Lung and Heart-Lung Transplant Research Program

A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow Device plus Standard of Care versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Lung Transplantation (BOSTON-1 and BOSTON-2) 

These are Zambon S.p.A sponsored clinical trials to assess the effectiveness and safety of L-CsA plus standard of care (SoC) in the treatment of BOS in lung transplant recipients. Subjects will be randomized to one of two treatment arms: Group A: L-CsA treatment plus SoC therapy or Group B: SoC therapy alone. L-CsA will be administered via the PARI eFlow nebulizer twice a day for those subjects randomized to Group A.  

A Phase III, Multicenter, Open-Label, Extension Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Single or Double Lung TransplantationA Phase III, Multicenter, Open-Label, Extension Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered via the PARI Investigational eFlow® Device plus Standard of Care in the Treatment of Bronchiolitis Obliterans Syndrome in Patients post Single or Double Lung Transplantation (BOSTON-3)

The primary objective of this trial is to assess the long-term safety and efficacy of L-CsA plus Standard of Care (SoC) in the treatment of CLAD/BOS in single and double lung transplant recipients, who have completed either the BOSTON-1 or BOSTON-2 study

This study will evaluate the effectiveness of a coping skills and exercise intervention (CST-EX) in reducing distress and improving functional capacity among lung transplant recipients.  180 Duke lung transplant recipients will be randomized to 12 weeks of CST-ES or standard of care plus education.  Outcomes include measures of global distress, functional capacity, quality of life, and CLAD-free survival.  

This MPI UO1 award with University of Pennsylvania will define the long-term chronic lung allograft dysfunction phenotype of all the LTOG participants as well as determine the functional status and well-being of this large cohort of nearly 4000 lung transplant recipients.

The goals of this network are multifaceted and will use a collaborative approach among 10 North American lung transplant centers to improve the transplant referral process for CF patients, improve the coordination of care of post-transplant CF patients, as well as develop a biospecimen and data repository to improve long-term transplant outcomes.