Liposomal Cyclosporine A

Status
Phase 3
Condition
Lung Transplant
Intervention Type
Inhaled Drug
Funder Type
Industry

Drug Details

Liposomal Cyclosporine A for inhalation (L-CsA-i) is a true liposome of cyclosporine A designed for inhaled delivery to the lungs (administered via the high-performance PARI eFlow® Nebulizer System)

Study Purpose

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 single lung transplant. Patients will receive either L-CsA (5 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-1.

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