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NCT03623022 · ClinicalTrials.gov registry record · Phase 1
Effects of 20,000 EU of Clinical Center Reference Endotoxin (CCRE) Versus Placebo(ENDOHEART)
A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT03623022 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 15 participants.
The verdict
NCT03623022, a Phase 1 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
To determine the systemic inflammatory effects of inhaled endotoxin and associated alterations in cardiovascular function. Subjects will undergo an exposure to inhaled endotoxin in a crossover fashion with normal saline inhalation. Blood samples and sputum samples will be taken before and after inhalation challenge to measure markers of systemic inflammation. Cardiovascular measures, including a heart rate variability monitor, flow mediated dilation of the brachial artery and left ventricular stain will also be measured.
Interventions
- DRUG Normal saline
- DRUG Clinical Center Reference Endotoxin (CCRE)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2018-10-17 |
| Est. Completion | 2019-09-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03623022
The ClinicalTrials.gov registry entry for NCT03623022 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 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 Normal saline is the first listed.
NCT03623022 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03623022 about?
NCT03623022 is a clinical study titled "Effects of 20,000 EU of Clinical Center Reference Endotoxin (CCRE) Versus Placebo(ENDOHEART)". To determine the systemic inflammatory effects of inhaled endotoxin and associated alterations in cardiovascular function. Subjects will undergo an exposure to inhaled endotoxin in a crossover fashion with normal saline inhalation. Blood samples and sputum samples will be taken before and after inha...
What is the current status of trial NCT03623022?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2018-10-17. Estimated completion is 2019-09-17.
What interventions are being tested in trial NCT03623022?
The interventions under investigation include: Normal saline (DRUG), Clinical Center Reference Endotoxin (CCRE) (DRUG).
Who is sponsoring clinical trial NCT03623022?
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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