Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Double Lung Transplant (BOSTON-2)

Summary

The objective of this trial was to assess the efficacy and safety of aerosolized liposomal cyclosporine A (L-CsA) as add-on therapy to standard of care (SoC) as compared to SoC alone in double lung transplant (DLT) recipients with chronic lung allograft dysfunction (CLAD)-bronchiolitis obliterans syndrome (BOS).

Timeline

Start

2019-03-26

Primary completion

2024-03-12

Completion

2024-03-12

Outcome

Missed primary endpoint

registry analysis (superiority test); L-CsA Treatment Plus SoC - FAS vs Standard of Care - FAS; p = 0.6639; least square mean difference -0.028 (95% CI -0.160 to 0.104) NCT03656926 ↗

Drugs

Indications