drugset / Trial / NCT03657342
Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-1)
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
Outcome
Missed primary endpoint
registry analysis (superiority test); L-CsA treatment plus SoC (FAS) vs SoC alone (FAS); p = 0.7310; LS Mean Difference -0.095 (95% CI -0.405 to 0.214) NCT03657342 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — | — |