drugset / Trial / NCT04107675

A Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis After Hematopoietic Transplant (BOSTON-4)

NCT04107675

Phase 2 Terminated 6 enrolled Zambon SpA
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

EvaluationDrugModalityDoseRoute
Subject Cyclosporine Peptide 5 mg Inhaled
Subject Cyclosporine Peptide 10 mg Inhaled