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PM Exposure for Air Pollution Effects

N/A
Recruiting
Research Sponsored by U.S. EPA Human Studies Facility
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Physical conditioning allowing intermittent, moderate exercise for 2 hours, and ability to complete the exposure exercise regimen to induce a minute ventilation rate of 20 L/min/m2 for 15 min without exceeding 80% of projected maximal heart rate. Predicted maximal heart rate will be calculated using the equation [described by Tanaka et al.: (2001) J. Am. Coll. Cardiol: 208bpm-((0.7) x (age in years))]
Normal lung function based on NHANES III reference values. i. Forced vital capacity (FVC) ≥ 80% of that predicted for age, gender, ethnicity, and height. ii. Forced expiratory volume in one second (FEV1) ≥ 80% of that predicted for age, gender, ethnicity, and height. iii: FEV1/FVC ratio ≥ 80% of predicted values.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three days
Awards & highlights

Study Summary

This trial will test whether exposure to levels of particulate matter that are close to the current national standard for 24-hour exposure will cause changes in inflammatory and cardiopulmonary function in healthy young people.

Who is the study for?
Healthy individuals aged 18-35 with normal lung function and heart health, not vaccinated for or recovered from COVID-19, non-smokers without chronic diseases. They must be able to exercise moderately and have a BMI between 19 and 30.Check my eligibility
What is being tested?
The trial tests the effects of breathing low levels of fine particulate matter (PM2.5) compared to filtered air on inflammation and heart/lung health in healthy young adults over three consecutive days.See study design
What are the potential side effects?
There may not be immediate side effects; however, the study is investigating potential inflammatory responses or changes in heart and lung function due to exposure to fine particles in the air.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~four days
This trial's timeline: 3 weeks for screening, Varies for treatment, and four days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blood inflammation marker, CRP, will be measured 1 hour after each PM exposure day in 20 subjects
Blood inflammation marker, CRP, will be measured 1 hour after each air exposure day in 20 subjects
Blood inflammation marker, CRP, will be measured 2 hours before each PM exposure day and follow up day in 20 subjects
+1 more
Secondary outcome measures
Ambulatory ECG will be measured 2 hours after each PM exposure day in 20 subjects
Ambulatory ECG will be measured 2 hours after each air exposure day in 20 subjects
Ambulatory ECG will be measured 2 hours before each PM exposure day and follow up day in 20 subjects
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: PM exposureExperimental Treatment1 Intervention
Subjects will be randomly exposed to three consecutive days of PM2.5 exposure arm in a double-blind cross-over fashion in an exposure chamber, and exposures will be separated by a minimum of 13 days from the filtered air arm.
Group II: Filtered air exposureExperimental Treatment1 Intervention
Subjects will be randomly exposed to three consecutive days of filtered air exposure arm in a double-blind cross-over fashion in an exposure chamber, and exposures will be separated by a minimum of 13 days from the PM2.5 arm.

Find a Location

Who is running the clinical trial?

U.S. EPA Human Studies FacilityLead Sponsor
1 Previous Clinical Trials
62 Total Patients Enrolled

Media Library

PM exposure Clinical Trial Eligibility Overview. Trial Name: NCT05323240 — N/A
Air Pollution Research Study Groups: Filtered air exposure, PM exposure
Air Pollution Clinical Trial 2023: PM exposure Highlights & Side Effects. Trial Name: NCT05323240 — N/A
PM exposure 2023 Treatment Timeline for Medical Study. Trial Name: NCT05323240 — N/A

Frequently Asked Questions

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

What is the recruitment size for this clinical trial?

"Affirmative. The information found on clinicaltrials.gov confirms that this research is presently enrolling patients. It was initially posted back in May 12th 2022 and has been revised as recently as October 31st 2022. This project seeks to recruit 20 participants from a single clinic site."

Answered by AI

Who is the ideal candidate to include in this research endeavor?

"The clinical trial is enrolling 20 participants aged 18-35 who have been exposed to air pollution. Candidates must pass a physical exam, including an electrocardiogram and pulmonary function tests, while meeting the following criteria: tolerating moderate exercise for two hours; having a forced expiratory volume in one second (FEV1) at least 80% of that predicted for age, gender, ethnicity and height; FEV1/FVC ratio greater than or equal to 80%; oxygen saturation above 94%; body mass index between 19-30; normal lung function based on NHANES III reference values and finally forcing vital capacity at"

Answered by AI

Does this trial accept individuals aged 85 and above?

"Applicants who are between the age of 18 and 35 years old meet the candidacy requirements for this trial."

Answered by AI

Are there any open slots currently available for this research study?

"Confirmed. According to the information on clinicaltrials.gov, this research project is actively enrolling participants and was posted on May 12th 2022 with an update made October 31st 2022. A total of 20 individuals are being sought out from 1 location for participation in the trial."

Answered by AI

What outcome is this research endeavor looking to accomplish?

"The primary endpoint of this study, which is to be assessed over four days, will involve the measurement of C-reactive protein (CRP) levels in 20 patients two hours before each particulate matter exposure day and followup. Secondary endpoints include Spirometry tests measuring FEV1 and FVC one hour after air exposure on Day 1, 2, and 3 for all 20 participants; a similar Spirometry test administered one hour after PM exposure on Days 1, 2 and 3; and ambulatory electrocardiography (ECG), including QT interval measurements via Holter monitor five minutes post-air exposure across all three days"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Health Effects of Repeated Exposure to Low Levels of Concentrated Ambient Particles in Healthy Young Volunteers
Haiyan Tong 2022. "Health Effects of Repeated Exposure to Low Levels of Concentrated Ambient Particles in Healthy Young Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05323240.
~1 spots leftby Jun 2024
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