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

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ClinicalTrials.gov Identifier: NCT00630461
Recruitment Status : Terminated (Data collected under different protocol; funding exhuasted)
First Posted : March 7, 2008
Last Update Posted : October 8, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mild Allergic Rhinitis Mild Allergic Rhinitis With Mild Asthma Biological: Clinical Center Reference Endotoxin Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Safety Study of 20,000 EU of Clinical Center Reference Endotoxin in Allergic Adults With and Without Mild Asthma
Study Start Date : May 2008
Primary Completion Date : May 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Biological: Clinical Center Reference Endotoxin
    single inhalation challenge

Outcome Measures

Primary Outcome Measures :
  1. Increased sputum neutrophils with no adverse events [ Time Frame: 6 hours post challenge ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00630461

United States, North Carolina
UNC Center for Environmental Medicine, Asthma and Lung Biology
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institutes of Health (NIH)
Principal Investigator: David b Peden, MD, MS University of North Carolina
More Information

Responsible Party: David B. Peden, MD, Professor of Pediatrics, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00630461     History of Changes
Other Study ID Numbers: 07-2026 GCRC 2627
First Posted: March 7, 2008    Key Record Dates
Last Update Posted: October 8, 2012
Last Verified: October 2012

Keywords provided by David B. Peden, MD, University of North Carolina, Chapel Hill:
mild asthma, mild allergies

Additional relevant MeSH terms:
Rhinitis, Allergic
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases