Lung and Heart-Lung Transplant Research Program

In addition to our outstanding clinical program, Duke is also a world leader in lung transplant research.

Our team has led numerous multicenter and single studies that have contributed to advancing patient care, and conducted basic and translational research that has enhanced our understanding of transplant immunology.

Researchers in the Duke Lung and Heart-Lung Transplant Program have authored or co-authored over 100 peer-reviewed research publications and edited several books or special journal issues devoted to transplantation.

Current Research Studies

Current research in the Lung and Heart-Lung Transplant Program examines the causes of acute and chronic organ rejection as well as ways to accurately predict which patients will suffer from acute or chronic rejection.

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.  

Principal Investigator: John Reynolds, MD
Status: Open to enrollment
IRB number Pro00101300 and Pro00101336
ClinicalTrials.gov NCT03657342 and NCT03656926
Study Coordinator: Katelyn Arroyo (919.684.8913)

 

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

Principal Investigator: John Reynolds, MD
Status: Open to enrollment
IRB number Pro00104578
ClinicalTrials.gov NCT04039347
Study Coordinator: Katelyn Arroyo (919.684.8913)

 

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.  

Principal Investigator: James Blumenthal, MD and Scott Palmer, MD
Status: Open to enrollment
IRB number Pro00100300
ClinicalTrials.gov NCT04093869
Study Coordinator: Katie Welsh (919.668.3555)

 

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.

Principal Investigator: Scott Palmer, MD
Status: Open to enrollment
IRB number Pro00105070
ClinicalTrials.gov NCT04787822
Study Coordinator: Alexis Paterson (919.660.6254)

 

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.  

Principal Investigator: Laurie Snyder, MD
Status: Open to enrollment
IRB number Pro00107143
ClinicalTrials.gov n/a
Study Coordinator: Alexis Paterson (919.660.6254)

Historically Relevant Research Studies

Researchers in the Lung and Heart-Lung Transplant Program at Duke continually search for new and innovative ways to improve lung transplant outcomes. Their research has helped to improve the field of lung transplantation and has resulted in improved outcomes for patients.