Overview

A Clinical Trial to Demonstrate the Efficacy and Safety of Liposomal Cyclosporine A Inhalation Solution in the Treatment of CLAD/Bronchiolitis Obliterans Syndrome in Patients Post Double Lung Transplant

Status:
Recruiting

Trial end date:
2023-07-01

Target enrollment:

Participant gender:

Summary

This is a Phase III randomized, controlled clinical trial of L-CsA for the treatment of bronchiolitis obliterans syndrome in adults diagnosed with BOS following double lung transplant. Patients will receive either L-CsA (10 mg) via the PARI Investigational eFlow® Device twice daily plus Standard of Care (SoC) treatment, or SoC alone, for a period of 48 weeks. All patients will be eligible to continue in an open-label extension trial of L-CsA following completion of BOSTON-2.

Phase:

Phase 3

Details

Lead Sponsor:

Breath Therapeutics Inc.
Zambon SpA

Treatments:

Cyclosporine
Cyclosporins