Air Pollution Study: The Effect of Ozone on the Lung

NCT02673775 | Completed Results

• 2 other identifiers: Pro20140001089R01ES004738
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to better understand the mechanisms of lung injury from ozone exposure. Subjects will participate in two exposure sessions: filtered air and 0.2 ppm ozone. Subjects will be asked to produce sputum through coughing after each exposure. The samples will be analyzed for macrophage activity.

Conditions

Air Pollution

Keywords

Macrophage

Outcome Measures

Primary Outcomes (3)

• Concentrations of M1 and M2 Macrophages in the Sputum 24 Hours After Exposure.

  The relative concentrations of M1 and M2 macrophages in the induced sputum sample will be assessed.

  24 hours after exposure.

• Concentrations of M1 and M2 Macrophages in the Sputum 48 Hours After Exposure.

  The relative concentrations of M1 and M2 macrophages in the induced sputum sample will be assessed.

  48 hours after exposure

• Concentrations of M1 and M2 Macrophages in the Sputum 72 Hours After Exposure.

  Relative concentrations of M1 and M2 macrophages in the induced sputum sample will be assessed.

  72 hours after exposure.

Study Arms (2)

Clean Air

PLACEBO COMPARATOR

Subjects will be exposed to clean air for 3 hours.

Other: Clean Air

Ozone

EXPERIMENTAL

Subjects will be exposed to 0.2 ppm ozone for 3 hours.

Other: Ozone

Interventions

Clean Air OTHER

Subjects will have the clean air exposure first, followed by the ozone exposure

Clean Air

Ozone OTHER

Subjects will have the ozone exposure first, followed by the clean air exposure

Ozone

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men and women

You may not qualify if:

• Cardiovascular disease
• Respiratory disease
• Diabetes
• Pregnancy
• HIV infection
• History of smoking within the last 5 years
• Daily use of antioxidant supplements (e.g., Vitamin C/E, selenium, beta-carotene, lycopene, lutein, zeaxanthin, or ginkgo biloba)
• Orthopedic or rheumatological conditions that would interfere with cycle use

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Study Sites (1)

Environmental and Occupational Health Sciences Institute

Piscataway, New Jersey, 08854, United States

Location

MeSH Terms

Interventions

Environment, Controlled; Ozone

Intervention Hierarchy (Ancestors)

Environment; Environment and Public Health; Oxygen; Gases; Inorganic Chemicals

Results Point of Contact

• Title: Andrew Gow, PhD
• Organization: Rutgers, the State University of New Jersey

gow@pharmacy.rutgers.edu

848-445-4612

Study Officials

• Howard M. Kipen, MD, MPH

  Rutgers School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: February 4, 2016
• Study Start: February 1, 2016
• Primary Completion: June 7, 2022
• Study Completion: June 7, 2022
• Last Updated: September 25, 2025
• Results First Posted: October 11, 2023

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)