Safety Study of 20,000 EU of Clinical Center Reference Endotoxin in Allergic Adults With and Without Mild Asthma

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

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2012-05-31

Brief Summary

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Endotoxin is a component of outdoor air pollution, an air contaminant found in a number of different workplaces, and is even found in homes. The endotoxin used for this study is obtained from the National Institutes of Health, and is called "Clinical Center Reference Endotoxin", or CCRE. The purpose of this Phase 1 research study is to identify a dose of inhaled endotoxin that is safe (does not cause prolonged cough, shortness of breath or other problems), but causes changes in your sputum cell samples that the scientists can measure. Phase 1 research studies like this one are not intended to be a treatment, but are a scientific investigation. Eventually, with these types of studies we will be able to examine why some people are more sensitive to endotoxin. Scientists at other universities have found that while most people do not have a considerable lung response to endotoxin at doses as high as 60,000 EU (endotoxin units), a few respond to as little as a total dose of 4500 EU. Our study is designed to identify if using a dose of 20,000 EU causes changes in the lung cells but does not cause symptoms in our study subjects. In our previous studies in our lab, using an endotoxin from another source, we have used higher doses (15,000 EUs) in subjects with asthma with no major problems, and we have used 10,000 EUs of CCRE in subjects with allergies and asthma without problems. We have used 20,000 EUs of CCRE in healthy individuals with no major problems.

Detailed Description

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Conditions

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Mild Allergic Rhinitis Mild Allergic Rhinitis With Mild Asthma

Keywords

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mild asthma, mild allergies

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

single inhalation challenge

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Mild allergic rhinitis
* Mild allergic asthma
* Normal lung function
* No other chronic illness

Exclusion Criteria

* Use of inhaled or oral steroids
* Emergency treatment of asthma in last year
* Inhaled tobacco use

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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David B. Peden, MD

Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David b Peden, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

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UNC Center for Environmental Medicine, Asthma and Lung Biology

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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07-2026 GCRC 2627

Identifier Type: -

Identifier Source: org_study_id