Woodsmoke Exposure, Influenza Infection, and Nasal Immunity (SmokeyFlu)

April 24, 2026 updated by: University of North Carolina, Chapel Hill

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
112

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • Mary Ellen Jones

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Wood smoke followed by LAIV
Participants will receive LAIV after a 2 hour wood smoke exposure.
Biological: LAIV nasal vaccine is chosen as a model viral infection
Inoculation with LAIV
Other Names:
  • Flumist
  • Live Attenuated Influenza Vaccine
Other: Wood smoke
Wood smoke exposure concentrations at 500 ug/m3 for two hours.
Active Comparator: Wood smoke followed by Placebo
Participants will receive a LAIV placebo after a 2 hour wood smoke exposure.
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.
Active Comparator: Clean Air followed by LAIV
Participants will receive LAIV after a 2 hour clean air exposure.
Biological: LAIV nasal vaccine is chosen as a model viral infection
Inoculation with LAIV
Other Names:
  • Flumist
  • Live Attenuated Influenza Vaccine
Other: Placebo for Wood Smoke (clean Air Exposure)
Clean Air Exposure for 2 hours
Placebo Comparator: Clean Air followed by Placebo
Participants will receive a LAIV placebo after a 2 hour clean air exposure.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day 0 to Day 7
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.
Day 0 to Day 7
Virus Quantity (AUC)
Time Frame: Day 0 to Day 7
Virus quantity in nasal secretions
Day 0 to Day 7
Nasal Neutrophils (AUC)
Time Frame: Day 0 to Day 7
nasal secretion
Day 0 to Day 7
Nasal Viral Antibodies (AUC)
Time Frame: Day 0 to Day 7
virus-specific antibody levels in nasal secretions
Day 0 to Day 7
Blood Viral Antibodies (AUC)
Time Frame: Day 0 to Day 7
virus-specific antibody levels in blood
Day 0 to Day 7

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Peak Tissue gene expression
Time Frame: Day 0 to Day 21
Peak value of Tissue-level gene expression (genes identified as responsive to WS and/or LAIV)
Day 0 to Day 21
Peak nasal secretome
Time Frame: Day 0 to Day 21
Peak Analysis value of the nasal mucosal secretome (secreted factors identified as responsive to WS and/or LAIV)
Day 0 to Day 21
Peak Nasal Virus quantity
Time Frame: Day 0 to day 21
Peak value of Virus quantity in nasal secretions
Day 0 to day 21
Peak nasal neutrophils
Time Frame: Day 0 to Day 21
Peak value of nasal neutrophils
Day 0 to Day 21
Peak Nasal virus anti-bodies
Time Frame: Day 0 to Day 21
Peak value of virus-specific antibody levels in nasal secretions
Day 0 to Day 21
Peak blood virus anti-bodies
Time Frame: Day 0 to Day 21
Peak value of virus-specific antibody levels in blood
Day 0 to Day 21
Peak Day of Tissue Gene Expression
Time Frame: Day 0 to Day 21
Peak Day of Tissue-level gene expression (genes identified as responsive to WS and/or LAIV)
Day 0 to Day 21
Peak Day of nasal secretome
Time Frame: Day 0 to Day 21
Peak Analysis Day of the nasal mucosal secretome (secreted factors identified as responsive to WS and/or LAIV)
Day 0 to Day 21
Peak Day of Nasal Virus quantity
Time Frame: Day 0 to day 21
Peak Day of Virus quantity in nasal secretions
Day 0 to day 21
Peak Day of nasal neutrophils
Time Frame: Day 0 to Day 21
Peak Day of nasal secretion
Day 0 to Day 21
Peak Day of Nasal virus anti-bodies
Time Frame: Day 0 to Day 21
Peak day of virus-specific antibody levels in nasal secretions
Day 0 to Day 21
Peak Day of blood virus anti-bodies
Time Frame: Day 0 to Day 21
Peak Day of virus-specific antibody levels in blood
Day 0 to Day 21
Peak Symptom score
Time Frame: Day 0-21
Flu symptom questionnaire. A score from 0-18 will be recorded. Zero being symptom free and 18 the most symptomatic.
Day 0-21
Peak day of symptom score
Time Frame: Day 0-21
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.
Day 0-21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)
National Institute of Environmental Health Sciences (NIEHS)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Meghan Rebuli, PhD, UNC
  • Principal Investigator: Terry Noah, MD, UNC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 26, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24-1802
  • 1R01ES036209-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Primary and Secondary Outcomes data.

IPD Sharing Time Frame

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication.

IPD Sharing Access Criteria

The investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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