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NCT00644514 · ClinicalTrials.gov registry record · Phase 1
Genetics of Asthma - Bronchoscopy Studies
A Phase 1 study, sponsored by John Sundy.
- Terminated
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT00644514: Clinical Trial Phase 1 study, sponsored by John Sundy.
NCT00644514 is a Phase 1 study that was terminated before completion, run by John Sundy. The registered enrollment target is 17 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00644514, a Phase 1 study, was terminated before completion, sponsored by John Sundy.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
The purpose of this study is to identify the mediators and genes in airway epithelial and BAL cells that are differentially regulated following inhalation of endotoxin lipopolysaccharide (LPS) among study participants with allergic asthma and normal phenotypes. This approach is designed to identify novel genes associated with both asthma pathogenesis and asthma susceptibility. LPS, or endotoxin, a cell wall component of gram-negative bacteria, is ubiquitous in the environment, and is thought to influence both susceptibility and severity of asthma. 240 subjects (healthy adult men and women (age \>18-40) with and without atopy and asthma) will complete the screening evaluations in order to establish 3 study groups of 60 subjects each. Each qualified subject will undergo an inhaled LPS endotoxin challenge followed by bronchoscopy after 24 hours, which will consist of a bronchoalveolar lavage (BAL) and endobronchial brush biopsies. BAL involves squirting a small amount of sterile salt water into one of the airways then gently taking it back out through the bronchoscope. The brush sample involves gently moving a small brush back and forth in an airway to collect cell samples. Samples of whole blood will also be obtained at various time points. RNA will be isolated from these cell populations in order to assess differential gene expression expression using microarrays.
Interventions
- BIOLOGICAL Endotoxin - lipopolysaccharide (LPS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2007-09 |
| Est. Completion | 2008-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00644514
The ClinicalTrials.gov registry entry for NCT00644514 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is John Sundy, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Endotoxin - lipopolysaccharide (LPS) is the first listed.
NCT00644514 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00644514 about?
NCT00644514 is a clinical study titled "Genetics of Asthma - Bronchoscopy Studies". The purpose of this study is to identify the mediators and genes in airway epithelial and BAL cells that are differentially regulated following inhalation of endotoxin lipopolysaccharide (LPS) among study participants with allergic asthma and normal phenotypes. This approach is designed to identify ...
What is the current status of trial NCT00644514?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2007-09. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00644514?
The interventions under investigation include: Endotoxin - lipopolysaccharide (LPS) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00644514?
This trial is sponsored by John Sundy, which has 6 total clinical trials registered on ClinicalTrials.gov.
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