Lung and Heart-Lung Transplant Research Program

Belumosudil is an investigational drug that blocks a molecule in the body that reduces inflammation and scarring.  It is approved in the US, Canada, and Great Britain for the treatment of adult and pediatric patients 12 years and older with cGVHD after failure of at least 2 prior lines of systemic therapy, and in Australia for treatment of patients with cGVHD aged 12 years and older who have an inadequate response to corticosteroids. There are  shared mechanisms and clinical features of CLAD among lung transplant patients and GVHD. Therefore, the overall study hypothesis is that belumosudil will reduce the occurrence of CLAD when added to maintenance immunosuppression after the onset of Acute Rejection, Lymphocytic Bronchiolitis, Organizing Pneumonia,  or Acute Lung Injury. Participants are randomized (assigned, by chance) to one of the two groups, the Experimental Group (receives Belumosudil) and the Control Group (receives placebo) for one year. 

Principal Investigator: John Reynolds, MD
Status: Open to enrollment
IRB number: Pro00115958
ClinicalTrials.gov: NCT06476132
Study Coordinator: Stephanie Mabe (919) 684-8292

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: Erika Buckley (919) 660-7222

The purpose of this study is to examine the role of complement activation, and more broadly immune activation, in acute exacerbations and disease progression in idiopathic pulmonary fibrosis (IPF) and interstitial lung disease (ILD). We hope to determine how complement activation changes during acute exacerbation of IPF or ILD in hospitalized patients, in comparison to outpatients with IPF or ILD and healthy cohorts. In addition to complement proteins, we will evaluate changes in other blood biomarkers related to immune and epithelial cell dysfunction during an acute exacerbation of IPF or ILD.

Principal Investigator: Aparna Swaminathan, MD
Status: Open to enrollment
IRB number: Pro00111487
ClinicalTrials.gov: n/a
Study Coordinator: Havyn Kurtz (919-684-8913)

The purpose of this study is to collect data on all individuals with cystic fibrosis (CF) who are seen as patients in the Duke Combined CF Care Center. Information from each participant's clinic visits throughout the year is collected and entered into the CF Registry. These data are stored at the Cystic Fibrosis Foundation Registry website. Each year the CF Foundation generates an annual report of health trends for all participating care centers without identifying any individual. Data collected at Duke are used by our site in ongoing quality improvement initiatives.

Principal Investigator: Harvey Marshall, MD
Status: Open to enrollment
IRB number: Pro00116260
ClinicalTrials.gov: n/a
Study Coordinator: Erika Buckley (919-660-7222)
 

Despite the positive and life extending benefits of lung transplantation, challenges exist to further improve outcomes for lung transplant recipients. For example, lung donor utilization rates are lower and lung transplant candidate deaths on the waitlist are higher than for other commonly transplanted organs. Furthermore, despite current donor management strategies and recipient immunosuppression regimens, primary graft dysfunction (PGD), acute rejection (AR), and other forms of acute lung allograft dysfunction (ALAD) occur frequently. A major barrier to solving these problems has been the limited number of coordinated multicenter efforts to optimize the utilization of donor organs, define best practices with regards to lung transplant recipient care. To address these unmet needs, the National Heart, Lung, and Blood Institute (NHLBI) created the Lung Transplant Consortium (LTC) to serve as a research platform for rigorous observational and mechanistic studies in lung transplant. The LTC will implement the consortium-wide PROMISE-Lung Study protocol and enroll 2,600 participants expected to undergo lung transplantation and prospectively collect clinical data, biological specimens, and patient reported outcomes (PROs) to create a unique resource for future research that can directly address current challenges in the optimal management of lung transplant recipients and donors. 

Principal Investigator: Laurie Snyder, MD
Status: Open to enrollment
IRB number: Pro00115971
ClinicalTrials.gov: n/a
Study Coordinator: Erika Buckley (919-660-7222)

COPD has been increasingly recognized as a systemic disease affecting energy metabolism, immune system function, and aging related inflammation. While no current therapies significantly modify disease progression, pulmonary rehabilitation has been shown to be the most effective at reducing COPD hospitalizations. However, the underlying mechanisms by which pulmonary rehab mediates improvement are unknown. The purpose of this study is to collect biospecimens and clinical health data to investigate the effect of pulmonary rehab on cellular metabolism, immune system function, and biomarkers of aging related inflammation and examine if there is an association with clinical and pulmonary rehab related outcomes. 

Principal Investigator: Christopher Mosher, MD
Status: Open to enrollment
IRB number: Pro00107656
ClinicalTrials.gov: n/a
Study Coordinator: Havyn Kurtz (919) 684-8913
 

This double-blind, randomized, placebo-controlled, multinational, multicenter, parallel-group, Phase 3, 2-arm, study will investigate the efficacy and safety of belumosudil compared with placebo, both administered on top of azithromycin and standard-of-care regimen of immunosuppression in male or female participants at least 1 year after bilateral lung transplant, who are at least 18 years of age and who have evidence of progressive CLAD despite azithromycin therapy. A total of approximately 180 participants with CLAD Stage 1 or 2, assessed based on the International Society for Heart and Lung Transplantation (ISHLT) criteria, will be randomized 2:1 to receive either belumosudil (approximately 120 participants) or placebo (approximately 60 participants) during the 26-week double-blind treatment period. 

Principal Investigator: Jamie Todd, MD
Status: Open to enrollment
IRB number: Pro00113681
ClinicalTrials.gov: NCT06082037
Study Coordinator: Katelyn Arroyo (919-660-7224)