drugset / Trial / NCT03657342

Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-1)

NCT03657342

Phase 3 Completed 62 enrolled Zambon SpA
RandomizedParallel-groupSingle-blindTreatment

Summary

The objective of this trial is 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 single lung transplant recipients with chronic lung allograft dysfunction (CLAD)-bronchiolitis obliterans syndrome (BOS).

Timeline

Start
2019-03-26
Primary completion
2024-04-16
Completion
2024-04-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Liposomal Cyclosporine A Unknown 5 mg Inhaled
Comparator Azathioprine Small molecule
Comparator Azithromycin Small molecule
Comparator MMF Unknown
Comparator Prednisone Other / unclassified
Comparator Tacrolimus Small molecule