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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study how woodsmoke exposure affects the immune response in the nose during a viral infection. Researchers seek to determine if inhaling woodsmoke alters certain immune markers, worsens symptoms from a nasal flu vaccine (LAIV nasal vaccine), and reduces antibody production in the nose. Participants will be exposed to either woodsmoke or clean air and then receive either the nasal flu vaccine or a placebo. Ideal candidates have normal lung function, no respiratory symptoms, and have smoked no more than one pack of cigarettes in the past year. As a Phase 4 trial, this research focuses on understanding how the FDA-approved nasal flu vaccine can benefit more patients.

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 is the safety track record for these treatments?

Studies have shown that the nasal flu vaccine, known as the Live Attenuated Influenza Virus (LAIV) vaccine, is generally safe and well-tolerated. Research indicates that exposure to wood smoke does not significantly alter the body's response to the LAIV vaccine. Most recipients experience only mild symptoms, such as a runny nose or sore throat, which typically resolve on their own.

Previous research suggests that wood smoke might affect men and women differently, but these differences do not appear to cause serious issues when combined with the LAIV vaccine. Overall, the vaccine is considered safe, even for those exposed to wood smoke. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the trial exploring the use of the LAIV nasal vaccine for smoke inhalation because it uses an innovative delivery method that may offer quicker protection compared to traditional treatments. Unlike standard therapies that often involve oxygen therapy or medications to reduce inflammation, the LAIV nasal vaccine is delivered directly to the respiratory system, potentially enhancing its effectiveness against respiratory issues caused by wood smoke exposure. This method could offer a novel way to protect or mitigate lung damage quickly, providing a new avenue for treatment that standard care options don't currently address.

What evidence suggests that this trial's treatments could be effective for smoke inhalation?

This trial will compare the effects of wood smoke exposure on the effectiveness of the Live Attenuated Influenza Vaccine (LAIV). Research has shown that LAIV effectively helps the body fight viruses by creating strong defenses and limiting viral growth. Participants in this trial will be exposed to either wood smoke or clean air before receiving LAIV or a placebo. Studies indicate that wood smoke exposure doesn't significantly affect LAIV's effectiveness. While smoke might slightly alter the body's immune response, it doesn't reduce the vaccine's overall effectiveness. Overall, LAIV is considered a reliable choice for flu protection. ^{1 2 3 6 7}

Who Is on the Research Team?

Terry Noah, MD

Principal Investigator

UNC

Meghan Rebuli, PhD

Principal Investigator

UNC

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6467301/

Wood Smoke Exposure Alters Human Inflammatory ... No effect of WSP exposure on response to LAIV in aggregate gene expression data was found; none of the genes examined reached statistical significance (see ...

2. ctv.veeva.com ctv.veeva.com/study/woodsmoke-exposure-influenza-infection-and-nasal-immunity

Woodsmoke Exposure, Influenza Infection, and Nasal Immunity This study will investigate the effects of woodsmoke (WS) exposure on human nasal mucosal immune responses to viral infection.

3. withpower.com withpower.com/trial/phase-4-influenza-human-2-2025-f7551

Woodsmoke Exposure for Smoke Inhalation This study will investigate the effects of woodsmoke (WS) exposure on human nasal mucosal immune responses to viral infection.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30360637/

Wood Smoke Exposure Alters Human Inflammatory ... - PubMed Conclusions: WSP exposure resulted in minimal modification of LAIV-induced responses in aggregate analysis. In contrast, analyzing WSP-induced ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0264410X17313063

Evaluation of the innate immune responses to influenza ... We demonstrate that LAIV elicits robust antiviral responses, which may also restrict viral replication. LAIV also induces enhanced chemokine ...

6. researchgate.net researchgate.net/publication/328538650_Wood_Smoke_Exposure_Alters_Human_Inflammatory_Responses_to_Viral_Infection_in_a_Sex-Specific_Manner_A_Randomized_Placebo-Controlled_Study

Wood Smoke Exposure Alters Human Inflammatory ... This is corroborated by a randomised, parallel-group, controlled-exposure study which revealed that wood smoke showed sex-specific effects on ...

7. sciencedaily.com sciencedaily.com/releases/2018/10/181026083024.htm

When it comes to respiratory effects of wood smoke, sex ... Exposure to wood smoke can have different effects on the respiratory immune systems of men and women -- effects that may be obscured when ...