N/A N=15 Randomized Double-blind Basic Science

Human Biological Responses to Low Level Ozone

Environmental Exposure · Nasal Inflammation

Bottom Line

View on ClinicalTrials.gov: NCT02857283 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2020

Primary outcome: Primary: Change in % Polymorphonuclear Leukocytes (PMN) in Nasal Lavage Fluid Immediately Post-Exposure From Baseline — -1.02; -6.8 percent PMNs in nasal lavage fluid

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Ozone (Other); Filtered Air (Other); Health and Exposure Tracker (HET) (Device)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of North Carolina, Chapel Hill
Primary completion: May 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in % Polymorphonuclear Leukocytes (PMN) in Nasal Lavage Fluid Immediately Post-Exposure From Baseline	-1.02; -6.8	—
PRIMARY Change in % Polymorphonuclear Leukocytes (PMN) in Nasal Lavage Fluid 24 Hours Post-Exposure From Baseline	17.18; -27.97	—
SECONDARY Interleukin-6 (IL-6) Concentrations in Nasal Epithelial Lining Fluid (ELF): Change Immediately Post-Exposure From Baseline	2.28; 5.33	0.46
SECONDARY % Polymorphonuclear Leukocytes (PMN) in Induced Sputum: Change 24 Hours Post-Exposure From Screening Visit	12.04; 21.86	0.0481 sig
SECONDARY The Percentage of Predicted Forced Expiratory Volume in One Second (% Predicted FEV1): Change Immediately Post-Exposure From Baseline	0.79; -2.00	0.0179 sig
SECONDARY Interleukin-6 (IL-6) Concentrations in Nasal Epithelial Lining Fluid (ELF): Change 24 Hours Post-Exposure From Baseline	4.15; 11.25	0.10
SECONDARY Interleukin-8 (IL-8) Concentrations in Nasal Epithelial Lining Fluid (ELF): Change Immediately Post-Exposure From Baseline	2036.75; 2939.08	0.69
SECONDARY Interleukin-8 (IL-8) Concentrations in Nasal Epithelial Lining Fluid (ELF): Change 24 Hours Post-Exposure From Baseline	3524.77; 6696.56	0.27
SECONDARY Left Ventricular Strain (LVS): Change Immediately Post-Exposure From Baseline	0.58; 0.06	0.50
SECONDARY Nasal Epithelial Cell IL-1 Beta Gene Expression: Relative mRNA Counts Immediately Post-Exposure (Baseline-corrected), Ozone vs Filtered Air	-169.6; -147.4	0.54
SECONDARY Flow Mediated Dilation (FMD): Change Immediately Post-Exposure From Baseline	1.09; 1.25	0.90
SECONDARY Change in Heart Rate Variability	—	—
SECONDARY Nasal Epithelial Cell IL-6R Gene Expression: Relative mRNA Counts Immediately Post-Exposure (Baseline-corrected), Ozone vs Filtered Air	-10.22; -4.72	0.64
SECONDARY Nasal Epithelial Cell IL-8 Gene Expression: Relative mRNA Counts Immediately Post-Exposure (Baseline-corrected), Ozone vs Filtered Air	-537.7; 399.7	0.79
SECONDARY The Percentage of Predicted Forced Vital Capacity (% Predicted FVC): Change Immediately Post-Exposure From Baseline	-0.3; -1.8	0.094

Summary

To investigate if low level ozone exposure will cause measurable inflammation in nasal cells.

Eligibility Criteria

Inclusion Criteria

Males and females between 18 and 50 years of age.
Vital signs within normal limits on admission to the study: Peripheral oxygen saturation (SpO2) > 94%, systolic blood pressure between 150-90 mm Hg, diastolic blood pressure between 100-60 mm Hg, afebrile.
Forced Expiratory Volume (FEV1) of at least 80% of predicted.

Exclusion Criteria

Any chronic medical condition considered by the PI as a contraindication to the exposure study, including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, chronic thyroid disease, or kidney disease.
Use of systemic or inhaled steroids.
Use of NSAID or aspirin within 7days of each study visit, and inability to withhold these medications prior to each session of the study.
Pregnant or nursing women
Use of cigarettes or other inhaled nicotine products within the past year, or more than a lifetime 5 pack year history of cigarette smoking.

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Data sourced from ClinicalTrials.gov (NCT02857283). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.