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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: Completed Phase 4 study, sponsored by Duke University.
NCT01469364 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 30 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Within-subject change to absolute FEV1 month 1 vs. 0. FEV1 was measured 14-35 days after the start of months 1 AZLI courses and compared to study month 0 (baseline/prior to 1st dose).
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 |
What the finished NCT01469364 record still lists
NCT01469364 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Aztreonam Lysine for Inhalation (AZLI) is the first listed.
NCT01469364 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01469364's enrollment target sits among peer trials
30 1552nd of 2000 higher than 367 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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