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

University of North Carolina (UNC)

Status and phase: Completed; Phase 1

Conditions: Healthy Adults

Treatments: Biological: Clinical Center Reference Endotoxin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00654134

05-2844 GCRC 2311

NIEHS

US EPA

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Reduced Lung function
• Asthma

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)