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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase II, Multicentre, Randomised, Double-blind, Placebo Controlled Clinical Trial to Investigate the Efficacy and Safety of Aerosolised Liposomal Ciclosporin A Versus Aerosolised Placebo in the Pre

Brief 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.


Detailed Summary: Preventive therapeutic intervention by L-CsA is primarily aimed to suppress T-lymphocyte suppression and inflammatory responses and secondly to prevent fibrotic effects making it more likely to be effective in early stages of BOS. Early development of BOS, which mostly will not be diagnosed, and acute organ rejections are strongly patho-physiological associated. Prevention of the very early development of chronic rejection by L-CsA post LTX may be the ideal starting point for IMP application.
Sponsor: Pari Pharma GmbH

Current Primary Outcome: The primary objective is to compare cumulative BOS-free survival of patients recieving L-CsA or placebo. [ Time Frame: 2 years ]

BOS stage 1 and higher is considered as BOS for the primary endpoint.


Original Primary Outcome: Same as current

Current Secondary Outcome: Cumulative mean incidence of BOS 12, 18 and 24 months after first IMP administration [ Time Frame: 2 years ]

Further secondary objectives are to compare further efficacy and safety data from L-CsA versus placebo. Evaluation of IMP pharmacokinetic (PK) data in whole blood samples and bronchoalveolar lavage (BAL)are included in the outcome measure.

The main safety evaluation is the incidence of treatment-emergent AEs including clinically relevant laboratory parameters and vital signs



Original Secondary Outcome: Same as current

Information By: Pari Pharma GmbH

Dates:
Date Received: April 11, 2011
Date Started: December 2009
Date Completion:
Last Updated: April 13, 2015
Last Verified: April 2015