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NCT03646877 · ClinicalTrials.gov registry record · Phase 1
Mechanisms of Ozone-Induced Alterations in Efferocytosis and Phagocytosis
A Phase 1 study, sponsored by Robert Tighe, MD.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT03646877: Completed Phase 1 study, sponsored by Robert Tighe, MD.
NCT03646877 is a Phase 1 study that has completed, run by Robert Tighe, MD. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03646877, a Phase 1 study, has completed, sponsored by Robert Tighe, MD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study 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 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.
Primary Outcome
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.
Interventions
- DRUG Ozone
- OTHER Filtered Air
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2019-03-19 |
| Est. Completion | 2023-07-27 |
| Phase | Phase 1 |
What the finished NCT03646877 record still lists
NCT03646877 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 2 interventions - of which Ozone is the first listed.
NCT03646877 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03646877 about?
NCT03646877 is a clinical study titled "Mechanisms of Ozone-Induced Alterations in Efferocytosis and Phagocytosis". 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...
What is the current status of trial NCT03646877?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2019-03-19. Estimated completion is 2023-07-27.
What interventions are being tested in trial NCT03646877?
The interventions under investigation include: Ozone (DRUG), Filtered Air (OTHER).
Who is sponsoring clinical trial NCT03646877?
This trial is sponsored by Robert Tighe, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03646877's enrollment target sits among peer trials
35 1258th of 2000 higher than 728 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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