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NCT00630461 · ClinicalTrials.gov registry record · Phase 1
Safety Study of 20,000 EU of Clinical Center Reference Endotoxin in Allergic Adults With and Without Mild Asthma
A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT00630461 is a Phase 1 study that was terminated before completion, run by University of North Carolina, Chapel Hill. The registered enrollment target is 4 participants.
The verdict
NCT00630461, a Phase 1 study, was terminated before completion, sponsored by University of North Carolina, Chapel Hill.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study 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.
Interventions
- BIOLOGICAL Clinical Center Reference Endotoxin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2008-05 |
| Est. Completion | 2012-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00630461
The ClinicalTrials.gov registry entry for NCT00630461 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Clinical Center Reference Endotoxin is the first listed.
NCT00630461 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00630461 about?
NCT00630461 is a clinical study titled "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...
What is the current status of trial NCT00630461?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2008-05. Estimated completion is 2012-05.
What interventions are being tested in trial NCT00630461?
The interventions under investigation include: Clinical Center Reference Endotoxin (BIOLOGICAL).
Who is sponsoring clinical trial NCT00630461?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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