NCT06841913 Woodsmoke Exposure, Influenza Infection, and Nasal Immunity
| NCT ID | NCT06841913 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Smoke Exposure |
| Study Type | INTERVENTIONAL |
| Enrollment | 112 participants |
| Start Date | 2025-09-26 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 112 participants in total. It began in 2025-09-26 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Normal lung function, * oxygen saturation of \>94%, * normal blood pressure, * no respiratory symptoms on history, no abnormalities on exam, normal pulmonary function testing, * 18-49 Years of age. Exclusion Criteria: * 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. * History of allergy to eggs * Acute, non-chronic, medical conditions, including (but not limited to) pneumonia or bronchitis requiring antibiotics, febrile illnesses, flu-like symptoms must be totally resolved symptomatically for 3 weeks * Unspecified illnesses, which in the judgment of the investigator increase the risk associated with the experimental LAIV infection, will be a basis for exclusion. * Expected exposure of subject to immunocompromised individuals (who can be infected by LAIV) for the 3 weeks following LAIV inoculation. * Use of immunosuppressive drugs within the past 6 months. * Previous Woodsmoke exposure \<3 weeks, which is considered to an appropriate washout period
Contact & Investigator
Meghan Rebuli, PhD
PRINCIPAL INVESTIGATOR
UNC
Frequently Asked Questions
Who can join the NCT06841913 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 49 Years, studying Smoke Exposure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06841913 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06841913 currently recruiting?
Yes, NCT06841913 is actively recruiting participants. Contact the research team at carole_robinette@med.unc.edu for enrollment information.
Where is the NCT06841913 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT06841913 clinical trial?
NCT06841913 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Meghan Rebuli, PhD at UNC. The trial plans to enroll 112 participants.