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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
Must not have
Patients with confirmed other causes for loss of lung function, such as acute infection, acute rejection, restrictive allograft syndrome (CLAD - RAS phenotype, see Protocol Specific Definition)
Patients with liver disease and serum bilirubin > 3-fold upper limit of normal range or transaminases > 2.5 upper limit of normal range
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through study completion (52 weeks)
Awards & highlights
Pivotal Trial
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am on a stable 3-drug regimen for immunosuppression including tacrolimus.
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I do not have any other health conditions expected to be fatal within a year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My lung function loss is confirmed to be due to a specific cause other than cancer.
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My liver function tests are not more than 3 times the normal range.
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I have airway narrowing that started after my BOS diagnosis and is still present.
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I need extra oxygen or my oxygen levels are below 89% without it.
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I haven't taken any experimental drugs in the last 4 weeks.
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My high blood pressure is not under control.
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I have chronic kidney issues, with creatinine over 2.5 mg/dL or I'm on dialysis.

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

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

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

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

Media Library

Liposomal Cyclosporine A (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT03657342 — Phase 3
Lung Allograft Dysfunction Research Study Groups: Control treatment, L-CsA treatment plus SoC
Lung Allograft Dysfunction Clinical Trial 2023: Liposomal Cyclosporine A Highlights & Side Effects. Trial Name: NCT03657342 — Phase 3
Liposomal Cyclosporine A (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03657342 — Phase 3
~33 spots leftby Nov 2025
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