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NCT04039347 · ClinicalTrials.gov registry record · Phase 3
Extension Trial on Efficacy / Safety of L-CsA + SoC in Treating BOS in Post Single or Double Lung Transplant (BOSTON-3)
A Phase 3 study of Bronchiolitis Obliterans and Bronchiolitis Obliterans Syndrome, sponsored by Zambon SpA.
- Active
- Registry status
- Phase 3
- Development phase
- 262
- Enrollment target
- 20
- Study locations
NCT04039347: Active Phase 3 study of Bronchiolitis Obliterans and Bronchiolitis Obliterans Syndrome, sponsored by Zambon SpA.
NCT04039347 is a Phase 3 study of Bronchiolitis Obliterans and Bronchiolitis Obliterans Syndrome that is active but no longer recruiting, run by Zambon SpA. The registered enrollment target is 262 participants, below the 380-participant average among 9 other Bronchiolitis Obliterans trials with a reported enrollment target (31% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04039347, a Phase 3 study of Bronchiolitis Obliterans and Bronchiolitis Obliterans Syndrome, is active but no longer recruiting, sponsored by Zambon SpA.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 262 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of the trial is to assess the long-term safety and efficacy of L-CsA plus Standard of Care (SoC) in the treatment of BOS in single (SLT) and double lung transplant (DLT) recipients.
Primary Outcome
FEV1 is the Forced Expiratory Volume in One Second
Conditions Studied
Interventions
- DRUG Liposomal Cyclosporine A 5 mg
- DRUG Liposomal Cyclosporine A 10 mg
Study Locations (20)
Texas
- Baylor University Medical Center - Dallas
- University of Texas Southwestern Medical Center - Dallas
- Baylor College of Medicine - Houston
- Houston Methodist Hospital - Houston
California
- David Geffen School of Medicine at UCLA - Los Angeles
- UCSF - San Francisco
- UCSF Center for Advanced Lung Disease - Stanford
Maryland
- University of Maryland - Baltimore
- Johns Hopkins University Hospital - Baltimore
Ohio
- Cleveland Clinic - Cleveland
- OSU Wexner Medical Center - Columbus
Pennsylvania
- Temple University Hospital - Philadelphia
- University of Pittsburgh Medical Center - Pittsburgh
Arizona
- Banner - University Medical Center - Phoenix
Florida
- University of Florida Dept of Pulmonary Medicine - Gainesville
Indiana
- Indiana University - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 262 participants |
| Start Date | 2020-03-12 |
| Est. Completion | 2025-12 |
| Phase | Phase 3 |
What the registry record for NCT04039347 still lists
NCT04039347 is an interventional study that assigns participants to a tested intervention. The registered 262 participants enrollment target is mid-sized for trials with a published cap, below the 380-participant average among 9 other Bronchiolitis Obliterans trials with a reported enrollment target (31% lower).
The record links to 3 conditions, with Bronchiolitis Obliterans appearing as the primary indexed condition, and to 2 interventions - of which Liposomal Cyclosporine A 5 mg is the first listed.
NCT04039347 names 20 study sites across 12 states, led by Texas, California, Maryland.
Frequently Asked Questions
What is clinical trial NCT04039347 about?
NCT04039347 is a clinical study titled "Extension Trial on Efficacy / Safety of L-CsA + SoC in Treating BOS in Post Single or Double Lung Transplant (BOSTON-3)". The objective of the trial is to assess the long-term safety and efficacy of L-CsA plus Standard of Care (SoC) in the treatment of BOS in single (SLT) and double lung transplant (DLT) recipients.
What is the current status of trial NCT04039347?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 262 participants. The study started on 2020-03-12. Estimated completion is 2025-12.
What conditions does trial NCT04039347 study?
This clinical trial studies the following conditions: Bronchiolitis Obliterans, Bronchiolitis Obliterans Syndrome, Obliterative Bronchiolitis.
What interventions are being tested in trial NCT04039347?
The interventions under investigation include: Liposomal Cyclosporine A 5 mg (DRUG), Liposomal Cyclosporine A 10 mg (DRUG).
Who is sponsoring clinical trial NCT04039347?
This trial is sponsored by Zambon SpA, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04039347 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
Similar trials for Bronchiolitis Obliterans
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 NCT04039347's enrollment target sits among peer trials
262 3rd of 9 higher than 7 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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Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Double Lung Transplant (BOSTON-2)
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COMPLETED · Phase 1
-
Immune Mediated Disorders After Allogeneic Hematopoietic Cell Transplantation
COMPLETED
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