Safety Study of Aztreonam Lysine for Inhalation (AZLI) in the Treatment of Early Bronchiolitis Obliterans Syndrome (BOS)

Completed · Phase 4

Conditions studied: Complication of Transplanted Lung

In brief

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.

Key facts

Study ID

NCT01469364

Run by

Duke University

People needed

30

Starts

2013-03-01

Expected to finish

2015-04-01

Last updated by the study team

2016-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult (18 or older at the time of transplant) male or female
• Cadaveric first lung transplant recipient, single or bilateral; or multi-organ lung transplant recipient.
• Current FEV1 66-80% of posttransplant baseline FEV1, and meets all criteria for BOS 1 as defined by the International Society of Heart and Lung Transplantation.
• Onset of BOS 1 within twelve months of screening

You may not qualify if…

• Known allergy to aztreonam
• Retransplant
• Pediatric patients
• Live lobar transplant recipients
• Inability to provide informed consent.
• Patients with advanced BOS (grades 2,3) or established BOS >6 months
• Pregnant Women

Where it is running

• David Geffen School of Medicine at UCLA — Los Angeles, California, United States
• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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