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NCT03657342 · ClinicalTrials.gov registry record · Phase 3
Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-1)
A Phase 3 study, sponsored by Zambon SpA.
- Completed
- Registry status
- Phase 3
- Development phase
- 62
- Enrollment target
NCT03657342: Completed Phase 3 study, sponsored by Zambon SpA.
NCT03657342 is a Phase 3 study that has completed, run by Zambon SpA. The registered enrollment target is 62 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03657342, a Phase 3 study, has completed, sponsored by Zambon SpA.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 62 participants
- Enrollment target
Study Summary
The objective of this trial is 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 single lung transplant recipients with chronic lung allograft dysfunction (CLAD)-bronchiolitis obliterans syndrome (BOS).
Primary Outcome
FEV1 is the Forced Expiratory Volume in One Second. For FEV1 were considered primary the data collected from the on site COMPACT study spirometer. Baseline is the mean of the best FEV1 obtained with the study spirometer at Screening Visit and the pre-randomization best FEV1 obtained at the Baseline Visit (V1).The primary efficacy analysis was carried out using a Linear Mixed Model (LMM) for repeated measures, using all observed available FEV1 measurements. In case of death or re-transplantation
Interventions
- DRUG Liposomal Cyclosporine A
- DRUG standard of care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2019-03-26 |
| Est. Completion | 2024-04-16 |
| Phase | Phase 3 |
What the finished NCT03657342 record still lists
NCT03657342 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Liposomal Cyclosporine A is the first listed.
NCT03657342 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03657342 about?
NCT03657342 is a clinical study titled "Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-1)". The objective of this trial is 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 single lung transplant recipients with chronic lung allograft dysfunction (CLAD)-bronchiolitis obliterans syndrome ...
What is the current status of trial NCT03657342?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 62 participants. The study started on 2019-03-26. Estimated completion is 2024-04-16.
What interventions are being tested in trial NCT03657342?
The interventions under investigation include: Liposomal Cyclosporine A (DRUG), standard of care (DRUG).
Who is sponsoring clinical trial NCT03657342?
This trial is sponsored by Zambon SpA, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03657342's enrollment target sits among peer trials
62 1802nd of 2000 higher than 198 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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