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Immunosuppressant

L-CsA + Standard of Care for Bronchiolitis Obliterans Syndrome (BOSTON-3 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 three-drug maintenance regimen of immunosuppressive agents including tacrolimus or another CNI, a second agent such as but not limited to MMF or azathioprine, and a systemic corticosteroid such as prednisone.
Be older than 18 years old
Must not have
Receipt of an investigational drug, other than L-CsA, as part of a clinical trial within 4 weeks prior to Visit 1. This is defined as any treatment that is implemented under an Investigational New Drug (IND) or compassionate use.
Patients who experienced an AE related to study drug that led to permanent study drug discontinuation in BOSTON-1 or BOSTON-2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to end of study, approximately 2 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing how safe and effective L-CsA plus Standard of Care is in treating Breathing Obstruction Syndrome in people who have had either a single or double lung transplant.

Who is the study for?
This trial is for post lung transplant patients with Bronchiolitis Obliterans Syndrome (BOS) who are on a three-drug immunosuppressive regimen. They must have completed prior BOSTON trials without early termination or consent withdrawal, not be pregnant or breastfeeding, agree to use contraception, and have no new cancers except certain skin carcinomas.
What is being tested?
The study aims to evaluate the long-term safety and effectiveness of Liposomal Cyclosporine A (L-CsA) at two different doses added to Standard of Care in treating BOS after single or double lung transplants.
What are the potential side effects?
Potential side effects may include those commonly associated with cyclosporine such as kidney problems, high blood pressure, tremors, increased hair growth, gum swelling, and other immune-related issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am on a 3-drug regimen including tacrolimus (or similar), MMF/azathioprine, and a steroid.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not taken any experimental drugs, except L-CsA, in the last 4 weeks.
Select...
I stopped a study drug permanently due to side effects in BOSTON-1 or BOSTON-2.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to end of study, approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to end of study, approximately 2 years 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 from Baseline to Week 24
Secondary study objectives
Mean change in FEV1 from Baseline to End of Study
Mean change in FEV1 from Baseline to Week 48
Mean change in FEV1/FVC from Baseline to Week 24
+2 more
Other study objectives
Acute tolerability of L-CsA as measured by change in FEV1 at 1 hour and 4 hours after first inhalation of L-CsA
Acute tolerability of L-CsA as measured by number of patients with treatment-related adverse events
Adverse events
+1 more

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
Group I: L-CsA 5 mg plus Standard of CareExperimental Treatment1 Intervention
L-CsA 5 mg twice daily plus Standard of Care for up to 144 weeks for patients post Single Lung Transplant
Group II: L-CsA 10 mg plus Standard of CareExperimental Treatment1 Intervention
L-CsA 10 mg twice daily plus Standard of Care for up to 144 weeks for patients post Double Lung Transplant

Find a Location

Who is running the clinical trial?

Zambon SpALead Sponsor
30 Previous Clinical Trials
6,046 Total Patients Enrolled
4 Trials studying Bronchiolitis Obliterans
746 Patients Enrolled for Bronchiolitis Obliterans
Paola R Castellani, MDStudy DirectorZambon SpA, Chief Medical Officer

Media Library

Liposomal Cyclosporine A 10 mg (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT04039347 — Phase 3
Bronchiolitis Obliterans Research Study Groups: L-CsA 5 mg plus Standard of Care, L-CsA 10 mg plus Standard of Care
Bronchiolitis Obliterans Clinical Trial 2023: Liposomal Cyclosporine A 10 mg Highlights & Side Effects. Trial Name: NCT04039347 — Phase 3
Liposomal Cyclosporine A 10 mg (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04039347 — Phase 3
~46 spots leftby Dec 2025
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