Trial · NCT04107675
A Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis After Hematopoietic Transplant (BOSTON-4)
NCT04107675, Phase 2, Terminated, Zambon SpA; results first posted 2023-10-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis After Hematopoietic Transplant (BOSTON-4). Trials, record NCT04107675. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04107675
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis After Hematopoietic Transplant (BOSTON-4)
- NCT number
- NCT04107675
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- Zambon SpA
- Conditions
- Bronchiolitis Obliterans Syndrome (BOS), GVHD, Chronic, Stem Cell Transplant Complications
- Interventions
- Liposomal Cyclosporine A, Liposomal Placebo
- First posted
- 2019-09-27
- Last updated
- 2023-10-03
- Other registries' IDs
- eudract:2019-000718-13
- Results first posted
- 2023-10-03
- Limitations and caveats
From the beginning of the trial, only 6 patients were enrolled. Due to the low number of patients recruited so far and the slow enrolment pace of patients, on 18 March 2022, the sponsor decided to terminate the BOSTON-4 safety and tolerability trial early. This decision was made after the Sponsor performed a careful and due diligent analysis of the current study status and considered the impact of the coronavirus disease 2019 (COVID-19) pandemic on-site activities.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Local Tolerability Events of Interest From Baseline to Visit 3 (Week 4) | at Week 4 (visit 3) | The local tolerability events of interest taken into consideration were: Cough, Wheezing, Bronchospasm, Throat irritation and Change from baseline in FEV1 to Visit 3. |
| Primary | Number of Participants With AE and sAE of Different Level of Severity During the First 4 Weeks of Treatment | During the first 4 weeks of treatment | An adverse event (AE) is any untoward medical occurrence after exposure to a medicine, which is not necessarily caused by that medicine. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A serious adverse event is an adverse event that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect. |
| Secondary | Number of Local Tolerability Events of Interest From Baseline to Week 12 | at Week 12 | The local tolerability events of interest taken into consideration were: Cough, Wheezing, Bronchospasm, Throat irritation and Change from baseline in FEV1 to Visit 3. |
| Secondary | Number of Participants With AE and sAE of Different Level of Severity During the First 12 Weeks of Treatment | During the first 12 weeks of treatment | An adverse event (AE) is any untoward medical occurrence after exposure to a medicine, which is not necessarily caused by that medicine. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A serious adverse event is an adverse event that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect. |
| Secondary | CsA Whole Blood Concentrations and CsA Whole Blood Trough Levels | Weeks 0 (pre-dose, directly after end of inhalation, 15, 30, 45, 60 min, 1.5 h, 2h, 4h), 2, 4, 8, and 12 | Whole Blood concentrations (Week 0) are at pre-dose, directly after end of inhalation, 15, 30, and 45 minutes, and 1, 1.5, 2, and 4 hours after end of inhalation, and whole blood trough levels (CsA concentration) at Weeks 2, 4, 8, and 12 were calculated. |
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 | Number of Local Tolerability Events of Interest From Baseline to Visit 3 (Week 4) | at Week 4 (visit 3) | The Safety Analysis Set (SAF) was defined as all randomized patients who had received a partial dose of IMP at least once. | number of local events | NUMBER |
| PRIMARY | Number of Participants With AE and sAE of Different Level of Severity During the First 4 Weeks of Treatment | During the first 4 weeks of treatment | The Safety Analysis Set (SAF) was defined as all randomized patients who had received a partial dose of IMP at least once. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Local Tolerability Events of Interest From Baseline to Week 12 | at Week 12 | The Safety Analysis Set (SAF) was defined as all randomized patients who had received a partial dose of IMP at least once. | number of events | NUMBER |
| SECONDARY | Number of Participants With AE and sAE of Different Level of Severity During the First 12 Weeks of Treatment | During the first 12 weeks of treatment | The Safety Analysis Set (SAF) was defined as all randomized patients who had received a partial dose of IMP at least once. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | CsA Whole Blood Concentrations and CsA Whole Blood Trough Levels | Weeks 0 (pre-dose, directly after end of inhalation, 15, 30, 45, 60 min, 1.5 h, 2h, 4h), 2, 4, 8, and 12 | The Full Analysis Set (FAS) was defined as all randomized patients for whom at least~1 post-baseline measurement of an efficacy outcome measure (ie, spirometry or quality of life measures) was available. For spirometry measures, baseline corresponded to the assessment at randomization visit (Visit 1) prior to inhalation of IMP. | ng/ml | MEAN |
Source ClinicalTrials.gov
Results by group135
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Local Tolerability Events of Interest From Baseline to Visit 3 (Week 4) | L-CsA 10 mg Plus Standard of Care | Any Local Tolerability Event | 1 | number of local events | |
| Number of Local Tolerability Events of Interest From Baseline to Visit 3 (Week 4) | L-CsA 5 mg Plus Standard of Care | Any Local Tolerability Event | 5 | number of local events | |
| Number of Local Tolerability Events of Interest From Baseline to Visit 3 (Week 4) | Liposomal Placebo Plus Standard of Care | Any Local Tolerability Event | 4 | number of local events | |
| Number of Local Tolerability Events of Interest From Baseline to Visit 3 (Week 4) | L-CsA 10 mg Plus Standard of Care | Cough | 0 | number of local events | |
| Number of Local Tolerability Events of Interest From Baseline to Visit 3 (Week 4) | L-CsA 5 mg Plus Standard of Care | Cough | 1 | number of local events | |
| Number of Local Tolerability Events of Interest From Baseline to Visit 3 (Week 4) | Liposomal Placebo Plus Standard of Care | Cough | 1 | number of local events | |
| Number of Local Tolerability Events of Interest From Baseline to Visit 3 (Week 4) | L-CsA 10 mg Plus Standard of Care | Wheezing | 0 | number of local events | |
| Number of Local Tolerability Events of Interest From Baseline to Visit 3 (Week 4) | L-CsA 5 mg Plus Standard of Care | Wheezing | 0 | number of local events | |
| Number of Local Tolerability Events of Interest From Baseline to Visit 3 (Week 4) | Liposomal Placebo Plus Standard of Care | Wheezing | 0 | number of local events | |
| Number of Local Tolerability Events of Interest From Baseline to Visit 3 (Week 4) | L-CsA 10 mg Plus Standard of Care | Bronchospasm | 0 | number of local events |
1 to 10 of 135Source ClinicalTrials.gov
See all 135 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | L-CsA 10 mg Plus Standard of Care | 2 | |
| Overall Study | STARTED | L-CsA 5 mg Plus Standard of Care | 2 | |
| Overall Study | STARTED | Liposomal Placebo Plus Standard of Care | 2 | |
| Overall Study | COMPLETED | L-CsA 10 mg Plus Standard of Care | 2 | |
| Overall Study | COMPLETED | L-CsA 5 mg Plus Standard of Care | 2 | |
| Overall Study | COMPLETED | Liposomal Placebo Plus Standard of Care | 2 | |
| Overall Study | NOT COMPLETED | L-CsA 10 mg Plus Standard of Care | 0 | |
| Overall Study | NOT COMPLETED | L-CsA 5 mg Plus Standard of Care | 0 | |
| Overall Study | NOT COMPLETED | Liposomal Placebo Plus Standard of Care | 0 |
Source ClinicalTrials.gov
Adverse events18
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 | Throat irritation | Respiratory, thoracic and mediastinal disorders | L-CsA 10 mg Plus Standard of Care | 1 | 2 | 1 |
| other | Throat irritation | Respiratory, thoracic and mediastinal disorders | L-CsA 5 mg Plus Standard of Care | 1 | 2 | 1 |
| other | Throat irritation | Respiratory, thoracic and mediastinal disorders | Liposomal Placebo Plus Standard of Care | 1 | 2 | 1 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | L-CsA 10 mg Plus Standard of Care | 0 | 2 | 0 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | L-CsA 5 mg Plus Standard of Care | 1 | 2 | 1 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Liposomal Placebo Plus Standard of Care | 1 | 2 | 1 |
| other | Productive cough | Respiratory, thoracic and mediastinal disorders | L-CsA 10 mg Plus Standard of Care | 0 | 2 | 0 |
| other | Productive cough | Respiratory, thoracic and mediastinal disorders | L-CsA 5 mg Plus Standard of Care | 1 | 2 | 1 |
| other | Productive cough | Respiratory, thoracic and mediastinal disorders | Liposomal Placebo Plus Standard of Care | 0 | 2 | 0 |
| other | Wheezing | Respiratory, thoracic and mediastinal disorders | L-CsA 10 mg Plus Standard of Care | 1 | 2 | 1 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | L-CsA 10 mg Plus Standard of Care | 0 | 2 |
| Total, all-cause mortality | L-CsA 5 mg Plus Standard of Care | 0 | 2 |
| Total, all-cause mortality | Liposomal Placebo Plus Standard of Care | 0 | 2 |
| Total, other adverse events | L-CsA 10 mg Plus Standard of Care | 2 | 2 |
| Total, other adverse events | L-CsA 5 mg Plus Standard of Care | 1 | 2 |
| Total, other adverse events | Liposomal Placebo Plus Standard of Care | 1 | 2 |
| Total, serious adverse events | L-CsA 10 mg Plus Standard of Care | 1 | 2 |
| Total, serious adverse events | L-CsA 5 mg Plus Standard of Care | 0 | 2 |
| Total, serious adverse events | Liposomal Placebo Plus Standard of Care | 0 | 2 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04107675
GET https://conductscience.org/api/trials/v1/NCT04107675/results?page=2