drugset / Trial / NCT01334892

L-CsA in the Prevention of Bronchiolitis Obliterans Syndrome (BOS) in Lung Transplant (LT) Patients

NCT01334892

Phase 2/3 Terminated 130 enrolled Pari Pharma GmbH
RandomizedParallel-groupQuadruple-blindPrevention

Summary

Immunosuppression is a key intervention in patients with solid organ transplant and is usually achieved by combination therapy with systemic CsA or tacrolimus with azathioprine, mycophenolate mofetil (MMF), or corticoids. However, the outcomes after lung transplantation are poor when compared with those after heart, kidney, or liver transplantation, with a survival rate of only 55% for recipients of lung transplants. Additional application of aerosolised L-CsA should suppress T-cell activation in the lung tissue and subsequently BOS development. The overall purpose of this phase-II/III study is to obtain efficacy and safety data of L-CsA in the prevention of BOS.

Timeline

Start
2009-12
Primary completion
2013-07
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cyclosporine Peptide 2.5 ml Inhaled
Comparator Cyclosporine Peptide 10 mg Inhaled