Lung Transplant Program

Below are current clinical trials.

Filter this list of studies by location, status and more.

1. BT – L-CsA – 301 – SLT: A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Efficacy 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 Chronic Lung Allograft Syndrome / Bronchiolitis Obliterans Syndrome in Patients post Single Lung Transplantation

   Jacksonville, Fla.

   The purpose of this study is to analyze L-CsA for the treatment of bronchiolitis obliterans syndrome in adults diagnosed with Bronchiolitis Obliterans Syndrome (BOS) following single-lung transplant. Patients will receive either L-CsA (5 mg) via the PARI Investigational eFlow® Device twice daily plus Standard of Care (SoC) treatment, or SoC alone, for a period of 48 weeks. All patients will be eligible to continue in an open-label extension trial of L-CsA following completion of BOSTON-1.

2. An Open Label Follow-Up Study to Evaluate the Long Term Safety and Efficacy of L-CSA in Patients with a Diagnosis of CLAD-BOS after they have completed participation to BOSTON-1 and BOSTON-2 studies

   Jacksonville, Fla.

   The purpose of this study is to assess the long-term effectiveness and safety of L-CsA plus Standard of Care (SoC) in the treatment of BOS in single (SLT) and double lung transplant (DLT) recipients.

   Enrollment will be limited to patients who have completed 48 weeks participation in either the BT-L-CsA-301-SLT (BOSTON-1) or BT-L-CsA-302-DLT (BOSTON-2) trial. All patients in this clinical trial will receive L-CsA in addition to Standard of Care, regardless of randomization arm in prior trials.

3. A Study to Evaluate Wellness Coaching for Caregivers of Thoracic Transplant Candidates

   Rochester, Minn.

   The purpose of this study is to examine the effects of a health coaching intervention on the stress and burden of caregivers of patients awaiting heart or lung transplant.

   Hypotheses:  Caregivers will have traits and behaviors pre-transplant that will predict caregiver readiness, quality of life, and transplant recipient outcomes. Specifically, thoracic pre-transplant caregivers report stress, symptoms of anxiety or depression, and perceive high caregiver burden. These factors may be amenable to pre-transplant intervention to improve overall patient and caregiver outcomes.

   Aims, purpose, or objectives:  We will conduct a pilot trial to test whether caregivers of heart and lung transplant candidates who receive wellness coaching will experience improvement in caregiver-related distress. We will also explore the relationship between caregiving and factors such as uncertainty, resilience, stress level, and affect.

4. A Study to Evaluate Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility

   Jacksonville, Fla.

   The purpose of this study is to evaluate the safety and effectiveness of the Centralized Lung Evaluation System (CLES) in enabling evaluation of potential donor lungs not otherwise used for transplant into subjects with end stage, survival-limiting lung disease in need of lung transplantation. This will be accomplished by evaluating subject survival at the later of 6 months or hospital discharge post-transplant.

5. A Study to Explore Ghrelin Levels with Primary Graft Dysfunction in Lung Transplant Recipients

   Jacksonville, Fla.

   The purpose of this study is to investigate ghrelin, a peptide that mechanistically carries the promise of therapeutics benefit for diverse aspects of morbidity associated with lung transplantation.

6. Donor-Specific Cell Free DNA Monitoring of Thoracic Allografts

   Rochester, Minn., Jacksonville, Fla.

   The purpose of this study is to determine if DNA originating from the transplanted heart or lung can be detected in the blood and used to monitor for rejection.

7. A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Efficacy 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 Chronic Lung Allograft Syndrome / Bronchiolitis Obliterans Syndrome in Patients post Double Lung Transplantation (BOSTON-2)

   Jacksonville, Fla.

   The purpose of this study is to evaluate L-CsA for the treatment of bronchiolitis obliterans syndrome in adults diagnosed with Bronchiolitis Obliterans Syndrome (BOS) following double-lung transplant. Patients will receive either L-CsA (5 mg) via the PARI Investigational eFlow® Device twice daily plus Standard of Care (SoC) treatment, or SoC alone, for a period of 48 weeks. All patients will be eligible to continue in an open-label extension trial of L-CsA following completion of BOSTON-2.

8. A Study to Evaluate the Role of Mitochondrial DNA in Encoding Histocompatibility Antigens in Humans and Rejection in Heart and Lung Transplant

   Jacksonville, Fla.

   The purpose of this retrospective and prospective study is to evaluate tissue bank from donors and recipients who underwent heart and lung transplant in order to study the Role of Mitochondrial DNA in Encoding Histocompatibility Antigens in humans and rejection.

    

    

9. A Study to Evaluate the Effect of Inspiratory Muscle Training on Physiological Function and Clinical Outcomes Following Lung Transplant

   Jacksonville, Fla.

   The purpose of this study is to to mechanistically investigate the effect of specific inspiratory muscle training on respiratory function, exercise capacity, health-related quality-of-life, and short-term clinical outcomes in patients after lung transplant.

10. A Study to Evaluate the Safety of the SARS-CoV-2 Vaccination in Patients Waitlisted for Solid Organ Transplantation

    Jacksonville, Fla.

    The purpose of this study is to determine the safety of the SARS-CoV-2 vaccination in patients listed for solid organ transplantation, including heart, lung, liver, kidney, and pancreas.