A Phase III, multi-center, randomized, controlled study designed to demonstrate the efficacy and safety of Cyclosporine Inhalation Solution (CIS)in improving survival and preventing bronchiolitis obliterans syndrome (BOS) when given prophylactically to lung transplant recipients in addition to their standard immunosuppressive regimen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
284
Cyclosporine (USP) Inhalation Solution; 300mg/4.8 mL in propylene glycol (USP) at a concentration of 62.5 mg/mL; 3 times a week for study duration (up to 3 years)
UCLA School of Medicine
Los Angeles, California, United States
University of California, San Francisco
Duration of BOS-free survival. Other causes for the decline should be excluded by bronchoscopy and other diagnostic testing performed at the discretion of the investigator. The diagnosis of BOS will be determined by the Outcomes Committee
Time frame: Assessed when symptoms of syndrome present
Pulmonary function as measured by mean FEV1 percent predicted at 2 years after randomization
Time frame: From study initiation through 2+ years after randomization
All cause mortality
Time frame: From study initiation through 2+ years after randomization
Duration of event-free survival, corresponding to the length of time between date of randomization and either death or the occurrence of serious bacterial and viral infections that start in the lungs (defined by reporting of a SAE)
Time frame: From study initiation through 2+ year after randomzation
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San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
University of Colorado Health Sciences Center
Denver, Colorado, United States
University of Florida Health Sciences Center
Gainesville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
University of Chicago Hospitals
Chicago, Illinois, United States
Loyola University Hospital
Maywood, Illinois, United States
Indiana Methodist Research Institute
Indianapolis, Indiana, United States
...and 9 more locations