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

University of North Carolina (UNC)

Status and phase: Terminated; Phase 1

Conditions: Mild Allergic Rhinitis With Mild Asthma; Mild Allergic Rhinitis

Treatments: Biological: Clinical Center Reference Endotoxin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00630461

07-2026 GCRC 2627

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)