NCT06841913 · University of North Carolina, Chapel Hill
Woodsmoke Exposure, Influenza Infection, and Nasal Immunity
(SmokeyFlu)
What this study is about
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.
View original scientific 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 in Live Attenuated Influenza Virus (LAIV) -induced nasal symptoms, and reduces mucosal antibody production.
Interventions
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
Primary outcome measures
Nasal Mucosal secretome (AUC)
Time frame: Day 0 to Day 7
Analysis of the nasal mucosal secretome (secreted factors identified as responsive to WS and/or LAIV). Area under the curve (AUC) will be calculated for each proteomic profile. Descriptive statistics (means and standard deviations) will be computed for outcomes of interest (AUCs), assuming normal distribution as in previous studies.
Gene Expression (AUC)
Time frame: Day 0 to Day 7
Tissue-level gene expression (genes identified as responsive to WS and/or LAIV) and assessed for: tissue-level gene expression and untargeted metabolomic and proteomic profiles. Area under the curve (AUC) will be calculated for each gene profile. Descriptive statistics (means and standard deviations) will be computed for outcomes of interest (AUCs), assuming normal distribution as in previous studies.
Virus Quantity (AUC)
Time frame: Day 0 to Day 7
Virus quantity in nasal secretions
Nasal Neutrophils (AUC)
Time frame: Day 0 to Day 7
nasal secretion
Nasal Viral Antibodies (AUC)
Time frame: Day 0 to Day 7
virus-specific antibody levels in nasal secretions
Blood Viral Antibodies (AUC)
Time frame: Day 0 to Day 7
virus-specific antibody levels in blood
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Chapel Hill, North Carolina
Collaborators
National Institutes of Health (NIH), National Institute of Environmental Health Sciences (NIEHS)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 30, 2026 · Source of record for eligibility and locations