Trial Outcomes & Findings for Air Pollution Study: The Effect of Ozone on the Lung (NCT NCT02673775)
NCT ID: NCT02673775
Last Updated: 2025-09-25
Results Overview
The relative concentrations of M1 and M2 macrophages in the induced sputum sample will be assessed.
COMPLETED
NA
135 participants
24 hours after exposure.
2025-09-25
Participant Flow
135 participants from the local community were screened for eligibility between 2/1/2016 and 5/4/2022.
57 were ineligible and 16 were lost to follow-up. 62 were randomized to the first exposure.
Participant milestones
| Measure |
Ozone Exposure Was First, Followed by Clean Air Exposure
Subjects randomized to ozone first and clean air second. A washout period (at least 2 weeks) took place between exposures.
|
Clean Air Exposure Was First, Followed by Ozone Exposure
Subjects randomized to clean air first and ozone second. A washout period (at least 2 weeks) took place between exposures.
|
|---|---|---|
|
First Exposure
STARTED
|
25
|
37
|
|
First Exposure
COMPLETED
|
25
|
37
|
|
First Exposure
NOT COMPLETED
|
0
|
0
|
|
Washout (at Least 2 Weeks)
STARTED
|
25
|
37
|
|
Washout (at Least 2 Weeks)
COMPLETED
|
21
|
33
|
|
Washout (at Least 2 Weeks)
NOT COMPLETED
|
4
|
4
|
|
Second Exposure
STARTED
|
21
|
33
|
|
Second Exposure
COMPLETED
|
21
|
33
|
|
Second Exposure
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Ozone Exposure Was First, Followed by Clean Air Exposure
Subjects randomized to ozone first and clean air second. A washout period (at least 2 weeks) took place between exposures.
|
Clean Air Exposure Was First, Followed by Ozone Exposure
Subjects randomized to clean air first and ozone second. A washout period (at least 2 weeks) took place between exposures.
|
|---|---|---|
|
Washout (at Least 2 Weeks)
Lost to Follow-up
|
1
|
0
|
|
Washout (at Least 2 Weeks)
Physician Decision
|
1
|
0
|
|
Washout (at Least 2 Weeks)
Withdrawal by Subject
|
0
|
2
|
|
Washout (at Least 2 Weeks)
Study paused during COVID pandemic (3/5/2020 to 9/15/2021)
|
2
|
2
|
Baseline Characteristics
Air Pollution Study: The Effect of Ozone on the Lung
Baseline characteristics by cohort
| Measure |
Overall
n=62 Participants
All participants who were randomized to a first exposure (N=62)
|
|---|---|
|
Age, Continuous
|
23.2 years
STANDARD_DEVIATION 4.8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
21 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 24 hours after exposure.Population: The number of participants who had an adequate sputum sample collected 24 hours after each exposure.
The relative concentrations of M1 and M2 macrophages in the induced sputum sample will be assessed.
Outcome measures
| Measure |
Clean Air
n=13 Participants
Subjects will be exposed to clean air for 3 hours.
Clean Air: Subjects will have the clean air exposure first, followed by the ozone exposure
|
Ozone
n=13 Participants
Subjects will be exposed to 0.2 ppm ozone for 3 hours.
Ozone: Subjects will have the ozone exposure first, followed by the clean air exposure
|
|---|---|---|
|
Concentrations of M1 and M2 Macrophages in the Sputum 24 Hours After Exposure.
|
6.823 ratio of M2 to M1 macrophages
Standard Error 2.413
|
1.367 ratio of M2 to M1 macrophages
Standard Error 0.367
|
PRIMARY outcome
Timeframe: 48 hours after exposurePopulation: The number of participants who had an adequate sputum sample collected 48 hours after each exposure.
The relative concentrations of M1 and M2 macrophages in the induced sputum sample will be assessed.
Outcome measures
| Measure |
Clean Air
n=9 Participants
Subjects will be exposed to clean air for 3 hours.
Clean Air: Subjects will have the clean air exposure first, followed by the ozone exposure
|
Ozone
n=9 Participants
Subjects will be exposed to 0.2 ppm ozone for 3 hours.
Ozone: Subjects will have the ozone exposure first, followed by the clean air exposure
|
|---|---|---|
|
Concentrations of M1 and M2 Macrophages in the Sputum 48 Hours After Exposure.
|
9.783 ratio of M2 to M1 macrophages
Standard Error 3.239
|
3.449 ratio of M2 to M1 macrophages
Standard Error 1.116
|
PRIMARY outcome
Timeframe: 72 hours after exposure.Population: The number of participants who had an adequate sputum sample collected 72 hours after each exposure.
Relative concentrations of M1 and M2 macrophages in the induced sputum sample will be assessed.
Outcome measures
| Measure |
Clean Air
n=12 Participants
Subjects will be exposed to clean air for 3 hours.
Clean Air: Subjects will have the clean air exposure first, followed by the ozone exposure
|
Ozone
n=12 Participants
Subjects will be exposed to 0.2 ppm ozone for 3 hours.
Ozone: Subjects will have the ozone exposure first, followed by the clean air exposure
|
|---|---|---|
|
Concentrations of M1 and M2 Macrophages in the Sputum 72 Hours After Exposure.
|
4.623 ratio of M2 to M1 macrophages
Standard Error 0.782
|
4.379 ratio of M2 to M1 macrophages
Standard Error 0.623
|
Adverse Events
Clean Air
Ozone
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Andrew Gow, PhD
Rutgers, the State University of New Jersey
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place