Trial · NCT03656926

Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Double Lung Transplant (BOSTON-2)

NCT03656926, Phase 3, Completed, Zambon SpA; results first posted 2025-07-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Double Lung Transplant (BOSTON-2). Trials, record NCT03656926. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03656926

On this page

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 Double Lung Transplant (BOSTON-2)
NCT number: NCT03656926
Status: Completed
Phases: Phase 3
Enrollment: 169 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: 2018-09-04
Last updated: 2026-02-10
Other registries' IDs: eudract:2018-003205-25
Results first posted: 2025-07-24

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 (Liters) From Baseline to Week 48	Week 48	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.
Secondary	Mean Change in FEV1/ Forced Vital Capacity (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, 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.	Time to progression of BOS, defined as the earliest of the following: * Absolute decrease from Baseline in FEV1 ≥10% or ≥ 200 mL (0.2 L) and absolute decrease in FEV1/FVC of \> 5% OR * Worsening of BOS grade, OR * Re-transplantation, OR * Death from respiratory failure. 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	Acute Tolerability of L-CsA: FEV1 Change From Pre-dose to 1 Hour and 4 Hours Post-dose	Pre-dose and 1- and 4-hours post-dose on Visit 1	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.
Other	Count of Participants With at Least One Adverse Event (AE)	Baseline through study completion (52 weeks)	An untoward medical occurrence after exposure to a medicine, which is not necessarily caused by that medicine.

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 (Liters) From Baseline to Week 48	Week 48	Full analysis set: The FAS was defined as all randomized patients. Patients were analyzed according to the treatment group to which they were randomized. Please note that N = number of patients in analysis set (N=84 for L-CSA + SoC and N=85 for SoC alone); n = number of patients with data available (n=64 for L-CSA + SoC and n=80 for SoC alone)	Liters	LEAST_SQUARES_MEAN
SECONDARY	Mean Change in FEV1/ Forced Vital Capacity (FVC) From Baseline to Week 48	Week 48	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. The number of patients with data available (n) for this outcome was 64 for L-Csa + SoC and 80 for SoC alone, while the number of patients (N) in the FAS is 84 and 85 respectively.	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.	Full analysis set: The FAS was defined as all randomized patients. Patients were analyzed according to the treatment group to which they were randomized.	weeks	MEDIAN
OTHER_PRE_SPECIFIED	Acute Tolerability of L-CsA: FEV1 Change From Pre-dose to 1 Hour and 4 Hours Post-dose	Pre-dose and 1- and 4-hours post-dose on Visit 1	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. Please note that only 77 patients had available data at 1 hour after treatment and only 72 had data 4h after treatment.	Liters	MEAN
OTHER_PRE_SPECIFIED	Count of Participants With at Least One Adverse Event (AE)	Baseline through study completion (52 weeks)	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.~Independently of the treatment allocation at randomization, patients were analyzed according to the treatment they actually received.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group26

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 (Liters) From Baseline to Week 48	L-CsA Treatment Plus SoC - FAS		-0.096	Standard Error 0.1120	Liters
Mean Change in FEV1 (Liters) From Baseline to Week 48	Standard of Care - FAS		-0.067	Standard Error 0.1147	Liters
Mean Change in FEV1/ Forced Vital Capacity (FVC) From Baseline to Week 48	L-CsA Treatment Plus SoC - FAS		-0.100	Standard Error 0.0722	ratio
Mean Change in FEV1/ Forced Vital Capacity (FVC) From Baseline to Week 48	Standard of Care - FAS		-0.083	Standard Error 0.0702	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)	Standard of Care - FAS		NA	95% Confidence Interval NA to NA	weeks
Acute Tolerability of L-CsA: FEV1 Change From Pre-dose to 1 Hour and 4 Hours Post-dose	L-CsA Treatment Plus SoC - SAF	1h post-dose	-0.019	Standard Deviation 0.0855	Liters
Acute Tolerability of L-CsA: FEV1 Change From Pre-dose to 1 Hour and 4 Hours Post-dose	L-CsA Treatment Plus SoC - SAF	4h post-dose	-0.005	Standard Deviation 0.0914	Liters
Count of Participants With at Least One Adverse Event (AE)	L-CsA Treatment Plus SoC - SAF	with any TEAE	73		Participants
Count of Participants With at Least One Adverse Event (AE)	Standard of Care SAF	with any TEAE	77		Participants

1 to 10 of 26Source ClinicalTrials.gov

See all 26 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	L-CsA Treatment Plus SoC	84
Overall Study	STARTED	Standard of Care	85
Overall Study	Full analysis set	L-CsA Treatment Plus SoC	84
Overall Study	Full analysis set	Standard of Care	85
Overall Study	Safety analysis set	L-CsA Treatment Plus SoC	84
Overall Study	Safety analysis set	Standard of Care	85
Overall Study	Per protocol set	L-CsA Treatment Plus SoC	46
Overall Study	Per protocol set	Standard of Care	70
Overall Study	COMPLETED	L-CsA Treatment Plus SoC	69
Overall Study	COMPLETED	Standard of Care	79

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events716

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	23	84	23
other	COVID-19	Infections and infestations	Standard of Care - SAF	21	85	23
other	Bronchitis	Infections and infestations	L-CsA Treatment Plus SoC - SAF	8	84	9
other	Bronchitis	Infections and infestations	Standard of Care - SAF	5	85	6
other	Nasopharyngitis	Infections and infestations	L-CsA Treatment Plus SoC - SAF	6	84	7
other	Nasopharyngitis	Infections and infestations	Standard of Care - SAF	8	85	9
other	COVID-19 pneumonia	Infections and infestations	L-CsA Treatment Plus SoC - SAF	5	84	5
other	COVID-19 pneumonia	Infections and infestations	Standard of Care - SAF	1	85	1
other	Gastroenteritis	Infections and infestations	L-CsA Treatment Plus SoC - SAF	5	84	5
other	Gastroenteritis	Infections and infestations	Standard of Care - SAF	1	85	1

1 to 10 of 716Source ClinicalTrials.gov

See all 716 adverse events

Adverse 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	2	84
Total, all-cause mortality	Standard of Care - SAF	4	85
Total, other adverse events	L-CsA Treatment Plus SoC - SAF	73	84
Total, other adverse events	Standard of Care - SAF	77	85
Total, serious adverse events	L-CsA Treatment Plus SoC - SAF	46	84
Total, serious adverse events	Standard of Care - SAF	44	85

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 Standard of Care - SAF: deaths from any cause	Trial comparisons
L-CsA Treatment Plus SoC - SAF vs Standard of Care - 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT03656926

GET https://conductscience.org/api/trials/v1/NCT03656926/results?page=2

API reference For AI assistants