TY - JOUR T1 - A randomised single-centre trial of inhaled liposomal cyclosporine for bronchiolitis obliterans syndrome post-lung transplantation JF - ERJ Open Research JO - erjor DO - 10.1183/23120541.00167-2019 VL - 5 IS - 4 SP - 00167-2019 AU - Aldo Iacono AU - Marniker Wijesinha AU - Keshava Rajagopal AU - Natalia Murdock AU - Irina Timofte AU - Bartley Griffith AU - Michael Terrin Y1 - 2019/10/01 UR - http://openres.ersjournals.com/content/5/4/00167-2019.abstract N2 - Introduction No proven treatments exist for bronchiolitis obliterans syndrome (BOS) following lung transplantation. Inhaled liposomal cyclosporine (L-CsA) may prevent BOS progression.Methods 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 (FEV1) from randomisation, re-transplantation or death) and BOS grade change.Results BOS progression-free survival was 82% for L-CsA versus 50% for SOC-alone (p=0.1) and BOS grade worsened in 18% for L-CsA versus 60% for SOC-alone (p=0.05). Mean changes in ΔFEV1 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−1, but worsened with SOC-alone: −0.023 (95% CI −0.033– −0.013) and −0.026 (95% CI −0.039– −0.014) L·month−1 (p<0.0001 and p=0.009). Median survival (4.1 versus 2.9 years; p=0.03) and infection rate (45% versus 60%; p=0.7) improved with L-CsA versus SOC-alone; creatinine and tacrolimus levels were similar.Conclusions L-CsA was well tolerated and stabilised lung function in lung transplant recipients affected by BOS without systemic toxicity, providing a basis for a global phase III trial using L-CsA.Liposomal aerosol cyclosporine (L-CsA) was well tolerated and stabilised lung function in lung transplant recipients affected by BOS. The data provide evidence for an ongoing global phase III trial using L-CsA for BOS. http://bit.ly/2HB8w5j ER -