Woodsmoke Exposure for Smoke Inhalation

(SmokeyFlu Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Terry Noah, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of North Carolina, Chapel Hill

Prior Safety Data

Trial Summary

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)

Treatment Details

Interventions

• LAIV nasal vaccine (Virus Therapy)
• Wood smoke (Other)

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+

Dr. Peggy P. McNaull

University of North Carolina, Chapel Hill

Chief Medical Officer

MD from Louisiana State University School of Medicine

Dr. Lynne Fiscus

University of North Carolina, Chapel Hill

Chief Executive Officer since 2020

MD from Georgetown University, MPH from UNC

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Dr. Jeanne Marrazzo

National Institutes of Health (NIH)

Chief Medical Officer

MD from University of California, Los Angeles

Dr. Jay Bhattacharya

National Institutes of Health (NIH)

Chief Executive Officer

MD, PhD from Stanford University

National Institute of Environmental Health Sciences (NIEHS)

Collaborator

Trials

294

Recruited

1,233,000+

Dr. Richard Woychik

National Institute of Environmental Health Sciences (NIEHS)

Chief Executive Officer since 2020

PhD in Molecular Biology from Case Western Reserve University

Dr. Ana Navas-Acien

National Institute of Environmental Health Sciences (NIEHS)

Chief Medical Officer

MD from the University of Granada, PhD in Epidemiology from Johns Hopkins Bloomberg School of Public Health