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Immunosuppressant
Liposomal Cyclosporine A for Lung Transplant Rejection (BOSTON-2 Trial)
Phase 3
Waitlist Available
Research Sponsored by Zambon SpA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients should be on a maintenance regimen of immunosuppressive agents including tacrolimus, a second agent such as but not limited to MMF or azathioprine, and a systemic corticosteroid such as prednisone as third agent.
Patients should be on a maintenance regimen of immunosuppressive agents including tacrolimus, a second agent such as but not limited to MMF or azathioprine, and a systemic corticosteroid such as prednisone as third agent
Must not have
Patients with liver disease and abnormal liver function tests
Patients with confirmed other causes for loss of lung function, such as acute infection, acute rejection, restrictive allograft syndrome (RAS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through study completion (52 weeks)
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing whether adding a certain drug to the standard care for double lung transplant recipients helps treat Bronchiolitis obliterans syndrome.
Who is the study for?
Adults over 18 who had a double lung transplant at least a year ago and are diagnosed with Bronchiolitis Obliterans Syndrome (BOS). They must have specific lung function levels, be on stable immunosuppressive drugs, and not have certain infections or cancers. Pregnant women, those with severe liver or kidney issues, uncontrolled hypertension, or recent participation in other trials cannot join.
What is being tested?
The trial is testing if adding aerosolized liposomal cyclosporine A to the usual care for BOS after a double lung transplant is safe and works better than the usual care alone. Participants will either receive this new treatment or stick to their standard regimen.
What are the potential side effects?
Liposomal Cyclosporine A may cause breathing problems, high blood pressure, kidney issues, liver damage, increased risk of infection and possible allergic reactions among others. The exact side effects can vary from person to person.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am on a maintenance regimen that includes tacrolimus, another agent like MMF or azathioprine, and a corticosteroid.
Select...
I am on a maintenance regimen that includes tacrolimus, MMF or azathioprine, and a corticosteroid like prednisone.
Select...
I have BOS with specific FEV1 values showing lung function decline post-transplant.
Select...
My lung function is within a specific range or has decreased but shows signs of BOS progression.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have liver disease with abnormal liver function tests.
Select...
My lung function loss is due to a confirmed cause like infection or rejection.
Select...
I have Cystic Fibrosis with infections that don't respond to current treatments.
Select...
I am currently experiencing acute antibody-mediated rejection.
Select...
I have breathing tube narrowing that started after my BOS diagnosis and is still present.
Select...
I need extra oxygen or my oxygen levels are below 89% without it.
Select...
I have chronic kidney failure or need regular dialysis.
Select...
I have not had ECP treatment for BOS in the last month.
Select...
My high blood pressure is not under control.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through study completion (52 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through study completion (52 weeks)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean change in FEV1 (mL) from baseline to Week 48)
Secondary study objectives
Mean change in FEV1/FVC from baseline to Week 48
Time to Progression of BOS
Other study objectives
Acute tolerability of L-CsA
Adverse Events
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: L-CsA treatment plus SoCExperimental Treatment1 Intervention
Liposomal Cyclosporine A (L-CsA) 10 mg twice daily for 48 weeks, plus Standard of Care Therapy
Group II: Standard of CareActive Control1 Intervention
This is a maintenance regimen of immunosuppressive agents
Find a Location
Who is running the clinical trial?
Zambon SpALead Sponsor
30 Previous Clinical Trials
6,088 Total Patients Enrolled
Paola Castellani, MDStudy DirectorZambon SpA, Chief Medical Officer
3 Previous Clinical Trials
513 Total Patients Enrolled