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

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

This study is enrolling participants by invitation only.

Sponsors and Collaborators:	University of North Carolina National Institute of Environmental Health Sciences (NIEHS)
Information provided by:	The University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00654134

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
Previous Participation in Ozone Study Healthy Adults	Biological: Clinical Center Reference Endotoxin	Phase I

MedlinePlus related topics: Ozone

U.S. FDA Resources

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

Further study details as provided by The 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 ]

Estimated Enrollment:	20
Study Start Date:	October 2005
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

National Institute of Environmental Health Sciences (NIEHS)

Investigators

Principal Investigator:

Bradford D Harris, MD

University of North Carolina

More Information

Responsible Party:	UNC_Chapel Hill ( Bradford Harris, MD )
Study ID Numbers:	05-2844 GCRC 2311, US EPA, NIEHS
Study First Received:	April 1, 2008
Last Updated:	April 4, 2008
ClinicalTrials.gov Identifier:	NCT00654134
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009