HealthyPhase 1MOZEPHNCT03646877
Mechanisms of Ozone-Induced Alterations in Efferocytosis and Phagocytosis
A Phase 1 study testing Ozone and Filtered Air in people with Healthy, run by Robert Tighe, MD at 1 site in United States.
Trial summary
The purpose of this research study to understand how environmental and genetic factors may be involved in lung function. Healthy Study participants will undergo a 1-day screening that includes a blood draw and breathing testing, return for a two-day series of testing to include blood draw, and brief breathing test… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ozone and Filtered Air
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2019to 27 Jul 2023
- Phase
- Phase 1
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals between 18-35 yrs. of age (No subject will be excluded from the study on the basis of gender or ethnicity)
Who cannot join
- Current smokers of tobacco products including e-cigarettes or those with previous smoking history within the prior 5 years
- Pregnant women and women who are presently lactating.
- Subjects that have received antibiotic administration or an upper respiratory infection within the previous 4 weeks
- College and graduate students or employees who are under direct supervision by any of the investigators in this protocol
- Alcohol or illicit substance abuse
- Chronic cardio/pulmonary respiratory disorders or other medical conditions as determined by the investigator
- Increased airway hyperresponsiveness at baseline as measured by a positive methacholine challenge response (methacholine PC20 FEV1 < 8 mg/ml)
- Subjects will be requested to refrain from antihistamines, nonsteroidal anti-inflammatory agents, antioxidants (e.g. beta-carotene, selenium, and lutein) and supplemental vitamins (e.g. C and E), for 1 week prior to, and during testing.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
The purpose of this research study to understand how environmental and genetic factors may be involved in lung function. Healthy Study participants will undergo a 1-day screening that includes a blood draw and breathing testing, return for a two-day series of testing to include blood draw, and brief breathing test before and after an inhaled challenge with either filtered air (FA) or ozone (O3). Participants return the next day for a brief breathing test, a blood draw and a procedure called bronchoscopy performed under conscious sedation to evaluate the lung after the challenge.
Participants then return 18 - 20 days later to repeat the two-day series of testing to be challenged with the exposure not received on the first series, (FA or O3). Each visit will take about 3 - 3.5 hours. Follow-up phone calls from the study team will occur at 24 hours after each 2-day test series. Total study duration is about one to one-and a half months.
Read the detailed description
In brief, at V1 subjects will be assessed for baseline spirometry and venous blood analysis prior to exposure. The venous blood will be used to obtain PMNs for apoptosis assays, and serum for CFH and sCD163 levels. Additionally, this will be used to measure cytokines and growth factors. At each visit, if the subject is female, there will be a urine pregnancy test performed. Following this initial assessment, subjects will be challenged with FA or O3 and then spirometry will be performed, and venous blood will be obtained immediately following the exposure (V2). The subjects will then return 20 hours ±4h later for follow up studies (V3). There will be spirometry, a venous blood draw and urine pregnancy testing (if female) followed by bronchoscopy. At bronchoscopy, vital signs will be determined, including O2 sat. Patient then undergo an 18-20 day washout period before they are brought back in for V4 for the alternate challenge. This will follow the same protocol as outline above in the initial exposure and use the same series of analysis as the first set of visits. Therefore, we will fully characterize the biological response to ozone and filtered air in these same subjects.
- Conditions
- Healthy
- Being tested
- Ozone, Filtered Air
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzoneDrug
Also called O3
Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing Ozone (O3).
Filtered AirOther
Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing filtered air.
| Study group | Role | What they receive |
|---|---|---|
| Ozone (O3) | Experimental | The O3 level during the exposures will be 200 ppb, which has previously been used in human exposure studies without short or long term, untoward side effects (and comparable to peak levels attained during the summer in the Raleigh-Durham area of North Carolina) (REF - Bromberg review). Receives: Drug: Ozone |
| Filtered Air (FA) | Placebo comparator | Control will be treadmill walk with filtered room air in chamber. Receives: Other: Filtered Air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ozone Induced Efferocytosis of Lung Macrophages (Ability to Clear Dead or Dying Cells)
Efferocytosis is defined by determining the number of apoptotic PMNs phagocytized by alveolar macrophages (BAL cytospins) versus the total number of macrophages ('efferocytic index'). The efferocytic index is a measure of how efficiently macrophages engulf and clear apoptotic (dying) cells. It can be determined by counting the number of macrophages that have a phagocytosed apoptotic body and dividing it by the total number of macrophages counted. A higher value is considered better.
Measured: Baseline, 21 days
Change in Ozone Induced Phagocytosis of Lung Macrophages (Ability to Clear Debris or Bacteria)
Bronchoalveolar macrophages are incubated with pHrodo™ dye-labeled particles. Macrophage phagocytosis will be defined by determining the number of macrophages that contain fluorescent particles versus the total macrophages. Cell free hemoglobin and soluble CD163 - both are measured by commercial ELISA kit.
Measured: Baseline, 21 days
Secondary outcomes (2)
Change in Ozone Induced Increase in Cell Free Hemoglobin in Bronchoalveolar Lavage Fluid
Measured by spectroscopy.
Measured: Baseline, 21 days
Change in Ozone Induced Increase in Soluble CD163 in Bronchoalveolar Lavage Fluid
Measured by enzyme-linked immunosorbent assay (ELISA)
Measured: Baseline, 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start19 Mar 2019
- Primary completion26 Jul 2023
- Study completion27 Jul 2023
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 HealthyStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Tighe, MD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Ohio State University
- Responsible party
- Sponsor-investigator, Robert Tighe, MD, Duke University
- Investigators
- Robert Tighe, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646877
- Sponsor's protocol ID
- PRO00100375
- Other IDs
- ES028829
- Acronym
- MOZEPH
- Status last verified
- Jun 2026
- First submitted
- 23 Aug 2018
- Last updated
- 15 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Ozone-Induced Alterations in Efferocytosis and Phagocytosis
- ClinicalTrials.gov ID
- NCT03646877
- Acronym / sponsor ID
- MOZEPH / PRO00100375
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Robert Tighe, MDUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Ohio State University
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- 26 Jul 2023 (actual)
- Study completion
- 27 Jul 2023 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Posted 15 Jun 2026
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 this research study to understand how environmental and genetic factors may be involved in lung function. Healthy Study participants will undergo a 1-day screening that includes a blood draw and breathing testing, return for a two-day series of testing to include blood draw, and brief breathing test before and after an inhaled challenge with either filtered air (FA) or ozone (O3). Participants return the next day for a brief breathing test, a blood draw and a procedure called bronchoscopy performed under conscious sedation to evaluate the lung after the challenge.
Participants then return 18 - 20 days later to repeat the two-day series of testing to be challenged with the exposure not received on the first series, (FA or O3). Each visit will take about 3 - 3.5 hours. Follow-up phone calls from the study team will occur at 24 hours after each 2-day test series. Total study duration is about one to one-and a half months.
Detailed description
In brief, at V1 subjects will be assessed for baseline spirometry and venous blood analysis prior to exposure. The venous blood will be used to obtain PMNs for apoptosis assays, and serum for CFH and sCD163 levels. Additionally, this will be used to measure cytokines and growth factors. At each visit, if the subject is female, there will be a urine pregnancy test performed. Following this initial assessment, subjects will be challenged with FA or O3 and then spirometry will be performed, and venous blood will be obtained immediately following the exposure (V2). The subjects will then return 20 hours ±4h later for follow up studies (V3). There will be spirometry, a venous blood draw and urine pregnancy testing (if female) followed by bronchoscopy. At bronchoscopy, vital signs will be determined, including O2 sat. Patient then undergo an 18-20 day washout period before they are brought back in for V4 for the alternate challenge. This will follow the same protocol as outline above in the initial exposure and use the same series of analysis as the first set of visits. Therefore, we will fully characterize the biological response to ozone and filtered air in these same subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ozone (O3) | Experimental | Drug: OzoneThe O3 level during the exposures will be 200 ppb, which has previously been used in human exposure studies without short or long term, untoward side effects (and comparable to peak levels attained during the summer in the Raleigh-Durham area of North Carolina) (REF - Bromberg review). |
| Filtered Air (FA) | Placebo comparator | Other: Filtered AirControl will be treadmill walk with filtered room air in chamber. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Individuals between 18-35 yrs. of age (No subject will be excluded from the study on the basis of gender or ethnicity)
Key exclusion criteria (8 listed)
- Current smokers of tobacco products including e-cigarettes or those with previous smoking history within the prior 5 years
- Pregnant women and women who are presently lactating.
- Subjects that have received antibiotic administration or an upper respiratory infection within the previous 4 weeks
- College and graduate students or employees who are under direct supervision by any of the investigators in this protocol
- Alcohol or illicit substance abuse
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 |
|---|---|---|
| OzoneAlso: O3Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing Ozone (O3). | Drug | Ozone (O3) |
| Filtered AirSubjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing filtered air. | Other | Filtered Air (FA) |
Primary outcome
Change in Ozone Induced Efferocytosis of Lung Macrophages (Ability to Clear Dead or Dying Cells)
Time frame: Baseline, 21 days
Efferocytosis is defined by determining the number of apoptotic PMNs phagocytized by alveolar macrophages (BAL cytospins) versus the total number of macrophages ('efferocytic index'). The efferocytic index is a measure of how efficiently macrophages engulf and clear apoptotic (dying) cells. It can be determined by counting the number of macrophages that have a phagocytosed apoptotic body and dividing it by the total number of macrophages counted. A higher value is considered better.
Change in Ozone Induced Phagocytosis of Lung Macrophages (Ability to Clear Debris or Bacteria)
Time frame: Baseline, 21 days
Bronchoalveolar macrophages are incubated with pHrodo™ dye-labeled particles. Macrophage phagocytosis will be defined by determining the number of macrophages that contain fluorescent particles versus the total macrophages. Cell free hemoglobin and soluble CD163 - both are measured by commercial ELISA kit.
2 secondary outcomes
Change in Ozone Induced Increase in Cell Free Hemoglobin in Bronchoalveolar Lavage Fluid
Time frame: Baseline, 21 days
Change in Ozone Induced Increase in Soluble CD163 in Bronchoalveolar Lavage Fluid
Time frame: Baseline, 21 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Robert Tighe, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ozone and Filtered Air in people with Healthy, run by Robert Tighe, MD 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 15 Jun 2026. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2026). 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?
Change in Ozone Induced Efferocytosis of Lung Macrophages (Ability to Clear Dead or Dying Cells) (time frame: Baseline, 21 days). The study lists 2 primary outcomes in all. 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 15 Jun 2026.