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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: Completed Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
NCT03623022 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Comparing pre and post results before and after endotoxin vs normal saline inhalations
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 |
What the finished NCT03623022 record still lists
NCT03623022 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which Normal saline is the first listed.
NCT03623022 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03623022's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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