NCT00654134

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2005

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2008

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

August 9, 2013

Status Verified

August 1, 2013

Enrollment Period

7.8 years

First QC Date

April 1, 2008

Last Update Submit

August 6, 2013

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Clinical Center Reference EndotoxinBIOLOGICAL

20,000 EU inhaled

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Reduced Lung function
  • Asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Us Epa Hsf

Chapel Hill, North Carolina, 27599, United States

Location

Study Officials

  • Michelle Hernandez, MD

    University of North Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

April 1, 2008

First Posted

April 7, 2008

Study Start

October 1, 2005

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

August 9, 2013

Record last verified: 2013-08

Locations

US(1)