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

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    Author
    Iacono, A.
    Wijesinha, M.
    Murdock, N.
    Timofte, I.
    Griffith, B.
    Terrin, M.
    Date
    2019
    Journal
    ERS Monograph
    Publisher
    European Respiratory Society
    Type
    Article
    
    Metadata
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    See at
    https://doi.org/10.1183/23120541.00167-2019
    Abstract
    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.
    Sponsors
    Graduate School, University of Maryland
    Keyword
    Bronchiolitis Obliterans
    Cyclosporine
    Lung Transplantation
    Identifier to cite or link to this item
    https://www.scopus.com/inward/record.uri?eid=2-s2.0-85077639889&doi=10.1183%2f23120541.00167-2019&partnerID=40&md5=5eff60907680bac3b5e679c6dfd768e5; http://hdl.handle.net/10713/11691
    ae974a485f413a2113503eed53cd6c53
    10.1183/23120541.00167-2019
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