← Back to Search

N/A

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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 2, day 3, day 4, day 5
Awards & highlights

MASKOFF Trial 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.Check my eligibility
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.See study design
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.

MASKOFF Trial Eligibility Criteria

Inclusion Criteria

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

MASKOFF Trial 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

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

MASKOFF 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
38 Previous Clinical Trials
94,857 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,190,962 Total Patients Enrolled
James Samet, PhDPrincipal InvestigatorEnvironmental Protection Agency (EPA)
2 Previous Clinical Trials
144 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
North Carolina
How old are they?
65+
18 - 65
What site did they apply to?
U.S. Environmental Protection Agency Human Studies Facility
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Cardiovascular Effects of Exposure to Wood Smoke in Healthy Human Adults
2021. "Cardiovascular Effects of Exposure to Wood Smoke in Healthy Human Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04297761.
~44 spots leftby Dec 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top