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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: Completed Phase 3 study of Bronchiolitis Obliterans and Lung Transplant; Complications, sponsored by Zambon SpA.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
FEV1 is the Forced Expiratory Volume in One Second. The FEV1 data collected from the on-site COMPACTTM spirometer were to be considered primary, while data collected with the In2itiveTM home spirometer were to be used for supportive analyses.
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 |
What the finished NCT03656926 record still lists
NCT03656926 is an interventional study that assigns participants to a tested intervention. The registered 169 participants enrollment target is mid-sized for trials with a published cap, below the 390-participant average among 9 other Bronchiolitis Obliterans trials with a reported enrollment target (57% lower).
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 names 20 study sites across 12 states, led by 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03656926's enrollment target sits among peer trials
169 5th of 9 higher than 5 of 9 other Bronchiolitis Obliterans trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bronchiolitis Obliterans trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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