drugset / Trial / NCT04107675
A Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis After Hematopoietic Transplant (BOSTON-4)
RandomizedParallel-groupSingle-blindTreatment
Summary
Primary Objective: The primary objective of this study is to assess the tolerability and safety of two dose levels of aerosolized L-CsA vs placebo in addition to SoC therapy for BOS in adult allo-HSCT recipients. Secondary Objectives: The secondary objectives of this study are to assess PK and exploratory efficacy and quality of life of two dose levels of aerosolized L-CsA vs placebo in addition to SoC therapy for BOS in adult allo-HSCT recipients.
Timeline
- Start
- 2020-02-11
- Primary completion
- 2022-06-16
- Completion
- 2022-12-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclosporine | Peptide | 5 mg | Inhaled |
| Subject | Cyclosporine | Peptide | 10 mg | Inhaled |