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

Bronchiolitis obliterans; Clinical research; Lung transplantation

Detalhes bibliográficos
Autores: Neurohr, Claus, Kneidinger, Nikolaus, Ghiani, Alessandro, Monforte Torres, Victor, Knoop, Christiane, Jaksch, Peter
Tipo de documento: artigo
Estado:Versão publicada
Data de publicação:2022
País:España
Recursos:Departament de Salut de la Generalitat de Catalunya (DS)
Repositório:Scientia. Dipòsit d'Informació Digital del Departament de Salut
OAI Identifier:oai:scientiasalut.gencat.cat:11351/7817
Acesso em linha:https://hdl.handle.net/11351/7817
Access Level:Acceso aberto
Palavra-chave:Teràpia respiratòria
Bronquiolitis - Tractament
DISEASES::Respiratory Tract Diseases::Bronchial Diseases::Bronchitis::Bronchiolitis::Bronchiolitis Obliterans
Other subheadings::Other subheadings::Other subheadings::/prevention & control
ENFERMEDADES::enfermedades respiratorias::enfermedades bronquiales::bronquitis::bronquiolitis::bronquiolitis obliterante
Otros calificadores::Otros calificadores::Otros calificadores::/prevención & control
id ES_01e33dc8d4d1e890c913a44e2d25f7fb
oai_identifier_str oai:scientiasalut.gencat.cat:11351/7817
network_acronym_str ES
network_name_str España
repository_id_str
spelling A randomized controlled trial of liposomal cyclosporine A for inhalation in the prevention of bronchiolitis obliterans syndrome following lung transplantationNeurohr, ClausKneidinger, NikolausGhiani, AlessandroMonforte Torres, VictorKnoop, ChristianeJaksch, PeterTeràpia respiratòriaBronquiolitis - TractamentDISEASES::Respiratory Tract Diseases::Bronchial Diseases::Bronchitis::Bronchiolitis::Bronchiolitis ObliteransOther subheadings::Other subheadings::Other subheadings::/prevention & controlENFERMEDADES::enfermedades respiratorias::enfermedades bronquiales::bronquitis::bronquiolitis::bronquiolitis obliteranteOtros calificadores::Otros calificadores::Otros calificadores::/prevención & controlBronchiolitis obliterans; Clinical research; Lung transplantationBronquiolitis obliterante; Investigación clínica; Trasplante de pulmónBronquiolitis obliterant; Recerca clínica; Trasplantament de pulmóLong-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.WileyInstitut 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, AustriaVall d'Hebron Barcelona Hospital Campus202220222022info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/11351/7817Scientiareponame:Scientia. Dipòsit d'Informació Digital del Departament de Salutinstname:Departament de Salut de la Generalitat de Catalunya (DS)InglésAmerican Journal of Transplantation;22(1)https://doi.org/10.1111/ajt.16858Attribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:scientiasalut.gencat.cat:11351/78172026-06-12T09:38:37Z
dc.title.none.fl_str_mv A randomized controlled trial of liposomal cyclosporine A for inhalation in the prevention of bronchiolitis obliterans syndrome following lung transplantation
title A randomized controlled trial of liposomal cyclosporine A for inhalation in the prevention of bronchiolitis obliterans syndrome following lung transplantation
spellingShingle A randomized controlled trial of liposomal cyclosporine A for inhalation in the prevention of bronchiolitis obliterans syndrome following lung transplantation
Neurohr, Claus
Teràpia respiratòria
Bronquiolitis - Tractament
DISEASES::Respiratory Tract Diseases::Bronchial Diseases::Bronchitis::Bronchiolitis::Bronchiolitis Obliterans
Other subheadings::Other subheadings::Other subheadings::/prevention & control
ENFERMEDADES::enfermedades respiratorias::enfermedades bronquiales::bronquitis::bronquiolitis::bronquiolitis obliterante
Otros calificadores::Otros calificadores::Otros calificadores::/prevención & control
title_short A randomized controlled trial of liposomal cyclosporine A for inhalation in the prevention of bronchiolitis obliterans syndrome following lung transplantation
title_full A randomized controlled trial of liposomal cyclosporine A for inhalation in the prevention of bronchiolitis obliterans syndrome following lung transplantation
title_fullStr A randomized controlled trial of liposomal cyclosporine A for inhalation in the prevention of bronchiolitis obliterans syndrome following lung transplantation
title_full_unstemmed A randomized controlled trial of liposomal cyclosporine A for inhalation in the prevention of bronchiolitis obliterans syndrome following lung transplantation
title_sort A randomized controlled trial of liposomal cyclosporine A for inhalation in the prevention of bronchiolitis obliterans syndrome following lung transplantation
dc.creator.none.fl_str_mv Neurohr, Claus
Kneidinger, Nikolaus
Ghiani, Alessandro
Monforte Torres, Victor
Knoop, Christiane
Jaksch, Peter
author Neurohr, Claus
author_facet Neurohr, Claus
Kneidinger, Nikolaus
Ghiani, Alessandro
Monforte Torres, Victor
Knoop, Christiane
Jaksch, Peter
author_role author
author2 Kneidinger, Nikolaus
Ghiani, Alessandro
Monforte Torres, Victor
Knoop, Christiane
Jaksch, Peter
author2_role author
author
author
author
author
dc.contributor.none.fl_str_mv 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
dc.subject.none.fl_str_mv Teràpia respiratòria
Bronquiolitis - Tractament
DISEASES::Respiratory Tract Diseases::Bronchial Diseases::Bronchitis::Bronchiolitis::Bronchiolitis Obliterans
Other subheadings::Other subheadings::Other subheadings::/prevention & control
ENFERMEDADES::enfermedades respiratorias::enfermedades bronquiales::bronquitis::bronquiolitis::bronquiolitis obliterante
Otros calificadores::Otros calificadores::Otros calificadores::/prevención & control
topic Teràpia respiratòria
Bronquiolitis - Tractament
DISEASES::Respiratory Tract Diseases::Bronchial Diseases::Bronchitis::Bronchiolitis::Bronchiolitis Obliterans
Other subheadings::Other subheadings::Other subheadings::/prevention & control
ENFERMEDADES::enfermedades respiratorias::enfermedades bronquiales::bronquitis::bronquiolitis::bronquiolitis obliterante
Otros calificadores::Otros calificadores::Otros calificadores::/prevención & control
description Bronchiolitis obliterans; Clinical research; Lung transplantation
publishDate 2022
dc.date.none.fl_str_mv 2022
2022
2022
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/11351/7817
url https://hdl.handle.net/11351/7817
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv American Journal of Transplantation;22(1)
https://doi.org/10.1111/ajt.16858
dc.rights.none.fl_str_mv Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Wiley
publisher.none.fl_str_mv Wiley
dc.source.none.fl_str_mv Scientia
reponame:Scientia. Dipòsit d'Informació Digital del Departament de Salut
instname:Departament de Salut de la Generalitat de Catalunya (DS)
instname_str Departament de Salut de la Generalitat de Catalunya (DS)
reponame_str Scientia. Dipòsit d'Informació Digital del Departament de Salut
collection Scientia. Dipòsit d'Informació Digital del Departament de Salut
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869402616308432896
score 15,812429

Registros relacionados