Study of Cyclosporine Inhalation Solution (CIS) in Improving Bronchiolitis Obliterans Syndrome-Free Survival Following Lung Transplantation
- Registration Number
- NCT00755781
- Lead Sponsor
- APT Pharmaceuticals, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 284
- A recipient of a single or double lung transplant (including heart-lung transplant)
- Age 18 years or older
- Able to produce a forced expiratory volume in one second (FEV1) of greater than one liter at randomization
- Eligible subjects must be enrolled within 70 days after receiving a lung transplant
- Clinical status sufficiently stable to enable routine post-transplant bronchoscopy with bronchoalveolar lavage (BAL) and chest X-ray (or equivalent i.e., chest computerized tomogram (CT)) prior to screening
- Lung re-transplantation
- Documented allergy to propylene glycol and/or cyclosporine
- Documented respiratory or anastomotic infections unless on appropriate antimicrobial therapy with evidence of clinical response
- Women who are pregnant, wishing to become pregnant, or unwilling to use appropriate birth control to avoid becoming pregnant
- Women who are breastfeeding
- Clinically significant bronchial stenosis unresponsive to dilation and/or stenting
- Malignancies diagnosed within one year prior to screening (with the exception of non-melanomatous skin cancers)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CIS Cyclosporine Inhalation Solution (CIS) CIS in addition to standard immunosuppressive regimen.
- Primary Outcome Measures
Name Time Method 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 Assessed when symptoms of syndrome present
- Secondary Outcome Measures
Name Time Method Pulmonary function as measured by mean FEV1 percent predicted at 2 years after randomization From study initiation through 2+ years after randomization All cause mortality 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) From study initiation through 2+ year after randomzation
Trial Locations
- Locations (19)
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
University of Florida Health Sciences Center
🇺🇸Gainesville, Florida, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
New York Presbyterian Hospital, Columbia University Med. Ctr.
🇺🇸New York, New York, United States
UCLA School of Medicine
🇺🇸Los Angeles, California, United States
University of Chicago Hospitals
🇺🇸Chicago, Illinois, United States
Loyola University Hospital
🇺🇸Maywood, Illinois, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
University of Colorado Health Sciences Center
🇺🇸Denver, Colorado, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
University of Toronto
🇨🇦Toronto, Ontario, Canada
Indiana Methodist Research Institute
🇺🇸Indianapolis, Indiana, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States