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NCT03861390 · ClinicalTrials.gov registry record · Phase 1
Woodsmoke Particulate + Prednisone
A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT03861390: Completed Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
NCT03861390 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03861390, a Phase 1 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
Deployment of military personnel has been associated with increased respiratory illness likely due, in part, to inhalation of unusual particulate matter (PM), such as from burn pits. Inflammation is a key initial response to inhaled particulates. The researchers have developed a protocol using inhaled wood smoke particles (WSP) as a way to study PM-induced airway inflammation. Exposure to wood smoke particles causes symptoms, even in healthy people, such as eye irritation, cough, shortness of breath, and increased mucous production. The purpose of this research study is to see if an oral steroid treatment can reduce the airway inflammation caused by the inhaled WSP. The exposure will be 500 µg/m³ of WSP for 2 hours, with intermittent exercise on a bicycle and rest. The wood is burned in a typical wood stove and piped into the chamber.
Primary Outcome
Change in sputum percent neutrophils from baseline to 4 hours post WSP exposure
Interventions
- DRUG Placebo
- DRUG 60 mg Prednisone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-03-22 |
| Est. Completion | 2023-05-12 |
| Phase | Phase 1 |
What the finished NCT03861390 record still lists
NCT03861390 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03861390 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03861390 about?
NCT03861390 is a clinical study titled "Woodsmoke Particulate + Prednisone". Deployment of military personnel has been associated with increased respiratory illness likely due, in part, to inhalation of unusual particulate matter (PM), such as from burn pits. Inflammation is a key initial response to inhaled particulates. The researchers have developed a protocol using inhal...
What is the current status of trial NCT03861390?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2019-03-22. Estimated completion is 2023-05-12.
What interventions are being tested in trial NCT03861390?
The interventions under investigation include: Placebo (DRUG), 60 mg Prednisone (DRUG).
Who is sponsoring clinical trial NCT03861390?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03861390's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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