Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz

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Gewählte Publikation:

SHR Neuro Krebs Kardio Lipid Stoffw Microb

Neurohr, C; Kneidinger, N; Ghiani, A; Monforte, V; Knoop, C; Jaksch, P; Parmar, J; Ussetti, P; Sole, A; Müller-Quernheim, J; Kessler, R; Wirtz, H; Boerner, G; Denk, O; Fernandes, SP; Behr, J.
A randomized controlled trial of liposomal cyclosporine A for inhalation in the prevention of bronchiolitis obliterans syndrome following lung transplantation
AM J TRANSPLANT. 2022; 22(1): 222-229. Doi: 10.1111/ajt.16858
Web of Science PubMed FullText FullText_MUG

Führende Autor*innen der Med Uni Graz: Kneidinger Nikolaus
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Abstract:: 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.
Find related publications in this database (Keywords): bronchiolitis obliterans; clinical research/practice; clinical trial; immunosuppressant-calcineurin inhibitor: cyclosporine A (CsA); lung (allograft) function/dysfunction; lung transplantation/pulmonology