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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through study completion (52 weeks)
Awards & highlights

BOSTON-2 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.Check my eligibility
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.See study design
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.

BOSTON-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
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.

BOSTON-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through study completion (52 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through study completion (52 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change in FEV1 (mL) from baseline to Week 48)
Secondary outcome measures
Mean change in FEV1/FVC from baseline to Week 48
Time to Progression of BOS
Other outcome measures
Acute tolerability of L-CsA
Adverse Events

BOSTON-2 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
28 Previous Clinical Trials
5,758 Total Patients Enrolled
Paola Castellani, MDStudy DirectorZambon SpA, Chief Medical Officer
3 Previous Clinical Trials
513 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the most dangerous side effect of taking Liposomal Cyclosporine A?

"Given that this is a Phase 3 trial with evidence of efficacy and multiple rounds of data supporting safety, our team at Power rates the Liposomal Cyclosporine A as having a level 3 safety."

Answered by AI

In how many different places is this trial being run today?

"21 patients have already enrolled in this clinical trial at locations such as Inova Hospital, Duke University Medical Center, and the University of Maryland. Additionally, there are 21 other sites where enrollment is still open."

Answered by AI

Are there other similar investigations that have looked at Liposomal Cyclosporine A?

"As of now, 71 clinical trials investigating Liposomal Cyclosporine A are ongoing. 13 of those active studies are in their third phase. Many of the trials for this treatment occur in Assiut, but there are a total of 475 locations running these sorts of tests."

Answered by AI

How many different people are included in this clinical research project?

"In order to move forward with this clinical trial, we need 152 volunteers that fit the bill in terms of our inclusion criteria. Those who are interested can go to Inova Hospital in Falls Church, Virginia or Duke University Medical Center in Durham, North carolina to participate."

Answered by AI

What medical condition is Liposomal Cyclosporine A commonly used to treat?

"transplantation patients are often treated with Liposomal Cyclosporine A, which can also help ameliorate conditions like lupus nephritis, bulla, and excessive tearing."

Answered by AI

Are researchers still looking for volunteers for this trial?

"Yes, according to the information available on clinicaltrials.gov, this trial is still open and looking for candidates. The study was first posted on March 29th, 2019 and was last edited on March 15th, 2020. They are hoping to find 152 participants spread out across 21 different sites."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
What site did they apply to?
University of Pittsburgh Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

Last chance before possible lung transplant.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-2)
2019. "Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03656926.
All > Bronchiolitis Obliterans > Restasis
~37 spots leftby Apr 2025
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