- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03646877
Mechanisms of Ozone-Induced Alterations in Efferocytosis and Phagocytosis (MOZEPH)
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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Claudia Salazar
- Phone Number: 919-660-2026
- Email: claudia.salazar@duke.edu
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria
• Individuals between 18-35 yrs. of age (No subject will be excluded from the study on the basis of gender or ethnicity)
Exclusion Criteria
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ozone (O3)
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).
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Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing Ozone (O3).
Other Names:
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Placebo Comparator: Filtered Air (FA)
Control will be treadmill walk with filtered room air in chamber.
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Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing filtered air.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in ozone induced efferocytosis of lung macrophages (ability to clear dead or dying cells)
Time Frame: Baseline, 21 days
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Efferocytosis is defined by determining the number of apoptotic PMNs phagocytized by alveolar macrophages (BAL cytospins) versus the total number of macrophages ('efferocytic index')
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Baseline, 21 days
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Change in ozone induced phagocytosis of lung macrophages (ability to clear debris or bacteria)
Time Frame: Baseline, 21 days
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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
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Baseline, 21 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in ozone induced increase in cell free hemoglobin in bronchoalveolar lavage fluid and serum
Time Frame: Baseline, 21 days
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Measured by enzyme-linked immunosorbent assay (ELISA)
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Baseline, 21 days
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Change in ozone induced increase in soluble CD163 in bronchoalveolar lavage fluid and serum
Time Frame: Baseline, 21 days
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Measured by enzyme-linked immunosorbent assay (ELISA)
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Baseline, 21 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert Tighe, MD, Duke University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PRO00100375
- ES028829 (Other Grant/Funding Number: NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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