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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 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 12 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03861390
The ClinicalTrials.gov registry entry for NCT03861390 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03861390 reports 0 study locations.
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.
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