220
Participants
Start Date
April 2, 2019
Primary Completion Date
April 16, 2024
Study Completion Date
April 16, 2024
Liposomal Cyclosporine A
This formulation is developed for inhalation use and delivered via the PARI eFlow® Device, which is a new technology of nebulizing liquid drugs with a perforated vibrating membrane resulting in an aerosol with a low ballistic momentum and a high percentage of droplets in a respirable size range of 3-5 μm
standard of care
Standard of Care Therapy. Eligible patients should be on a maintenance regimen of immunosuppressive agents including tacrolimus, a second agent such as but not limited to MMF or azathioprine, and a systemic corticosteroid such as prednisone as third agent. The regimen must be stable within 4 weeks prior to randomization with respect to the therapeutic agents. Patients receiving azithromycin for prophylaxis or treatment of BOS, must be on a stable regimen for a least 4-weeks prior to randomization and will continue to receive azithromycin during the trial as deemed appropriate by the investigator.
Universitair Ziekenhuis Leuven, Leuven
Columbia University Medical Center, New York
Hospital C.H.U.A.C., A Coruña
University of Pittsburgh Medical Center, Pittsburgh
Temple University Hospital, Philadelphia
University of Maryland, Baltimore
Johns Hopkins University Hospital, Baltimore
Duke University Medical Center, Durham
Mayo Clinic Jacksonville, Jacksonville
University of Florida Medical Center, Gainesville
University of South Florida, Tampa
University of Kentucky Albert B. Chandler Hospital, Lexington
Ohio State University Medical Center, Columbus
Cleveland Clinic, Cleveland
Indiana University Health Methodist Hospital, Indianapolis
Barnes-Jewish Hospital, St Louis
Baylor University Medical Center, Dallas
University of Texas Southwestern Medical Center, Dallas
Baylor St. Luke's Medical Center, Houston
Houston Methodist Hospital, Houston
Banner Health, Phoenix
UCLA Medical Center, Los Angeles
UC San Francisco, San Francisco
Stanford University Hospital, Palo Alto
Hôpitaux Universitaires de Strasbourg, Strasbourg
Hannover Medical School - MHH Klinik für Pneumologie, Hanover
LMU Klinikum Großhadern, Munich
Rabin Medical Center, Petah Tikva
Complexo Hospitalario de A Coruna, A Coruña
Hospital Universitari Vall d'Hebron, Barcelona
Hospital Universitario Puerta de Hierro, Madrid
Hospital Marques de Valdecilla, Santander
Hospital Universitario y Politécnico La Fe, Valencia
Royal Papworth Hospital NHS Foundation Trust, Cambridge
University Hospital of South Manchester NHS Foundation Trust, Manchester
Wythenshawe Hospital - Cardiothoracic Transplant Unit, Manchester
Zambon SpA
INDUSTRY