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

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

Fecha de publicación: Fecha Ahead of Print:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Neurohr, Claus
  • Kneidinger, Nikolaus
  • Ghiani, Alessandro
  • Monforte, Victor
  • Knoop, Christiane
  • Jaksch, Peter
  • Parmar, Jasvir
  • Ussetti, Piedad
  • Müller-Quernheim J
  • Kessler, Romain
  • Wirtz, Hubert
  • Boerner, Gerhard
  • Denk, Oliver
  • Prante Fernandes S
  • Behr, Juergen

Grupos

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.

© 2021 The Authors. American Journal of Transplantation published by Wiley Periodicals LLC on behalf of The American Society of Transplantation and the American Society of Transplant Surgeons.

Datos de la publicación

ISSN/ISSNe:
1600-6135, 1600-6143

AMERICAN JOURNAL OF TRANSPLANTATION  ELSEVIER SCIENCE INC

Tipo:
Article
Páginas:
222-229
PubMed:
34587371
Factor de Impacto:
3,311 SCImago ℠
Cuartil:
Q1 SCImago ℠

Citas Recibidas en Web of Science: 22

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Keywords

  • bronchiolitis obliterans, clinical research/practice, clinical trial, immunosuppressant - calcineurin inhibitor: cyclosporine A (CsA), lung (allograft) function/dysfunction, lung transplantation/pulmonology

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