CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 30 enrolled
Drug / intervention
Aztreonam Lysine for Inhalation (AZLI) +1 moredrug
Likely dose
Aztreonam Lysine for Inhalation (AZLI) 75mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01469364
NCT01469364Phase 4Completed
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Aztreonam Lysine for Inhalation (AZLI) in the Treatment of Early Bronchiolitis Obliterans Syndrome (BOS) After Lung Transplantation

Duke University·interventional·Posted Nov 10, 2011·Updated Jan 29, 2016

In Brief

A Phase 4 clinical trial evaluating Aztreonam Lysine for Inhalation (AZLI) and Status Post Lung Transplant for Complication of Transplanted Lung. Completed, enrolled 30 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsComplication of Transplanted Lung
CountriesUnited States
CollaboratorsGilead Sciences

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 10, 2011
Enrollment StartMar 1, 2013
Primary CompletionMar 1, 2015
Study CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 14.6 years ago

Interventions

Aztreonam Lysine for Inhalation (AZLI)drug

The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)

Status Post Lung Transplantprocedure

Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care.