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NCT03656926 · ClinicalTrials.gov registry record · Phase 3
Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Double Lung Transplant (BOSTON-2)
A Phase 3 study of Bronchiolitis Obliterans and Lung Transplant; Complications, sponsored by Zambon SpA.
- Completed
- Registry status
- Phase 3
- Development phase
- 169
- Enrollment target
- 20
- Study locations
NCT03656926 is a Phase 3 study of Bronchiolitis Obliterans and Lung Transplant; Complications that has completed, run by Zambon SpA. The registered enrollment target is 169 participants, below the 390-participant average among 9 other Bronchiolitis Obliterans trials with a reported enrollment target (57% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT03656926, a Phase 3 study of Bronchiolitis Obliterans and Lung Transplant; Complications, has completed, sponsored by Zambon SpA.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 169 participants
- Enrollment target
- 20
- Study locations
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).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 169 participants |
| Start Date | 2019-03-26 |
| Est. Completion | 2024-03-12 |
| Phase | Phase 3 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 169 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 390-participant average among 9 other Bronchiolitis Obliterans trials with a reported enrollment target (57% lower). The listed sponsor is Zambon SpA, which has 5 total studies on file at ClinicalTrials.gov.
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.
NCT03656926 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Florida, Maryland.
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.
What interventions are being tested in trial NCT03656926?
The interventions under investigation include: Standard of Care (DRUG), Liposomal Cyclosporine A (DRUG).
Who is sponsoring clinical trial NCT03656926?
This trial is sponsored by Zambon SpA, which has 5 total clinical trials registered on ClinicalTrials.gov.
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.
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