A randomized controlled trial of liposomal cyclosporine A for inhalation in the prevention of bronchiolitis obliterans syndrome following lung transplantation

Autor: Romain Kessler, Nikolaus Kneidinger, Piedad Ussetti, Amparo Solé, Jasvir Parmar, Juergen Behr, Joachim Müller-Quernheim, Peter Jaksch, Stefanie Prante Fernandes, Christiane Knoop, Hubert Wirtz, Víctor Monforte, Alessandro Ghiani, Gerhard Boerner, Oliver Denk, Claus Neurohr
Přispěvatelé: Institut Català de la Salut, [Neurohr C] Department of Medicine V, University Hospital, LMU Munich, German Center for Lung Research (DZL), Munich, Germany. Department of Pulmonology and Respiratory Medicine, Robert-Bosch-Krankenhaus Stuttgart, Stuttgart, Germany. [Kneidinger N] Department of Medicine V, University Hospital, LMU Munich, German Center for Lung Research (DZL), Munich, Germany. [Ghiani A] Department of Pulmonology and Respiratory Medicine, Robert-Bosch-Krankenhaus Stuttgart, Stuttgart, Germany. [Monforte V] Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Knoop C] CHU Erasme Université Libre de Bruxelles, Brussel, Belgium. [Jaksch P] Department of Thoracic Surgery, Medical University of Vienna, Vienna, Austria, Vall d'Hebron Barcelona Hospital Campus
Rok vydání: 2021
Předmět:
medicine.medical_specialty
Otros calificadores::Otros calificadores::/prevención & control [Otros calificadores]
medicine.medical_treatment
cyclosporine A (CsA)
lung (allograft) function/dysfunction
lung transplantation/pulmonology [bronchiolitis obliterans
clinical research/practice
clinical trial
immunosuppressant - calcineurin inhibitor]
Bronchiolitis obliterans
Placebo
law.invention
Other subheadings::Other subheadings::/prevention & control [Other subheadings]
Randomized controlled trial
law
Internal medicine
Administration
Inhalation
medicine
Clinical endpoint
Immunology and Allergy
Lung transplantation
Humans
Pharmacology (medical)
enfermedades respiratorias::enfermedades bronquiales::bronquitis::bronquiolitis::bronquiolitis obliterante [ENFERMEDADES]
Bronchiolitis Obliterans
Lung
Transplantation
Intention-to-treat analysis
Inhalation
business.industry
Teràpia respiratòria
Immunosuppression
Respiratory Tract Diseases::Bronchial Diseases::Bronchitis::Bronchiolitis::Bronchiolitis Obliterans [DISEASES]
medicine.disease
Cyclosporine
Bronquiolitis - Tractament
business
Lung Transplantation
Zdroj: Scientia
AMERICAN JOURNAL OF TRANSPLANTATION
r-IIS La Fe. Repositorio Institucional de Producción Científica del Instituto de Investigación Sanitaria La Fe
instname
ISSN: 1600-6143
1600-6135
Popis: Bronchiolitis obliterans; Clinical research; Lung transplantation Bronquiolitis obliterante; Investigación clínica; Trasplante de pulmón Bronquiolitis obliterant; Recerca clínica; Trasplantament de pulmó Long-term survival after lung transplantation is limited by chronic allograft dysfunction. The aim of this study was to investigate the effect of locally augmented immunosuppression with liposomal cyclosporine A for inhalation (L-CsA-i) for the prevention of bronchiolitis obliterans syndrome (BOS). In a randomized, double-blind, placebo-controlled, multi-center Phase 3 study, 180 LT recipients in BOS grade 0 were planned to receive L-CsA-i or placebo in addition to triple-drug immunosuppression. L-CsA-i was administered twice daily via an Investigational eFlow nebulizer to recipients of single (SLT) and bilateral lung transplants (BLT) within 6–32 weeks posttransplant, and continued for 2 years. The primary endpoint was BOS-free survival. 130 patients were enrolled before the study was prematurely terminated for business reasons. Despite a 2-year actuarial difference in BOS-free survival of 14.1% in favor of L-CsA-i in the overall study population, the primary endpoint was not met (p = .243). The pre-defined per protocol analysis of SLT recipients (n = 24) resulted in a treatment difference of 58.2% (p = .053). No difference was observed in the BLT (n = 48) subpopulation (p = .973). L-CsA-i inhalation was well tolerated. Although this study failed to meet its primary endpoint, the results warrant additional investigation of L-CsA-i in lung transplant recipients. The study was funded by PARI Pharma GmbH. Open access funding enabled and organized by ProjektDEAL.
Databáze: OpenAIRE
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