Inhalation of 20,000 Endotoxin Units(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.

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Key information

Conditions

Healthy Adults

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Us Epa Hsf

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Reduced Lung function
Asthma

Treatment and study plan

Clinical Center Reference Endotoxin

Biological

20,000 EU inhaled

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

National Institute of Environmental Health Sciences (NIEHS)

Registry information

Official study title

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

Acronym: Entox

Important dates

Study start: 2005
Primary completion: 2013
Study completion: 2013
First posted: Apr 7, 2008
Registry last updated: Aug 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed