Air PollutionNCT05794087
The Role of Macrophage Activation in Lung Injury Following Ozone Exposure
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.
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. The exposure visits will be at least 2 weeks apart. Subjects will be asked to produce sputum through coughing after each exposure. 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?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2023to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
None listed.
Who cannot join
- Cardiovascular disease
- Respiratory disease
- Recent (within 4 weeks) respiratory or COVID-19 symptoms
- Diabetes
- Pregnancy
- HIV Infection
Show all 10Show fewer
- History of smoking within the past 5 years.
- Orthopedic or rheumatologic conditions which would interfere with cycle use
- Inability to produce a sputum plug at screening
- Daily use of antioxidant supplements, excluding those in a multivitamin. These supplements include Vitamin C or E, selenium, beta-carotene, lycopene, lutein, zeaxanthin and ginkgo biloba. Supplements taken less frequently but at least once a week will be reviewed by the principal investigator for eligibility determination.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rutgers - EOHSI
Piscataway, New Jersey, 08854
Kathy Black, PhD, 848-445-6049, kgblack@eohsi.rutgers.edu
Adriana De Resende, 848-445-0178, ad998@eohsi.rutgers.edu
About this study
Official title: Activated Macrophages and Ozone Toxicity II
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. The exposure visits will be at least 2 weeks apart. Subjects will be asked to produce sputum through coughing after each exposure. The samples will be analyzed for macrophage activity.
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, at least 2 weeks apart. 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 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 be exposed to clean air for 3 hours.
OzoneOther
Subjects will be exposed to 0.2 ppm ozone for 3 hours.
| Study group | Role | What they receive |
|---|---|---|
| Clean Air, Then Ozone | Experimental | Subjects will be exposed to clean air for 3 hours at the first exposure visit and 0.2ppm ozone for 3 hours at the second exposure visit. The visits will be at least 2 weeks apart. Receives: Other: Clean Air; Other: Ozone |
| Ozone, Then Clean Air | Experimental | Subjects will be exposed to 0.2 ppm ozone for 3 hours at the first exposure visit and clean air for 3 hours at the second exposure visit. The visits will be at least 2 weeks apart. Receives: Other: Clean Air; Other: Ozone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic activity of inflammatory cells in induced sputum
The metabolic activity of inflammatory cells in sputum will be assessed by the measurement of ATP production. The measurement will be made on an Agilent Seahorse using a Mitoplate Assay.
Measured: Within 3 days of exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start7 Feb 2023
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Subjects will be randomly assigned to either clean air or ozone for the first exposure then crossed over to the alternate arm for the second exposure.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Principal investigator, Howard M. Kipen, MD, MPH, Rutgers, The State University of New Jersey
- Investigators
- Howard M Kipen, MD, Principal investigator, Rutgers School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794087
- Sponsor's protocol ID
- Pro2022002024
- Other IDs
- R01ES004738
- Status last verified
- Dec 2025
- First submitted
- 10 Feb 2023
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activated Macrophages and Ozone Toxicity II
- ClinicalTrials.gov ID
- NCT05794087
- Acronym / sponsor ID
- Pro2022002024
- Conditions
- Air Pollution
- Keywords
- Macrophage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. The exposure visits will be at least 2 weeks apart. Subjects will be asked to produce sputum through coughing after each exposure. The samples will be analyzed for macrophage activity.
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, at least 2 weeks apart. 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 and exhaled breath samples will also be collected at each visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomly assigned to either clean air or ozone for the first exposure then crossed over to the alternate arm for the second exposure.
| Arm | Type | Receives |
|---|---|---|
| Clean Air, Then Ozone | Experimental | Other: Clean Air, Other: OzoneSubjects will be exposed to clean air for 3 hours at the first exposure visit and 0.2ppm ozone for 3 hours at the second exposure visit. The visits will be at least 2 weeks apart. |
| Ozone, Then Clean Air | Experimental | Other: Clean Air, Other: OzoneSubjects will be exposed to 0.2 ppm ozone for 3 hours at the first exposure visit and clean air for 3 hours at the second exposure visit. The visits will be at least 2 weeks apart. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Cardiovascular disease
- Respiratory disease
- Recent (within 4 weeks) respiratory or COVID-19 symptoms
- Diabetes
- Pregnancy
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 be exposed to clean air for 3 hours. | Other | Clean Air, Then Ozone, Ozone, Then Clean Air |
| OzoneSubjects will be exposed to 0.2 ppm ozone for 3 hours. | Other | Clean Air, Then Ozone, Ozone, Then Clean Air |
Primary outcome
Metabolic activity of inflammatory cells in induced sputum
Time frame: Within 3 days of exposure
The metabolic activity of inflammatory cells in sputum will be assessed by the measurement of ATP production. The measurement will be made on an Agilent Seahorse using a Mitoplate Assay.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Howard M Kipen, MD 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 0 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 17 Dec 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathleen Black, PhD (8484456049, kgblack@eohsi.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic activity of inflammatory cells in induced sputum (time frame: Within 3 days of exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2025.