PM exposure for Air Pollution

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Air PollutionPM exposure - Other
Eligibility
18 - 35
All Sexes
What conditions do you have?
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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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 8 Secondary · Reporting Duration: Four days

Four days
Ambulatory ECG will be measured 2 hours before each PM exposure day and follow up day in 20 subjects
Ambulatory ECG will be measured 2 hours before each air exposure day and follow up 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
Blood inflammation marker, CRP, will be measured 2 hours before each air exposure day and follow up day in 20 subjects
Spirometry will be measured 1 hour before each PM exposure day and follow up day in 20 subjects
Spirometry will be measured 1 hour before each air exposure day and follow up day in 20 subjects
Three days
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
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
Spirometry will be measured 1 hour after each PM exposure day in 20 subjects
Spirometry will be measured 1 hour after each air exposure day in 20 subjects

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

PM exposure
1 of 2
Filtered air exposure
1 of 2

Experimental Treatment

20 Total Participants · 2 Treatment Groups

Primary Treatment: PM exposure · No Placebo Group · N/A

PM exposure
Other
Experimental Group · 1 Intervention: PM exposure · Intervention Types: Other
Filtered air exposure
Other
Experimental Group · 1 Intervention: Filtered air exposure · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: four days

Who is running the clinical trial?

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

Eligibility Criteria

Age 18 - 35 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a ratio of your FEV1/FVC of 80% or higher.
You are between the ages of 18 and 35 years old and are healthy.
You have normal lung function based on NHANES III reference values.