Status:
COMPLETED
Safety Study of Aztreonam Lysine for Inhalation (AZLI) in the Treatment of Early Bronchiolitis Obliterans Syndrome (BOS)
Lead Sponsor:
Duke University
Collaborating Sponsors:
Gilead Sciences
Conditions:
Complication of Transplanted Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 oblite...
Detailed Description
Lung transplantation is increasingly employed as a therapy for patients with advanced lung disease including cystic fibrosis, idiopathic pulmonary fibrosis or emphysema. Despite significant short-term...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01469364
Start Date
March 1 2013
End Date
April 1 2015
Last Update
January 29 2016
Active Locations (2)
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1
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
2
Duke University Medical Center
Durham, North Carolina, United States, 27710