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Sponsors and Collaborators: |
University of North Carolina National Institute of Environmental Health Sciences (NIEHS) |
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Information provided by: | The University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT00654134 |
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 |
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Previous Participation in Ozone Study Healthy Adults |
Biological: Clinical Center Reference Endotoxin |
Phase I |
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 |
Estimated Enrollment: | 20 |
Study Start Date: | October 2005 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
US EPA HSF | |
Chapel Hill, North Carolina, United States, 27599 |
Principal Investigator: | Bradford D Harris, MD | University of North Carolina |
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 |
Healthy |