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

This study has been terminated.
(Data collected under different protocol; funding exhuasted)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David B. Peden, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00630461
First received: February 28, 2008
Last updated: October 5, 2012
Last verified: October 2012

February 28, 2008
October 5, 2012
May 2008
May 2012   (final data collection date for primary outcome measure)
Increased sputum neutrophils with no adverse events [ Time Frame: 6 hours post challenge ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00630461 on ClinicalTrials.gov Archive Site
Not Provided
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Safety Study of 20,000 EU of Clinical Center Reference Endotoxin in Allergic Adults With and Without Mild Asthma
Safety Study of 20,000 EU of Clinical Center Reference Endotoxin in Allergic Adults With and Without Mild Asthma

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Mild Allergic Rhinitis
  • Mild Allergic Rhinitis With Mild Asthma
Biological: Clinical Center Reference Endotoxin
single inhalation challenge
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00630461
07-2026 GCRC 2627
No
David B. Peden, MD, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
National Institutes of Health (NIH)
Principal Investigator: David b Peden, MD, MS University of North Carolina
University of North Carolina, Chapel Hill
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP