Smoke ExposurePhase 4SmokeyFluNCT06841913
Woodsmoke Exposure, Influenza Infection, and Nasal Immunity
A Phase 4 study testing LAIV nasal vaccine is chosen as a model viral infection and Wood smoke in people with Smoke Exposure and Influenza, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoke Exposure, Influenza
- What is being tested?
- LAIV nasal vaccine is chosen as a model viral infection and Wood smoke
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2025to 31 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chris Brooks contact
United States1 site, 1 recruiting
- Recruiting
Mary Ellen Jones
Chapel Hill, North Carolina, 27599
About this study
Official title: The Effects of Woodsmoke Exposure on Nasal Immune Responses to Influenza Infection in Normal Human Volunteers
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.
Read the 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
- Being tested
- 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)
- Keywords
- LAIV, Flumist, Influenza, Wood Smoke, Smoke, Fire
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAIV nasal vaccine is chosen as a model viral infectionBiological
Also called Live Attenuated Influenza Vaccine, Flumist
Inoculation with LAIV
Wood smokeOther
Wood smoke exposure concentrations at 500 ug/m3 for two hours.
Placebo for LAIV nasal vaccine is chosen as a model viral infectionBiological
Placebo for LAIV inoculation. Nasal administration of normal saline.
Placebo for Wood Smoke (clean Air Exposure)Other
Clean Air Exposure for 2 hours
| Study group | Role | What they receive |
|---|---|---|
| Wood smoke followed by LAIV | Experimental | Participants will receive LAIV after a 2 hour wood smoke exposure. Receives: Biological: LAIV nasal vaccine is chosen as a model viral infection; Other: Wood smoke |
| Wood smoke followed by Placebo | Active comparator | Participants will receive a LAIV placebo after a 2 hour wood smoke exposure. Receives: Other: Wood smoke; Biological: Placebo for LAIV nasal vaccine is chosen as a model viral infection |
| Clean Air followed by LAIV | Active comparator | Participants will receive LAIV after a 2 hour clean air exposure. Receives: Biological: LAIV nasal vaccine is chosen as a model viral infection; Other: Placebo for Wood Smoke (clean Air Exposure) |
| Clean Air followed by Placebo | Placebo comparator | Participants will receive a LAIV placebo after a 2 hour clean air exposure. Receives: Biological: Placebo for LAIV nasal vaccine is chosen as a model viral infection; Other: Placebo for Wood Smoke (clean Air Exposure) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal Mucosal secretome (AUC)
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.
Measured: Day 0 to Day 7
Gene Expression (AUC)
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.
Measured: Day 0 to Day 7
Virus Quantity (AUC)
Virus quantity in nasal secretions
Measured: Day 0 to Day 7
Nasal Neutrophils (AUC)
nasal secretion
Measured: Day 0 to Day 7
Nasal Viral Antibodies (AUC)
virus-specific antibody levels in nasal secretions
Measured: Day 0 to Day 7
Blood Viral Antibodies (AUC)
virus-specific antibody levels in blood
Measured: Day 0 to Day 7
Secondary outcomes (14)
Peak Tissue gene expression
Peak value of Tissue-level gene expression (genes identified as responsive to WS and/or LAIV)
Measured: Day 0 to Day 21
Peak nasal secretome
Peak Analysis value of the nasal mucosal secretome (secreted factors identified as responsive to WS and/or LAIV)
Measured: Day 0 to Day 21
Peak Nasal Virus quantity
Peak value of Virus quantity in nasal secretions
Measured: Day 0 to day 21
Peak nasal neutrophils
Peak value of nasal neutrophils
Measured: Day 0 to Day 21
Peak Nasal virus anti-bodies
Peak value of virus-specific antibody levels in nasal secretions
Measured: Day 0 to Day 21
Peak blood virus anti-bodies
Peak value of virus-specific antibody levels in blood
Measured: Day 0 to Day 21
Peak Day of Tissue Gene Expression
Peak Day of Tissue-level gene expression (genes identified as responsive to WS and/or LAIV)
Measured: Day 0 to Day 21
Peak Day of nasal secretome
Peak Analysis Day of the nasal mucosal secretome (secreted factors identified as responsive to WS and/or LAIV)
Measured: Day 0 to Day 21
Peak Day of Nasal Virus quantity
Peak Day of Virus quantity in nasal secretions
Measured: Day 0 to day 21
Peak Day of nasal neutrophils
Peak Day of nasal secretion
Measured: Day 0 to Day 21
Peak Day of Nasal virus anti-bodies
Peak day of virus-specific antibody levels in nasal secretions
Measured: Day 0 to Day 21
Peak Day of blood virus anti-bodies
Peak Day of virus-specific antibody levels in blood
Measured: Day 0 to Day 21
Peak Symptom score
Flu symptom questionnaire. A score from 0-18 will be recorded. Zero being symptom free and 18 the most symptomatic.
Measured: Day 0-21
Peak day of symptom score
Flu symptom questionnaire. A score from 0-18 will be recorded. Zero being symptom free and 18 the most symptomatic. The day in which there is the highest score will be recorded.
Measured: Day 0-21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start26 Sep 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoke ExposureStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 25% of participants (N=100 total for the study) will undergo each of the following. Wood smoke followed by LAIV (N=25) Wood smoke followed by Placebo (N=25) Clean Air followed by LAIV (N=25) Clean Air followed by Placebo (N=25) Males and females will be equally enrolled into each of the above cohorts.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Sponsor
- Investigators
- Meghan Rebuli, PhD, Principal investigator, UNCTerry Noah, MD, Principal investigator, UNC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841913
- Sponsor's protocol ID
- 24-1802
- Other IDs
- 1R01ES036209-01
- Acronym
- SmokeyFlu
- Status last verified
- Apr 2026
- First submitted
- 17 Feb 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Primary and Secondary Outcomes data.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Woodsmoke Exposure on Nasal Immune Responses to Influenza Infection in Normal Human Volunteers
- ClinicalTrials.gov ID
- NCT06841913
- Acronym / sponsor ID
- SmokeyFlu / 24-1802
- Conditions
- Smoke Exposure, Influenza
- Keywords
- LAIV, Flumist, Influenza, Wood Smoke, Smoke, Fire
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Environmental Health Sciences (NIEHS)
- Study start
- 26 Sep 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- 25% of participants (N=100 total for the study) will undergo each of the following. Wood smoke followed by LAIV (N=25) Wood smoke followed by Placebo (N=25) Clean Air followed by LAIV (N=25) Clean Air followed by Placebo (N=25) Males and females will be equally enrolled into each of the above cohorts.
| Arm | Type | Receives |
|---|---|---|
| Wood smoke followed by LAIV | Experimental | Biological: LAIV nasal vaccine is chosen as a model viral infection, Other: Wood smokeParticipants will receive LAIV after a 2 hour wood smoke exposure. |
| Wood smoke followed by Placebo | Active comparator | Other: Wood smoke, Biological: Placebo for LAIV nasal vaccine is chosen as a model viral infectionParticipants will receive a LAIV placebo after a 2 hour wood smoke exposure. |
| Clean Air followed by LAIV | Active comparator | Biological: LAIV nasal vaccine is chosen as a model viral infection, Other: Placebo for Wood Smoke (clean Air Exposure)Participants will receive LAIV after a 2 hour clean air exposure. |
| Clean Air followed by Placebo | Placebo comparator | Biological: Placebo for LAIV nasal vaccine is chosen as a model viral infection, Other: Placebo for Wood Smoke (clean Air Exposure)Participants will receive a LAIV placebo after a 2 hour clean air exposure. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAIV nasal vaccine is chosen as a model viral infectionAlso: Live Attenuated Influenza Vaccine, FlumistInoculation with LAIV | Biological | Clean Air followed by LAIV, Wood smoke followed by LAIV |
| Wood smokeWood smoke exposure concentrations at 500 ug/m3 for two hours. | Other | Wood smoke followed by LAIV, Wood smoke followed by Placebo |
| Placebo for LAIV nasal vaccine is chosen as a model viral infectionPlacebo for LAIV inoculation. Nasal administration of normal saline. | Biological | Clean Air followed by Placebo, Wood smoke followed by Placebo |
| Placebo for Wood Smoke (clean Air Exposure)Clean Air Exposure for 2 hours | Other | Clean Air followed by LAIV, Clean Air followed by Placebo |
Primary outcome
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
14 secondary outcomes
Peak Tissue gene expression
Time frame: Day 0 to Day 21
Peak nasal secretome
Time frame: Day 0 to Day 21
Peak Nasal Virus quantity
Time frame: Day 0 to day 21
Peak nasal neutrophils
Time frame: Day 0 to Day 21
Peak Nasal virus anti-bodies
Time frame: Day 0 to Day 21
Peak blood virus anti-bodies
Time frame: Day 0 to Day 21
Peak Day of Tissue Gene Expression
Time frame: Day 0 to Day 21
Peak Day of nasal secretome
Time frame: Day 0 to Day 21
Peak Day of Nasal Virus quantity
Time frame: Day 0 to day 21
Peak Day of nasal neutrophils
Time frame: Day 0 to Day 21
Peak Day of Nasal virus anti-bodies
Time frame: Day 0 to Day 21
Peak Day of blood virus anti-bodies
Time frame: Day 0 to Day 21
Peak Symptom score
Time frame: Day 0-21
Peak day of symptom score
Time frame: Day 0-21
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: Yes. Primary and Secondary Outcomes data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chris Brooks contact
Meghan Rebuli, PhD principal investigator
UNC
Terry Noah, MD principal investigator
UNC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing LAIV nasal vaccine is chosen as a model viral infection and Wood smoke in people with Smoke Exposure and Influenza, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carole Robinette, MS (919 966-5638, carole_robinette@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal Mucosal secretome (AUC) (time frame: Day 0 to Day 7). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.