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

NCT ID: NCT00654134

Last Updated: 2013-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2013-07-31

Brief Summary

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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

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Conditions

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Healthy Adults

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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Clinical Center Reference Endotoxin

20,000 EU inhaled

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Reduced Lung function
* Asthma
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Environmental Health Sciences (NIEHS)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Michelle Hernandez, MD

Assistant Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michelle Hernandez, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

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Us Epa Hsf

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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US EPA

Identifier Type: -

Identifier Source: secondary_id

NIEHS

Identifier Type: -

Identifier Source: secondary_id

05-2844 GCRC 2311

Identifier Type: -

Identifier Source: org_study_id