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COMPLETED Phase 3

Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Double Lung Transplant (BOSTON-2)

NCT03656926 · View on ClinicalTrials.gov ↗

Study Summary

The objective of this trial was to assess the efficacy and safety of aerosolized liposomal cyclosporine A (L-CsA) as add-on therapy to standard of care (SoC) as compared to SoC alone in double lung transplant (DLT) recipients with chronic lung allograft dysfunction (CLAD)-bronchiolitis obliterans syndrome (BOS).

Interventions

  • DRUG Standard of Care
  • DRUG Liposomal Cyclosporine A

Study Locations (20)

California

  • UCLA Medical Center — Los Angeles
  • Stanford University Hospital — Palo Alto
  • UC San Francisco — San Francisco

Florida

  • University of Florida Medical Center — Gainesville
  • Mayo Clinic Jacksonville — Jacksonville
  • University of South Florida — Tampa

Maryland

  • University of Maryland — Baltimore
  • Johns Hopkins University Hospital — Baltimore

Ohio

  • Cleveland Clinic — Cleveland
  • Ohio State University Medical Center — Columbus

Pennsylvania

  • Temple University Hospital — Philadelphia
  • University of Pittsburgh Medical Center — Pittsburgh

Texas

  • Baylor University Medical Center — Dallas
  • Baylor College of Medicine — Houston

Arizona

  • Banner Health — Phoenix

Indiana

  • Indiana University — Indianapolis

Trial Details

FieldValue
Enrollment Target 169 participants
Start Date 2019-03-26
Est. Completion 2024-03-12
Phase Phase 3

Sponsor

Zambon SpA

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03656926

The ClinicalTrials.gov registry entry for NCT03656926 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 169 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Zambon SpA, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 6 conditions, with Bronchiolitis Obliterans appearing as the primary indexed condition, and to 2 interventions — of which Standard of Care is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03656926 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03656926 about?

NCT03656926 is a clinical study titled "Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Double Lung Transplant (BOSTON-2)". The objective of this trial was to assess the efficacy and safety of aerosolized liposomal cyclosporine A (L-CsA) as add-on therapy to standard of care (SoC) as compared to SoC alone in double lung transplant (DLT) recipients with chronic lung allograft dysfunction (CLAD)-bronchiolitis obliterans sy...

What is the current status of trial NCT03656926?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 169 participants. The study started on 2019-03-26. Estimated completion is 2024-03-12.

What conditions does trial NCT03656926 study?

This clinical trial studies the following conditions: Bronchiolitis Obliterans, Lung Transplant; Complications, Lung Transplant Rejection, Chronic Lung Allograft Dysfunction, Lung Transplant Failure and Rejection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03656926?

The interventions under investigation include: Standard of Care (DRUG), Liposomal Cyclosporine A (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03656926?

This trial is sponsored by Zambon SpA, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03656926 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial