposure for 2 hours

Timeline

• Start date: 2026-10-01
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2025-02-24
• Last updated: 2025-06-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study