Trial · NCT03657342
Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-1)
NCT03657342, Phase 3, Completed, Zambon SpA; results first posted 2025-10-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-1). Trials, record NCT03657342. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03657342
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-1)
- NCT number
- NCT03657342
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 62 participants, actual
- Lead sponsor
- Zambon SpA
- Conditions
- Bronchiolitis Obliterans, Chronic Rejection of Lung Transplant, Lung Transplant Rejection, Lung Transplant; Complications, Lung Transplant Failure and Rejection, Chronic Lung Allograft Dysfunction
- Interventions
- Liposomal Cyclosporine A, standard of care
- First posted
- 2018-09-05
- Last updated
- 2025-10-27
- Other registries' IDs
- eudract:2018-003204-39
- Results first posted
- 2025-10-27
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in FEV1 (L) From Baseline to Week 48 | Week 48 (V9) | 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 events, FEV1 was imputed as zero at each nominal day post event. PS: Estimates are from a LMM on the response variable with factors for time splines, treatment, the interactions of time splines by treatment, baseline FEV1, the interactions of time splines with baseline FEV1, region, underlying indication for lung transplant (COPD vs all others), use of azithromycin at randomization, and time as random effect. |
| Secondary | Mean Change in FEV1/FVC From Baseline to Week 48 | Week 48 | Forced Expiratory Volume in One Second on Forced Vital Capacity. It was analysed in the FAS using a LMM for repeated measurements and COMPACT data, with baseline FEV1/FVC among covariates. In case of death or re- transplantation events, FEV1/FVC was imputed as zero at each nominal day post event. FEV1/FVC is a calculated ratio used to diagnose obstructive and restrictive lung disease. It represents the proportion of a patient's vital capacity that he/she is able to expire in the first second of forced expiration to the full forced vital capacity. |
| Secondary | Time to Progression of Bronchiolitis Obliterans Syndrome (BOS) | From date of randomization until the date of first documented progression of BOS, or date of retransplantation, or date of death from respiratory failure, whichever came first, assessed up to 48 weeks. | The progression of BOS is defined as the earliest of the following: * Absolute decrease from baseline in FEV1 by at least 10% or 200 mL and a decrease in FEV1/FVC by at least 5% (if a patient had an event that met this criterion for progression of BOS, progression of BOS must have been confirmed by measurements that were taken with COMPACT spirometer at least 2 weeks apart) OR * Worsening of BOS grade, OR * Re-transplantation, OR * Death from respiratory failure. Rules for censoring progression of BOS are set. More than one type of event might correspond to the event of BOS progression (even those occurring on the same date). In case progression of BOS was defined by more than one criterion on different dates, the earliest event date was considered, i.e., the date closer to randomization was used as the progression date. |
| Other | Number of Patients With Adverse Events (AE) | Baseline through study completion (week 48) | An AE is an untoward medical occurrence after exposure to a medicine, which is not necessarily caused by that medicine. |
| Other | Acute Tolerability of L-CsA: Change From Pre-dose to 1 hr and 4h Post-dose | Baseline through study completion Week 48 | Acute tolerability of IMP (L-CsA) during initial dosing was determined by measuring spirometry 1 hour and 4 hours after treatment. The FEV1 was measured prior to dosing with L-CsA. A decline of ≥20% associated with symptoms could have warranted IMP discontinuation. Parameters reflecting acute tolerability of IMP were: spirometry, cough, or dyspnea. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change in FEV1 (L) From Baseline to Week 48 | Week 48 (V9) | FAS: The FAS is defined as all randomized patients. Patients were analyzed according to the treatment group to which they were randomized. All primary and secondary endpoints were performed using the FAS, unless otherwise specified. n=25 is the number of patients with data available, not the number of patients in the analysis set (N). | liters | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change in FEV1/FVC From Baseline to Week 48 | Week 48 | FAS: The FAS is defined as all randomized patients. Patients were analyzed according to the treatment group to which they were randomized. All primary and secondary endpoints were performed using the FAS, unless otherwise specified. n=25 is the number of patients with data available, not the number of patients in the analysis set (N). | ratio | LEAST_SQUARES_MEAN |
| SECONDARY | Time to Progression of Bronchiolitis Obliterans Syndrome (BOS) | From date of randomization until the date of first documented progression of BOS, or date of retransplantation, or date of death from respiratory failure, whichever came first, assessed up to 48 weeks. | FAS: The FAS is defined as all randomized patients. Patients were analyzed according to the treatment group to which they were randomized. All primary and secondary endpoints were performed using the FAS, unless otherwise specified. | Weeks | MEDIAN |
| OTHER_PRE_SPECIFIED | Number of Patients With Adverse Events (AE) | Baseline through study completion (week 48) | SAF: The SAF was defined as all randomized patients receiving SoC and/or at least one dose of L-CsA, independently of the treatment allocation at randomization. All safety and tolerability data were summarized and analyzed using the SAF. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Acute Tolerability of L-CsA: Change From Pre-dose to 1 hr and 4h Post-dose | Baseline through study completion Week 48 | SAF: The SAF was defined as all randomized patients receiving SoC and/or at least one dose of L-CsA, independently of the treatment allocation at randomization. All safety and tolerability data were summarized and analyzed using the SAF. | Liters | MEAN |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change in FEV1 (L) From Baseline to Week 48 | L-CsA treatment plus SoC (FAS) | -0.186 | Standard Error 0.3093 | liters | |
| Mean Change in FEV1 (L) From Baseline to Week 48 | SoC alone (FAS) | -0.090 | Standard Error 0.2879 | liters | |
| Mean Change in FEV1/FVC From Baseline to Week 48 | L-CsA treatment plus SoC (SAF) | 0.093 | Standard Error 0.2353 | ratio | |
| Mean Change in FEV1/FVC From Baseline to Week 48 | SoC alone (SAF) | 0.157 | Standard Error 0.2433 | ratio | |
| Time to Progression of Bronchiolitis Obliterans Syndrome (BOS) | L-CsA treatment plus SoC (FAS) | NA | 95% Confidence Interval NA to NA | Weeks | |
| Time to Progression of Bronchiolitis Obliterans Syndrome (BOS) | SoC alone (FAS) | NA | 95% Confidence Interval NA to NA | Weeks | |
| Number of Patients With Adverse Events (AE) | L-CsA treatment plus SoC (SAF) | No of patients with any AE | 32 | Participants | |
| Number of Patients With Adverse Events (AE) | SoC alone (SAF) | No of patients with any AE | 25 | Participants | |
| Number of Patients With Adverse Events (AE) | L-CsA treatment plus SoC (SAF) | No. of patients with any TEAE leading to discontinuation of study treatment | 8 | Participants | |
| Number of Patients With Adverse Events (AE) | SoC alone (SAF) | No. of patients with any TEAE leading to discontinuation of study treatment | 2 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | L-CsA treatment plus SoC | 32 | |
| Overall Study | STARTED | SoC alone | 30 | |
| Overall Study | FAS | L-CsA treatment plus SoC | 32 | |
| Overall Study | FAS | SoC alone | 30 | |
| Overall Study | SAF | L-CsA treatment plus SoC | 32 | |
| Overall Study | SAF | SoC alone | 30 | |
| Overall Study | PPS | L-CsA treatment plus SoC | 21 | |
| Overall Study | PPS | SoC alone | 19 | |
| Overall Study | COMPLETED | L-CsA treatment plus SoC | 20 | |
| Overall Study | COMPLETED | SoC alone | 23 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events118
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COVID-19 | Infections and infestations | L-CsA treatment plus SoC (SAF) | 7 | 32 | 9 |
| other | COVID-19 | Infections and infestations | SoC alone (SAF) | 5 | 30 | 5 |
| other | Bronchitis | Infections and infestations | L-CsA treatment plus SoC (SAF) | 3 | 32 | 3 |
| other | Bronchitis | Infections and infestations | SoC alone (SAF) | 1 | 30 | 1 |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | L-CsA treatment plus SoC (SAF) | 4 | 32 | 7 |
| other | Dyspnoea | Respiratory, thoracic and mediastinal disorders | SoC alone (SAF) | 4 | 30 | 4 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | L-CsA treatment plus SoC (SAF) | 5 | 32 | 5 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | SoC alone (SAF) | 2 | 30 | 2 |
| other | Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | L-CsA treatment plus SoC (SAF) | 4 | 32 | 4 |
| other | Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | SoC alone (SAF) | 0 | 30 | 0 |
1 to 10 of 118Source ClinicalTrials.gov
See all 118 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | L-CsA treatment plus SoC (SAF) | 6 | 32 |
| Total, all-cause mortality | SoC alone (SAF) | 3 | 30 |
| Total, other adverse events | L-CsA treatment plus SoC (SAF) | 28 | 32 |
| Total, other adverse events | SoC alone (SAF) | 17 | 30 |
| Total, serious adverse events | L-CsA treatment plus SoC (SAF) | 20 | 32 |
| Total, serious adverse events | SoC alone (SAF) | 14 | 30 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| L-CsA treatment plus SoC (SAF) vs SoC alone (SAF): deaths from any cause | Trial comparisons |
| L-CsA treatment plus SoC (SAF) vs SoC alone (SAF): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03657342
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