Air PollutionNCT02673775

Air Pollution Study: The Effect of Ozone on the Lung

A study testing Clean Air and Ozone in people with Air Pollution, run by Rutgers, The State University of New Jersey at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Air Pollution
What is being tested?: Clean Air and Ozone
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 135 participants
Where: 1 siteUnited States
Study dates: Feb 2016to 7 Jun 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy men and women

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Environmental and Occupational Health Sciences Institute
Piscataway, New Jersey, 08854

Other trials in United States

About this study

Official title: Activated Macrophages and Ozone Toxicity

Read the detailed description

Subjects will be asked to come to the Rutgers EOHSI clinical center (Piscataway, NJ) for 5 study visits. A physical exam to determine eligibility will be done at the first study visit. If the subject is healthy and able to produce a sputum sample, he/she will then be scheduled for 2 3-hour exposure visits. One exposure will be to clean air and the other exposure will be to 0.2 ppm ozone. During the exposures, subjects will be requested to ride an exercise bicycle intermittently (approximately every 15 minutes). A follow-up visit for sputum collection will be scheduled either 24, 48, or 72 hours after each exposure visit. Blood, urine, and exhaled breath samples will also be collected at each visit.

Conditions: Air Pollution
Being tested: Clean Air, Ozone
Keywords: Macrophage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02673775
Study group	Role	What they receive
Clean Air	Placebo comparator	Subjects will be exposed to clean air for 3 hours. Receives: Other: Clean Air
Ozone	Experimental	Subjects will be exposed to 0.2 ppm ozone for 3 hours. Receives: Other: Ozone

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 72 hours after exposure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 20167 Jun 2022

First posted4 Feb 2016 (estimated)
Study startFeb 2016
Primary completion7 Jun 2022
Study completion7 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Air PollutionStudies of the same condition, open and under way.
More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 135 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02673775
Sponsor's protocol ID: Pro20140001089
Other IDs: R01ES004738
Status last verified: Sep 2025
First submitted: 29 Jan 2016
Last updated: 25 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: The individual data will be confidential.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Activated Macrophages and Ozone Toxicity
ClinicalTrials.gov ID: NCT02673775
Acronym / sponsor ID: Pro20140001089
Conditions: Air Pollution
Keywords: Macrophage
Study type: Interventional
Recruitment status: Completed
Enrolment: 135 participants (actual)
Lead sponsor: Rutgers, The State University of New JerseyUniversity, hospital or other
Collaborators: National Institute of Environmental Health Sciences (NIEHS)
Study start: Feb 2016 (actual)
Primary completion: 7 Jun 2022 (actual)
Study completion: 7 Jun 2022 (actual)
First posted: 4 Feb 2016 (estimated)
Results: Posted 11 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Clean Air	Placebo comparator	Other: Clean AirSubjects will be exposed to clean air for 3 hours.
Ozone	Experimental	Other: OzoneSubjects will be exposed to 0.2 ppm ozone for 3 hours.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Healthy men and women

Key exclusion criteria (8 listed)

Cardiovascular disease
Respiratory disease
Diabetes
Pregnancy
HIV infection

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Clean AirSubjects will have the clean air exposure first, followed by the ozone exposure	Other	Clean Air
OzoneSubjects will have the ozone exposure first, followed by the clean air exposure	Other	Ozone

Primary outcome

Concentrations of M1 and M2 Macrophages in the Sputum 24 Hours After Exposure.
Time frame: 24 hours after exposure.
The relative concentrations of M1 and M2 macrophages in the induced sputum sample will be assessed.
Concentrations of M1 and M2 Macrophages in the Sputum 48 Hours After Exposure.
Time frame: 48 hours after exposure
The relative concentrations of M1 and M2 macrophages in the induced sputum sample will be assessed.
Concentrations of M1 and M2 Macrophages in the Sputum 72 Hours After Exposure.
Time frame: 72 hours after exposure.
Relative concentrations of M1 and M2 macrophages in the induced sputum sample will be assessed.

Results and safety

Results posted to the registry on 11 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ozone Exposure Was First, Followed by Clean Air Exposure	25	25
Clean Air Exposure Was First, Followed by Ozone Exposure	37	37

Primary outcome: Concentrations of M1 and M2 Macrophages in the Sputum 24 Hours After Exposure.

Time frame: 24 hours after exposure.. Mean (Standard Error). Unit: ratio of M2 to M1 macrophages

Measure	Clean Air n = 13	Ozone n = 13
Value	6.823 (2.413)	1.367 (0.367)

Population analysed: The number of participants who had an adequate sputum sample collected 24 hours after each exposure.

Primary outcome: Concentrations of M1 and M2 Macrophages in the Sputum 48 Hours After Exposure.

Time frame: 48 hours after exposure. Mean (Standard Error). Unit: ratio of M2 to M1 macrophages

Measure	Clean Air n = 9	Ozone n = 9
Value	9.783 (3.239)	3.449 (1.116)

Population analysed: The number of participants who had an adequate sputum sample collected 48 hours after each exposure.

Primary outcome: Concentrations of M1 and M2 Macrophages in the Sputum 72 Hours After Exposure.

Time frame: 72 hours after exposure.. Mean (Standard Error). Unit: ratio of M2 to M1 macrophages

Measure	Clean Air n = 12	Ozone n = 12
Value	4.623 (0.782)	4.379 (0.623)

Population analysed: The number of participants who had an adequate sputum sample collected 72 hours after each exposure.

Adverse events

Time frame: Adverse event data were collected until the sputum sample was collected; up to 3 days after the exposure. Induced sputum was collected either 24, 48, or 72 hours after exposure; at the time of sputum collection participants were queried about any effects of the exposure including the need to see medical treatment for breathing difficulties.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Clean Air	0 of 58 (0%)	0 of 58 (0%)	0 of 58
Ozone	0 of 58 (0%)	0 of 58 (0%)	0 of 58

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. The individual data will be confidential.

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Recruiting
Ambient Air and Noise Effect on Cardiovascular Health Risk and Lifestyle Intervention to Attenuate It (METSGREEN)
Cardiovascular Diseases (CVD), Metabolic Syndrome
Recruiting
Lungs on Fire: Wildfire Smoke, Incident Diseases, Susceptible Populations, and Community Values in Canada
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Recruiting
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Active, not recruiting
AIRWEIGHS: Investigating Obesity as a Susceptibility Factor for Air Pollution in Childhood Asthma
Asthma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Howard M. Kipen, MD, MPH principal investigator

Rutgers School of Public Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Clean Air and Ozone in people with Air Pollution, run by Rutgers, The State University of New Jersey at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concentrations of M1 and M2 Macrophages in the Sputum 24 Hours After Exposure. (time frame: 24 hours after exposure.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02673775.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.