Trial Outcomes & Findings for ONES Grant: CXCL10/CXCR3 Regulation of Ozone-Induced Epithelial Permeability (NCT NCT03599206)
NCT ID: NCT03599206
Last Updated: 2026-06-15
Results Overview
This measure is defined by the comparing each individuals baseline (following filtered air challenge) to the ozone response. The investigators will perform two tests on this response as a means of confirmation. The individual will have blood drawn to obtain serum and a bronchoscopy to obtain bronchoalveolar lavage. The serum will be used to determine the level of clara cell secretory protein. This is measured by enzyme-linked immunosorbent assay (ELISA). The value is reported as ng/mL.
COMPLETED
EARLY_PHASE1
14 participants
Baseline, 21 days
2026-06-15
Participant Flow
Participant milestones
| Measure |
Ozone, Then Filtered Air
Ozone: Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing Ozone (O3).
Filtered Air: Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing filtered air.
|
Filtered Air, Then Ozone
Filtered Air: Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing filtered air.
Ozone: Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing Ozone (O3).
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
|
Overall Study
COMPLETED
|
2
|
6
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ONES Grant: CXCL10/CXCR3 Regulation of Ozone-Induced Epithelial Permeability
Baseline characteristics by cohort
| Measure |
Ozone and Filtered Air
n=8 Participants
Ozone: Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing Ozone (O3).
Filtered Air: Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing filtered air.
|
|---|---|
|
Age, Continuous
|
37.91 years
STANDARD_DEVIATION 4.39 • n=20 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Baseline, 21 daysPopulation: Each participant completed both exposures.
This measure is defined by the comparing each individuals baseline (following filtered air challenge) to the ozone response. The investigators will perform two tests on this response as a means of confirmation. The individual will have blood drawn to obtain serum and a bronchoscopy to obtain bronchoalveolar lavage. The serum will be used to determine the level of clara cell secretory protein. This is measured by enzyme-linked immunosorbent assay (ELISA). The value is reported as ng/mL.
Outcome measures
| Measure |
Filtered Air
n=8 Participants
Filtered Air: Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing filtered air.
|
Ozone
n=8 Participants
Ozone: Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing Ozone (O3).
|
|---|---|---|
|
Change in Ozone (O3) Induced Epithelial Permeability, as Measured by the Level of Clara Cell Secretory Protein
|
1.275 ng/mL
Standard Deviation 0.427
|
1.142 ng/mL
Standard Deviation 0.107
|
PRIMARY outcome
Timeframe: Baseline, 21 daysPopulation: Each participant completed both exposures.
This measure is defined by the comparing each individuals baseline (following filtered air challenge) to the ozone response. The investigators will perform two tests on this response as a means of confirmation. The individual will have blood drawn to obtain serum and a bronchoscopy to obtain bronchoalveolar lavage. The bronchoalveolar lavage will be similarly used to define the albumin level. Albumin is also measured by ELISA. The value is reported at ug/mL.
Outcome measures
| Measure |
Filtered Air
n=8 Participants
Filtered Air: Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing filtered air.
|
Ozone
n=8 Participants
Ozone: Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing Ozone (O3).
|
|---|---|---|
|
Change in Ozone (O3) Induced Epithelial Permeability, as Measured by Albumin Level (ug/mL)
|
49.76 ug/mL
Standard Deviation 8.42
|
50.07 ug/mL
Standard Deviation 10.12
|
SECONDARY outcome
Timeframe: Baseline, 21 daysPopulation: Data not collected due to unavailability of assay.
Measured by real-time PCR
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 21 daysPopulation: Each participant completed both exposures.
CXCL11, or C-X-C motif chemokine 11, is a protein that acts as a chemoattractant and plays a role in regulating cell migration. Measured by multiplex ELISA.
Outcome measures
| Measure |
Filtered Air
n=8 Participants
Filtered Air: Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing filtered air.
|
Ozone
n=8 Participants
Ozone: Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing Ozone (O3).
|
|---|---|---|
|
Change in Ozone (O3) Induced Bronchoalveolar Lavage CXCL11 Levels
|
2.42 pg/mL
Standard Deviation 2.15
|
1.99 pg/mL
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: Baseline, 21 daysPopulation: Each participant completed both exposures.
CXCL10 is a cytokine that has multiple roles, such as modulating innate and adaptive immune response, regulating cell growth and angiostatic effects. Measured by multiplex ELISA.
Outcome measures
| Measure |
Filtered Air
n=8 Participants
Filtered Air: Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing filtered air.
|
Ozone
n=8 Participants
Ozone: Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing Ozone (O3).
|
|---|---|---|
|
Change in Ozone (O3) Induced Bronchoalveolar Lavage CXCL10 Levels
|
697.27 pg/mL
Standard Deviation 697.12
|
1042.98 pg/mL
Standard Deviation 1118.41
|
SECONDARY outcome
Timeframe: Baseline, 21 daysPopulation: Each participant completed both exposures.
Interferon-gamma (IFN-γ) is a cytokine that plays an important role in inducing and modulating an array of immune responses. Measured by multiplex ELISA.
Outcome measures
| Measure |
Filtered Air
n=8 Participants
Filtered Air: Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing filtered air.
|
Ozone
n=8 Participants
Ozone: Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing Ozone (O3).
|
|---|---|---|
|
Change in Ozone (O3) Induced Bronchoalveolar Lavage IFN-γ Levels
|
12.73 pg/mL
Standard Deviation 16.04
|
9.52 pg/mL
Standard Deviation 6.35
|
SECONDARY outcome
Timeframe: Baseline, 21 daysPopulation: Each participant completed both exposures.
CXCL9, or C-X-C motif chemokine ligand 9, is a small cytokine that plays a role in inflammation, tumor growth, and other processes. Measured by multiplex ELISA.
Outcome measures
| Measure |
Filtered Air
n=8 Participants
Filtered Air: Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing filtered air.
|
Ozone
n=8 Participants
Ozone: Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing Ozone (O3).
|
|---|---|---|
|
Change in Ozone (O3) Induced Bronchoalveolar Lavage CXCL9 Levels
|
230.64 pg/mL
Standard Deviation 169.88
|
227.55 pg/mL
Standard Deviation 245.33
|
Adverse Events
Ozone and Filtered Air
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place