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Wood Smoke Exposure for Healthy Subjects (MASKOFF Trial)

N/A
Recruiting
Led By James Samet, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Forced vital capacity (FVC) equal to or greater than 80 % of that predicted for age, gender, ethnicity, and height.
Forced expiratory volume in one second (FEV1) equal to or greater than 80% of that predicted for age, gender, ethnicity, and height.
Must not have
Individuals who are currently taking systemic steroids or oral anticoagulants long term
Individuals who are currently smoking (including vaping, hookah and e-cigarette) or have smoking history within 1 year of study or have an equal to greater than or a 5-pack year smoking history
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 2, day 3, day 4, day 5

Summary

This trial is designed to study the cardiovascular effects of wood smoke exposure in young, healthy subjects. Approximately 80 subjects will be exposed to filtered air and wood smoke, and sputum samples will be collected 4 hours post exposure.

Who is the study for?
This trial is for healthy adults aged 18-35 with a BMI of 19-30, normal lung and heart function, up-to-date COVID vaccinations, and the ability to do mild exercise. It's not for those on long-term steroids or blood thinners, with high blood pressure or diabetes, cardiovascular risks over 10%, recent surgeries, certain medication use, pregnancy/breastfeeding status, smokers (including recent history), non-English speakers who can't consent properly.
What is being tested?
The MASKOFF study examines how wood smoke affects the heart and lungs in healthy young adults. Participants will breathe filtered air then wood smoke during two separate sessions involving rest and exercise intervals while their blood samples are taken along with lung and heart measurements before and after exposure.
What are the potential side effects?
While specific side effects aren't listed as it's an observational study on healthy individuals exposed to wood smoke versus filtered air; potential side effects may include respiratory irritation or temporary changes in lung function due to inhaling particulate matter.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung function is at least 80% of the expected level for someone my age, gender, ethnicity, and height.
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My lung function, measured by FEV1, is within the normal range for my age, gender, ethnicity, and height.
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I am between 18 and 35 years old, healthy, and my BMI is between 19 and 30.
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I am between 18 and 35 years old with a BMI between 19 and 30.
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I can do light exercise for 2 hours and handle a specific breathing exercise without my heart rate going too high.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently on long-term steroids or blood thinners.
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I currently smoke or have smoked within the last year.
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I have a bleeding or clotting disorder.
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I have diabetes or my A1c level is 6.4% or higher.
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I have not had recent surgery or any condition that increases pressure in my abdomen.
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I have a history of heart, lung, cancer, joint, muscle, or immune system diseases.
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I am currently taking prebiotics, probiotics, or antihistamines.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 2, day 3, day 4, day 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 2, day 3, day 4, day 5 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in polymorphonuclear neutrophils (PMN%) in the Sputum
Secondary study objectives
Change in Blood Cholesterol (ng/mL)
Change in Blood Fatty Acids (ng/mL)
Change in C-reactive protein in blood. (mg/dL)
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Wood SmokeExperimental Treatment1 Intervention
Subjects will be exposed to air containing wood smoke for 2 hours with alternating 15 minutes of exercise (cycle ergometer) and rest.
Group II: Filtered airPlacebo Group1 Intervention
Subjects will be exposed once to filtered air for 2 hours with alternating 15 minutes of exercise (cycle ergometer) and rest.

Find a Location

Who is running the clinical trial?

Environmental Protection Agency (EPA)FED
39 Previous Clinical Trials
95,357 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,554 Previous Clinical Trials
4,293,053 Total Patients Enrolled
James Samet, PhDPrincipal InvestigatorEnvironmental Protection Agency (EPA)
3 Previous Clinical Trials
644 Total Patients Enrolled
~37 spots leftby Dec 2027
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