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Immunosuppressant
Liposomal Cyclosporine A for Bronchiolitis Obliterans Syndrome (BOSTON-1 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. The regimen must be stable within 4 weeks prior to randomization with respect to the therapeutic agents
Patients have no concomitant diagnoses that are considered fatal within one year (12 months) of Screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through study completion (52 weeks)
Awards & highlights
BOSTON-1 Trial Summary
This trial is testing whether adding a certain medication to the usual care for people with BOS may help improve symptoms.
Who is the study for?
This trial is for adults over 18 who had a single lung transplant at least a year ago and are diagnosed with Bronchiolitis Obliterans Syndrome (BOS). They must have stable immunosuppressive therapy, understand the study, consent to data retrieval, not be pregnant or breastfeeding, use contraception if applicable, and not have any life-threatening conditions expected within a year.Check my eligibility
What is being tested?
The trial tests aerosolized liposomal cyclosporine A added to standard care versus standard care alone in treating BOS after lung transplantation. The goal is to see if this new treatment improves lung function and patient outcomes compared to usual treatments.See study design
What are the potential side effects?
Potential side effects of liposomal cyclosporine A may include respiratory issues due to inhalation therapy, immune system suppression leading to increased infection risk, possible kidney problems as seen with other forms of cyclosporine A, and general drug sensitivity reactions.
BOSTON-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am on a stable 3-drug regimen for immunosuppression including tacrolimus.
Select...
I do not have any other health conditions expected to be fatal within a year.
BOSTON-1 Trial 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
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-1 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: L-CsA treatment plus SoCExperimental Treatment1 Intervention
Liposomal Cyclosporine A 5 mg twice daily for 48 weeks + Standard of Care Therapy
Group II: Control treatmentActive Control1 Intervention
In this arm only the standard of care is administered. Standard of care is a maintenance regimen of immunosuppressive agents.
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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
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lung function loss is confirmed to be due to a specific cause other than cancer.My liver function tests are not more than 3 times the normal range.I don't have any active infections, or if I do, they are stable and not a concern.I have airway narrowing that started after my BOS diagnosis and is still present.I haven't had any cancer except for treated skin cancer in the last 2 years.I am over 18 and had a lung transplant more than a year ago.I was diagnosed with CLAD-BOS over a year after my lung transplant and have shown a decline in lung function.I have acute antibody-mediated rejection and stable health, with detectable donor-specific antibodies.I need extra oxygen or my oxygen levels are below 89% without it.I haven't taken any experimental drugs in the last 4 weeks.I am on a stable 3-drug regimen for immunosuppression including tacrolimus.My high blood pressure is not under control.I do not have any other health conditions expected to be fatal within a year.I have been on a breathing machine in the last 12 weeks.I have BOS with specific lung function measurements showing decline or stability.You are allergic to L-CsA or cyclosporine A.My lung condition has been confirmed as BOS after ruling out other causes.You are currently taking part in another research study.I have chronic kidney issues, with creatinine over 2.5 mg/dL or I'm on dialysis.I have not had ECP treatment for BOS in the last month.
Research Study Groups:
This trial has the following groups:- Group 1: Control treatment
- Group 2: L-CsA treatment plus SoC
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does Liposomal Cyclosporine A have any harmful side effects?
"Liposomal Cyclosporine A is in Phase 3 of clinical trials, which suggests that while there is some data supporting its efficacy, multiple rounds of testing have shown it to be safe."
Answered by AI
What does the medical literature say about Liposomal Cyclosporine A?
"Right now, 71 different clinical trials are studying the effects of Liposomal Cyclosporine A. Of these, 13 are in Phase 3. Not only is Assiut, Assiut home to several research centres for this medication, but there are also 475 other locations around the world conducting similar studies."
Answered by AI
What are the main conditions that Liposomal Cyclosporine A is used to treat?
"In addition to transplantation, Liposomal Cyclosporine A is an effective treatment for other conditions like bulla, lupus nephritis, and excessive tearing."
Answered by AI
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