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

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: Gilead Sciences
• Treatments: Aztreonam

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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