Back to Search
Start Over
A randomized controlled trial of liposomal cyclosporine A for inhalation in the prevention of bronchiolitis obliterans syndrome following lung transplantation
- Source :
- Scientia, AMERICAN JOURNAL OF TRANSPLANTATION, r-IIS La Fe. Repositorio Institucional de Producción Científica del Instituto de Investigación Sanitaria La Fe, instname
- Publication Year :
- 2021
-
Abstract
- 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.
- Subjects :
- 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
Subjects
Details
- ISSN :
- 16006143 and 16006135
- Volume :
- 22
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant SurgeonsREFERENCES
- Accession number :
- edsair.doi.dedup.....d1e844776e050376d077309dfc25d2d6