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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to end of study, approximately 2 years

Awards & highlights

BOSTON-3 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.Check my eligibility

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.See study design

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.

BOSTON-3 Trial 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.

BOSTON-3 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to end of study, approximately 2 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean change in FEV1 from Baseline to Week 24

Secondary outcome measures

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 outcome measures

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

BOSTON-3 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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Zambon SpALead Sponsor

28 Previous Clinical Trials

5,716 Total Patients Enrolled

3 Trials studying Bronchiolitis Obliterans

446 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

Frequently Asked Questions

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

At how many different medical sites is this clinical trial taking place?

"Patients can be enrolled at UCLA in Los Angeles, California, Temple University Hospital in Philadelphia, Pennsylvania, Banner Health in Phoenix, Arizona or at one of the 20 other sites."

Answered by AI

How is Liposomal Cyclosporine A 5 mg typically used?

"Liposomal Cyclosporine A 5 mg is most often used for the treatment of transplantation. It can also be utilized to treat conditions that result in excessive tearing, lupus nephritis, and bulla."

Answered by AI

Could you please provide a comprehensive list of scientific papers that have been published on Liposomal Cyclosporine A 5 mg?

"There are currently 71 active trials related to Liposomal Cyclosporine A 5 mg. Of these, 13 have reached Phase 3. This medication is being tested in 475 different locations, with the majority of studies based in Assiut, Egypt."

Answered by AI

Has the FDA cleared Liposomal Cyclosporine A 5 mg for use?

"There is some data to suggest that Liposomal Cyclosporine A 5 mg is effective and it has undergone multiple rounds of safety testing, so our team at Power have given it a score of 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Extension Trial on Efficacy / Safety of L-CsA + SoC in Treating BOS in Post Single or Double Lung Transplant (BOSTON-3)

2020. "Extension Trial on Efficacy / Safety of L-CsA + SoC in Treating BOS in Post Single or Double Lung Transplant (BOSTON-3)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04039347.

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