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

Phase 1

Completed

• Conditions: Healthy Adults

• Registration Number: NCT00654134
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2008-04-01
• Study First Submitted QC: 2008-04-04
• Study First Posted: 2008-04-07
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-06
• Last Update Posted: 2013-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

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Exclusion Criteria

• Reduced Lung function
• Asthma

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine the inflammatory response to 20,000 endotoxin units (EU) of CCRE (Clinical Center Reference Endotoxin) inhalation in a cohort of healthy volunteers.	6 hours post challenge

Trial Locations

Locations (1)

Us Epa Hsf; 🇺🇸 Chapel Hill, North Carolina, United States