Woodsmoke Exposure for Smoke Inhalation

(SmokeyFlu Trial)

Overseen By Carole Robinette, MS

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Immunosuppressive drugs

Disqualifiers: Diabetes, Autoimmune diseases, Asthma, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

112 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who have used immunosuppressive drugs in the past 6 months.

What data supports the effectiveness of the treatment LAIV nasal vaccine, Wood smoke for smoke inhalation?

Research on mice suggests that exposure to wood smoke particles can improve the body's response to influenza infection, leading to better respiratory outcomes like reduced weight loss and increased blood oxygen levels. ^{1 2 3 4 5}

How does the LAIV nasal vaccine treatment differ from other treatments for smoke inhalation?

The LAIV nasal vaccine is unique because it is administered through the nose, which is different from most treatments for smoke inhalation that are typically given by mouth or injection. This vaccine is designed to stimulate the immune system in the respiratory tract, potentially offering a novel way to protect against respiratory infections that can be worsened by smoke exposure. ^{1 2 6 7 8}

What is the purpose of this trial?

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.

Research Team

Meghan Rebuli, PhD

Principal Investigator

UNC

Terry Noah, MD

Principal Investigator

UNC

Eligibility Criteria

This trial is for healthy adults aged 18-49 with normal lung function, blood pressure, and oxygen saturation. Smokers or those exposed to woodsmoke recently can't join. Pregnant individuals, people with egg allergies, recent illness, chronic conditions like diabetes or heart disease, or those on immunosuppressants are excluded.

Inclusion Criteria

Oxygen saturation of >94%

My lung function is normal.

My blood pressure is within the normal range.

Exclusion Criteria

Unspecified illnesses, which in the judgment of the investigator increase the risk associated with the experimental LAIV infection, will be a basis for exclusion

Positive pregnancy test within 48 hours of the time of challenge

Use of any inhaled substance (for medical or recreational purposes)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Exposure and Inoculation

Participants are exposed to woodsmoke or clean air for 2 hours and then inoculated with LAIV or placebo

1 day

1 visit (in-person)

Monitoring and Sample Collection

Nasal mucosal samples, symptoms, and peripheral blood are collected and assessed on days 1, 2, 3, 7, and 21 post-exposure/LAIV

3 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• LAIV nasal vaccine
• Wood smoke

Trial Overview The study examines how exposure to woodsmoke affects the body's nasal immune response when given a Live Attenuated Influenza Virus (LAIV) nasal vaccine compared to placebo treatments of both LAIV and wood smoke (clean air).

Participant Groups

Group I: Wood smoke followed by LAIV Experimental Treatment 2 Interventions

Participants will receive LAIV after a 2 hour wood smoke exposure.

Group II: Wood smoke followed by Placebo Active Control 2 Interventions

Participants will receive a LAIV placebo after a 2 hour wood smoke exposure.

Group III: Clean Air followed by LAIV Active Control 2 Interventions

Participants will receive LAIV after a 2 hour clean air exposure.

Group IV: Clean Air followed by Placebo Placebo Group 2 Interventions

Participants will receive a LAIV placebo after a 2 hour clean air exposure.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of Environmental Health Sciences (NIEHS)

Collaborator

Trials

294

Recruited

1,233,000+

Findings from Research

Sub-acute exposure to wood smoke particles (WSP) in rodents improved the host response to influenza infection, leading to reduced weight loss and increased blood oxygen saturation compared to controls.

Acute WSP exposure increased airspace macrophages, while sub-acute exposure resulted in a dose-dependent increase in neutrophils, indicating that WSP exposure can modulate immune cell responses during viral infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wood smoke particle exposure in mice reduces the severity of influenza infection. Vose, A., McCravy, M., Birukova, A., et al.[2022]

Woodsmoke contains harmful pollutants, including carcinogenic compounds like carbon monoxide (CO) and nitrogen oxides (NOx), which pose significant health risks similar to those from other combustion sources, as established by extensive research.

The review questions whether woodsmoke should be regulated separately due to its unique properties and health impacts, suggesting that further research is needed to fully understand its risks compared to other ambient particles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Woodsmoke health effects: a review. Naeher, LP., Brauer, M., Lipsett, M., et al.[2022]

Increased use of woodburning for heating in North America has led to greater public exposure to harmful woodsmoke pollutants, raising concerns about health risks, especially for children.

The review highlights a significant gap in research on the toxicological effects of woodsmoke exposure, emphasizing the need for more studies to understand its impact on health and to inform regulatory standards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The toxicology of inhaled woodsmoke. Zelikoff, JT., Chen, LC., Cohen, MD., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Exposure of wildland firefighters to carbon monoxide, fine particles, and levoglucosan. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Wood smoke particle exposure in mice reduces the severity of influenza infection. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Wildland fire smoke and human health. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Using Low-Cost Sensors to Assess Fine Particulate Matter Infiltration (PM2.5) during a Wildfire Smoke Episode at a Large Inpatient Healthcare Facility. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Smoldering and flaming biomass wood smoke inhibit respiratory responses in mice. [2021]

6. Poland pubmed.ncbi.nlm.nih.gov

Woodsmoke marker levoglucosan: kinetics in a self-experiment. [2017]

7. England pubmed.ncbi.nlm.nih.gov

Woodsmoke health effects: a review. [2022]

8. England pubmed.ncbi.nlm.nih.gov

The toxicology of inhaled woodsmoke. [2022]