Human Biological Responses to Low Level Ozone

NCT02857283 | Completed Results FDA Device

• 1 other identifier: 15-2677
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Environmental Exposure; Nasal Inflammation

Keywords

Air pollution; Air pollutant exposure; Ozone

Outcome Measures

Primary Outcomes (2)

• Change in % Polymorphonuclear Leukocytes (PMN) in Nasal Lavage Fluid Immediately Post-Exposure From Baseline

  Participants will be exposed to either filtered air (FA), then ozone (O3), or O3, then FA. Nasal lavage fluid (NLF) will be collected from participants at a baseline visit within two weeks prior to each exposure, and at the following time points for each exposure: immediately after exiting the exposure chamber, and at 24 hours after the exposure. The % PMN as a percentage of total inflammatory cells (total of monocytes and macrophages, PMN, eosinophils, basophils, lymphocytes, and bronchial epithelial cells) will be determined in each NLF collection by differential counts of cells on cytospin slides. The change in the values from baseline to immediately Post-Exposure will be calculated for each participant for each exposure. Values will be compared between FA and O3.

  Baseline, immediately post-exposure

• Change in % Polymorphonuclear Leukocytes (PMN) in Nasal Lavage Fluid 24 Hours Post-Exposure From Baseline

  Participants will be exposed to either filtered air (FA), then ozone (O3), or O3, then FA. Nasal lavage fluid (NLF) will be collected from participants at a baseline visit within two weeks prior to each exposure, and at the following time points for each exposure: immediately after exiting the exposure chamber, and at 24 hours after the exposure. The % PMN as a percentage of total inflammatory cells (total of monocytes and macrophages, PMN, eosinophils, basophils, lymphocytes, and bronchial epithelial cells) will be determined in each NLF collection by differential counts of cells on cytospin slides. The change in the values from baseline to 24 hours Post-Exposure will be calculated for each participant for each exposure. Values will be compared between FA and O3.

  Baseline, 24 hours post-exposure

Secondary Outcomes (13)

• Interleukin-6 (IL-6) Concentrations in Nasal Epithelial Lining Fluid (ELF): Change Immediately Post-Exposure From Baseline

  Baseline, immediately post-exposure

• % Polymorphonuclear Leukocytes (PMN) in Induced Sputum: Change 24 Hours Post-Exposure From Screening Visit

  Screening visit and 24 hours post-exposure

• The Percentage of Predicted Forced Expiratory Volume in One Second (% Predicted FEV1): Change Immediately Post-Exposure From Baseline

  Baseline, immediately post-exposure

• Interleukin-6 (IL-6) Concentrations in Nasal Epithelial Lining Fluid (ELF): Change 24 Hours Post-Exposure From Baseline

  Baseline, 24 hours post-exposure

• Interleukin-8 (IL-8) Concentrations in Nasal Epithelial Lining Fluid (ELF): Change Immediately Post-Exposure From Baseline

  Baseline, immediately post-exposure

Study Arms (2)

Filtered Air, then Ozone

EXPERIMENTAL

Participants in this arm will first receive filtered clean air followed by ozone

Other: Ozone; Other: Filtered Air; Device: Health and Exposure Tracker (HET)

Ozone, then Filtered Air

EXPERIMENTAL

Participants in this arm will first receive ozone followed by filtered clean air

Other: Ozone; Other: Filtered Air; Device: Health and Exposure Tracker (HET)

Interventions

Ozone OTHER

Participants will be exposed to a concentration of ozone for 6.5 hours at a concentration that varies 0.06 to 0.08

Filtered Air, then Ozone; Ozone, then Filtered Air

Filtered Air OTHER

Participants will be exposed to filtered clean air

Filtered Air, then Ozone; Ozone, then Filtered Air

Health and Exposure Tracker (HET) DEVICE

Ozone and heart rate tracker

Filtered Air, then Ozone; Ozone, then Filtered Air

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Environmental Protection Agency (EPA): collaborator

Study Sites (1)

Center for Environmental Medicine, Asthma and Lung Biology

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (2)

• Peden DB, Setzer RW Jr, Devlin RB. Ozone exposure has both a priming effect on allergen-induced responses and an intrinsic inflammatory action in the nasal airways of perennially allergic asthmatics. Am J Respir Crit Care Med. 1995 May;151(5):1336-45. doi: 10.1164/ajrccm.151.5.7735583.

  PMID: 7735583 BACKGROUND

• Little, R. J. and Rubin, D. B. (2014). Statistical analysis with missing data. John Wiley & Sons.

  BACKGROUND

MeSH Terms

Interventions

Ozone

Intervention Hierarchy (Ancestors)

Oxygen; Gases; Inorganic Chemicals

Results Point of Contact

• Title: Michelle Hernandez, MD
• Organization: UNC Center for Environmental Medicine, Asthma and Lung Biology

michelle_hernandez@med.unc.edu

919-843-5383

Study Officials

• David B Peden, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: August 5, 2016
• Study Start: April 22, 2017
• Primary Completion: May 1, 2019
• Study Completion: July 1, 2019
• Last Updated: May 14, 2021
• Results First Posted: April 14, 2020

Record last verified: 2021-05

Locations

US (1)