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

Healthy Adults Clinical Trial

— Entox  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00654134
• Other study ID #: 05-2844 GCRC 2311
• Secondary ID: US EPANIEHS
• Status: Completed
• Phase: Phase 1
• First received: April 1, 2008
• Last updated: August 6, 2013
• Start date: October 2005
• Est. completion date: July 2013

Study information

• Verified date: August 2013
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Prior participation in Ozone Study

• Healthy adults

• Nonsmokers

• No chronic illness

• No active allergies

Exclusion Criteria:

• Reduced Lung function

• Asthma

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Adults

Intervention

Biological:
• Clinical Center Reference Endotoxin
20,000 EU inhaled

Locations

Country	Name	City	State
United States	Us Epa Hsf	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Environmental Health Sciences (NIEHS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes