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NCT01469364 · ClinicalTrials.gov registry record · Phase 4
Safety Study of Aztreonam Lysine for Inhalation (AZLI) in the Treatment of Early Bronchiolitis Obliterans Syndrome (BOS)
A Phase 4 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT01469364 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 30 participants.
The verdict
NCT01469364, a Phase 4 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
Study Summary
This study is a pilot two- center study to determine if aztreonam lysine for inhalation AZLI can be safely and self-administered in lung transplant recipients with newly diagnosed bronchiolitis obliterans syndrome, grade 1 (BOS) and obtain pilot data regarding its effect on lung function in order to appropriately design and power a larger multicenter randomized study. The hypothesis is that AZLI is a safe and effective treatment for declining lung function in lung transplant recipients with early stage BOS.
Interventions
- DRUG Aztreonam Lysine for Inhalation (AZLI)
- PROCEDURE Status Post Lung Transplant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2013-03 |
| Est. Completion | 2015-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01469364
The ClinicalTrials.gov registry entry for NCT01469364 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Aztreonam Lysine for Inhalation (AZLI) is the first listed.
NCT01469364 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01469364 about?
NCT01469364 is a clinical study titled "Safety Study of Aztreonam Lysine for Inhalation (AZLI) in the Treatment of Early Bronchiolitis Obliterans Syndrome (BOS)". This study is a pilot two- center study to determine if aztreonam lysine for inhalation AZLI can be safely and self-administered in lung transplant recipients with newly diagnosed bronchiolitis obliterans syndrome, grade 1 (BOS) and obtain pilot data regarding its effect on lung function in order to...
What is the current status of trial NCT01469364?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2013-03. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01469364?
The interventions under investigation include: Aztreonam Lysine for Inhalation (AZLI) (DRUG), Status Post Lung Transplant (PROCEDURE).
Who is sponsoring clinical trial NCT01469364?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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