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

NCT03623022 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2019-09-20

No results posted yet for this 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.

Conditions

  • Healthy

Interventions

DRUG

Clinical Center Reference Endotoxin (CCRE)

subjects will undergo an exposure to inhaled endotoxin through a nebulizer for approximately 10 minutes.

DRUG

Normal saline

subjects will undergo an exposure to inhaled normal saline through a nebulizer for approximately 10 minutes

Sponsors & Collaborators

  • Environmental Protection Agency (EPA)

    collaborator FED

  • RTI International

    collaborator OTHER

  • United States Department of Defense

    collaborator FED

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Michelle Hernandez, MD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-17
Primary Completion
2019-09-17
Completion
2019-09-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03623022 on ClinicalTrials.gov