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Environmental Exposure

Ozone Exposure Effects on Lung Function in Healthy Subjects (MOZEPH Trial)

Phase 1
Waitlist Available
Research Sponsored by Robert Tighe, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 21 days
Awards & highlights

MOZEPH Trial Summary

This trial is testing whether environmental and genetic factors play a role in lung function. Healthy participants will undergo a series of tests, including a blood draw and breathing tests, over the course of one to one-and-a-half months.

Who is the study for?
This trial is for healthy individuals aged 18-35, regardless of gender or ethnicity. Participants should not have used antibiotics or had respiratory infections in the last month, and must not be current smokers or have quit within the past five years. Pregnant women, lactating mothers, and those with certain medical conditions are excluded.Check my eligibility
What is being tested?
The study aims to understand how breathing in ozone (O3) compared to filtered air affects lung function due to environmental and genetic factors. It involves a series of tests including blood draws, breathing tests before and after inhaling O3 or filtered air, bronchoscopy under sedation, and follow-up calls.See study design
What are the potential side effects?
Potential side effects may include discomfort from blood draws and breathing tests; risks associated with bronchoscopy such as sore throat, coughing up blood spots; reactions to sedatives like drowsiness; irritation from ozone exposure affecting lungs.

MOZEPH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 21 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 21 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in ozone induced phagocytosis of lung macrophages (ability to clear debris or bacteria)
change in ozone induced efferocytosis of lung macrophages (ability to clear dead or dying cells)
Secondary outcome measures
Body Weight Changes
Change in ozone induced increase in soluble CD163 in bronchoalveolar lavage fluid and serum

MOZEPH Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ozone (O3)Experimental Treatment1 Intervention
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).
Group II: Filtered Air (FA)Placebo Group1 Intervention
Control will be treadmill walk with filtered room air in chamber.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ozone
Not yet FDA approved

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Robert Tighe, MDLead Sponsor
2 Previous Clinical Trials
114 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,705 Previous Clinical Trials
7,507,264 Total Patients Enrolled
Ohio State UniversityOTHER
834 Previous Clinical Trials
507,939 Total Patients Enrolled

Media Library

Ozone (Environmental Exposure) Clinical Trial Eligibility Overview. Trial Name: NCT03646877 — Phase 1
Healthy Subjects Research Study Groups: Ozone (O3), Filtered Air (FA)
Healthy Subjects Clinical Trial 2023: Ozone Highlights & Side Effects. Trial Name: NCT03646877 — Phase 1
Ozone (Environmental Exposure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03646877 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to become a participant in this clinical trial?

"This medical experiment is seeking 70 participants aged between 18 and 35 that have healthy bodies. There are no exclusions based on gender or ethnicity but all volunteers must meet the outlined age criteria."

Answered by AI

Does this test currently accommodate individuals aged 40 and over?

"Results from this medical trial can only be obtained if participants meet the age requirements, which are 18 at a minimum and 35 as an upper limit."

Answered by AI

What is the aggregate number of participants engaged in this trial?

"Affirmative. The clinicaltrials.gov repository shows that, after being posted on March 19th 2019, this clinical trial is now actively recruiting from one centre for a total of 70 patients."

Answered by AI

Is this experiment still open to new volunteers?

"According to the data available on clinicaltrials.gov, this medical trial is currently enrolling suitable volunteers. The study was first published in March 2019 and recently updated in July 2022."

Answered by AI

Are there health risks associated with exposure to Ozone?

"Ozone has been deemed a 1 in terms of safety due to the preliminary nature of its clinical trials, which have provided scant evidence supporting both efficacy and security."

Answered by AI

Have other scientific experiments been conducted utilizing Ozone?

"Currently, there are 4 active trials researching the application of Ozone with one being in its third stage. Most studies take place at Las Palmas De Gran Canaria, Las Palmas however 6 other sites have opened up to run their own experiments as well."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
How old are they?
18 - 65
What site did they apply to?
Duke University Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

To make a difference in medical research as well as earn extra money for a financial rut.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Mechanisms of Ozone-Induced Alterations in Efferocytosis and Phagocytosis
Robert Tighe, MD 2019. "Mechanisms of Ozone-Induced Alterations in Efferocytosis and Phagocytosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03646877.
~4 spots leftby May 2025
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