drugset / Trial / NCT04039347

Extension Trial on Efficacy / Safety of L-CsA + SoC in Treating BOS in Post Single or Double Lung Transplant (BOSTON-3)

NCT04039347 ↗

Phase 3 Terminated 164 enrolled Zambon SpA
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The objective of the trial is to assess the long-term safety and efficacy of L-CsA plus Standard of Care (SoC) in the treatment of BOS in single (SLT) and double lung transplant (DLT) recipients.

Timeline

Start
2020-03-12
Primary completion
2026-02-25
Completion
2026-02-25

Outcome

Outcome not reported

Stopped (Business): “Study was terminated for business reasons. The earlier study end is not related to any safety concerns or data issues identified at any site or within the overall study data collected to date.”

Drugs

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