Inhalation of 20,000 Endotoxin Units(EU) of Clinical Center Reference Endotoxin in Healthy Volunteers (Entox)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michelle Hernandez, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00654134
First received: April 1, 2008
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to determine the inflammatory response to 20,000 endotoxin units (EU) of CCRE (Clinical Center Reference Endotoxin) inhalation in a cohort of healthy volunteers. Preferably these subjects will have participated in ozone exposure studies, allowing a direct comparison of their responses to both endotoxin and ozone. Additionally, cardiovascular endpoints will be investigated with the CCRE exposure.


Condition Intervention Phase
Healthy Adults
Biological: Clinical Center Reference Endotoxin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Inhalation of 20,000 EU of Clinical Center Reference Endotoxin in Healthy Volunteers

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • To determine the inflammatory response to 20,000 endotoxin units (EU) of CCRE (Clinical Center Reference Endotoxin) inhalation in a cohort of healthy volunteers. [ Time Frame: 6 hours post challenge ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: October 2005
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Clinical Center Reference Endotoxin
    20,000 EU inhaled
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Prior participation in Ozone Study
  • Healthy adults
  • Nonsmokers
  • No chronic illness
  • No active allergies

Exclusion Criteria:

  • Reduced Lung function
  • Asthma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654134

Locations
United States, North Carolina
Us Epa Hsf
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Michelle Hernandez, MD University of North Carolina
  More Information

No publications provided

Responsible Party: Michelle Hernandez, MD, Assistant Professor of Pediatrics, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00654134     History of Changes
Other Study ID Numbers: 05-2844 GCRC 2311, US EPA, NIEHS
Study First Received: April 1, 2008
Last Updated: August 6, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014