drugset
drugset / Trial / NCT03623022

Effects of 20,000 EU of Clinical Center Reference Endotoxin (CCRE) Versus Placebo(ENDOHEART)

NCT03623022 ↗

Phase 1 Completed 15 enrolled University of North Carolina, Chapel Hill Environmental Protection Agency (EPA) · collabRTI International · collabUnited States Department of Defense · collab
RandomizedCrossoverQuadruple-blindOther

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.

Timeline

Start
2018-10-17
Primary completion
2019-09-17
Completion
2019-09-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Lipopolysaccharide Other / unclassified 20000 unknown Inhaled

Indications

No indication recorded.