Clinical Trials

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, FL

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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

Location:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Open for enrollment	View complete study & contact information

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Site IRB:
- Jacksonville, Florida: 19-004402
NCT ID:
NCT03657342
Sponsor Protocol Number:
BT - L-CsA - 301 - SLT

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, FL

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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

Location:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Open for enrollment	View complete study & contact information

Print study details

Site IRB:
- Jacksonville, Florida: 20-001211
NCT ID:
NCT04039347
Sponsor Protocol Number:
BT–L-CsA–303–FU

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

Rochester, MN

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

Location:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information

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Site IRB:
- Rochester, Minnesota: 19-008807
NCT ID:
NCT04245228
Sponsor Protocol Number:
19-008807

A Study to Verify the Application of Lung Ultrasound Artefact Analysis for Exclusion of Acute Rejection in Asymptomatic Lung Transplant Recipients

Jacksonville, FL

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A Study to Verify the Application of Lung Ultrasound Artefact Analysis for Exclusion of Acute Rejection in Asymptomatic Lung Transplant Recipients

Location:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

A normal lung ultrasound artifact pattern in an aymptomatic lung transplant recipient with normal chest radiograph and spirometry can safely exclude significant acute cellular rejection.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Open for enrollment	View complete study & contact information

Print study details

Site IRB:
- Jacksonville, Florida: 20-002489
NCT ID:
NCT04582279

Pre-transplant Health Coaching to Improve Patient-Reported Outcomes in Lung Transplant Candidates

Rochester, MN, Jacksonville, FL

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Pre-transplant Health Coaching to Improve Patient-Reported Outcomes in Lung Transplant Candidates

Location:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The purpose of this study is to examine the effectiveness of a phone call ≤ 30 minute per session, 12-session, weekly individual health-coaching intervention, completed over 12-16 weeks in adults on the lung transplant waiting list versus usual transplant care.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information
Jacksonville, Fla.	Open for enrollment	View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 21-002675
- Jacksonville, Florida: 21-002675
NCT ID:
NCT05426200

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, FL

See Details

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)

Location:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase:
3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Open for enrollment	View complete study & contact information

Print study details

Site IRB:
- Jacksonville, Florida: 19-004406
NCT ID:
NCT03657342
Sponsor Protocol Number:
BT - L-CsA - 301 - SLT

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

Jacksonville, FL

See Details

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

Location:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Open for enrollment	View complete study & contact information

Print study details

Site IRB:
- Jacksonville, Florida: 20-012778

Heart Failure and Cardiothoracic Transplant Biorepository

Rochester, MN

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Heart Failure and Cardiothoracic Transplant Biorepository

Location:
Observational
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

This study is being done to develop a serum and tissue bank for future research of patients with heart failure, mechanical circulatory support and/or cardiothoracic transplants. This blood/tissue will be used for three principle purposes: (1) laboratory tests which will be available in the future but that are not currently available and which may be of benefit to the patient, (2) review of previous patient laboratory results made necessary by development of a new disease process by the patient, and (3) future unspecified research purposes.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 162-95
Sponsor Protocol Number:
162-95

Caregiver Registry

Rochester, MN

See Details

Caregiver Registry

Location:
Observational
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

Currently transplant caregivers are viewed as healthy volunteers caring for patients following heart or lung transplant. However research has revealed that thoracic transplant caregivers have increased mood disorders, distress, and high caregiver burden, especially while caring for patients on the organ transplant waiting list. By monitoring caregiver traits and behaviors we will be better able to provide care and services for CG to improve both CG and patient outcomes.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 19-012536

A Study to Analyze Lung Transplant Recipients’ Perspective on Antifungal Prophylaxis

Rochester, MN, Jacksonville, FL

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A Study to Analyze Lung Transplant Recipients’ Perspective on Antifungal Prophylaxis

Location:
Observational
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The purpose of this study is to explore adherence, barriers, side effects, and preference for pharmacologic antifungal prophylaxis following lung transplant.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information
Jacksonville, Fla.	Closed for enrollment	View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 19-006102
- Jacksonville, Florida: 19-006102
Sponsor Protocol Number:
19-006102

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Search Results 1-10 of 15 for

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

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

A Study to Verify the Application of Lung Ultrasound Artefact Analysis for Exclusion of Acute Rejection in Asymptomatic Lung Transplant Recipients

Pre-transplant Health Coaching to Improve Patient-Reported Outcomes in Lung Transplant Candidates

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

Heart Failure and Cardiothoracic Transplant Biorepository

Caregiver Registry

A Study to Analyze Lung Transplant Recipients’ Perspective on Antifungal Prophylaxis

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