A randomised single-centre trial of inhaled liposomal cyclosporine for bronchiolitis obliterans syndrome post-lung transplantation

• Published in: ERJ open research 2019-10, Vol.5 (4), p.167
• Main Authors: Iacono, Aldo, Wijesinha, Marniker, Rajagopal, Keshava, Murdock, Natalia, Timofte, Irina, Griffith, Bartley, Terrin, Michael
• Format: Article
• Language: English
• ISSN: 2312-0541; 2312-0541
• DOI: 10.1183/23120541.00167-2019

No proven treatments exist for bronchiolitis obliterans syndrome (BOS) following lung transplantation. Inhaled liposomal cyclosporine (L-CsA) may prevent BOS progression. A 48-week phase IIb randomised clinical trial was conducted in 21 lung transplant patients with BOS assigned to either L-CsA with standard-of-care (SOC) oral immunosuppression (L-CsA group) or SOC (SOC-alone group). Efficacy end-points were BOS progression-free survival (defined as absence of ≥20% decline in forced expiratory volume in 1 s (FEV ) from randomisation, re-transplantation or death) and BOS grade change. BOS progression-free survival was 82% for L-CsA 50% for SOC-alone (p=0.1) and BOS grade worsened in 18% for L-CsA 60% for SOC-alone (p=0.05). Mean changes in ΔFEV and forced vital capacity, respectively, stabilised with L-CsA: +0.005 (95% CI -0.004- +0.013) and -0.005 (95% CI -0.015- +0.006) L·month , but worsened with SOC-alone: -0.023 (95% CI -0.033- -0.013) and -0.026 (95% CI -0.039- -0.014) L·month (p