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

Primary Purpose

Healthy Adults

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Clinical Center Reference Endotoxin

About this trial

This is an interventional basic science trial for Healthy Adults

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Reduced Lung function
Asthma

Sites / Locations

Us Epa Hsf

Outcomes

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00654134

First Posted

April 1, 2008

Last Updated

August 6, 2013

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute of Environmental Health Sciences (NIEHS)

1. Study Identification

Unique Protocol Identification Number

NCT00654134

Brief Title

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

Acronym

Entox

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

October 2005 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute of Environmental Health Sciences (NIEHS)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy Adults

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

Clinical Center Reference Endotoxin

Intervention Description

20,000 EU inhaled

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Prior participation in Ozone Study Healthy adults Nonsmokers No chronic illness No active allergies Exclusion Criteria: Reduced Lung function Asthma

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michelle Hernandez, MD

Organizational Affiliation

University of North Carolina

Official's Role

Principal Investigator

Facility Information:

Facility Name

Us Epa Hsf

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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