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

August 6, 2013 updated by: Michelle Hernandez, MD, University of North Carolina, Chapel Hill

Inhalation of 20,000 EU of Clinical Center Reference Endotoxin in Healthy Volunteers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Us Epa Hsf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Reduced Lung function
  • Asthma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 hours post challenge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute of Environmental Health Sciences (NIEHS)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

April 1, 2008

First Submitted That Met QC Criteria

April 4, 2008

First Posted (Estimate)

April 7, 2008

Study Record Updates

Last Update Posted (Estimate)

August 9, 2013

Last Update Submitted That Met QC Criteria

August 6, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-2844 GCRC 2311
  • US EPA
  • NIEHS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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