A Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A Inhalation Solution in the Treatment of Bronchiolitis Obliterans Syndrome in Patients Post Double Lung Transplant (BOSTON-2)
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|ClinicalTrials.gov Identifier: NCT03656926|
Recruitment Status : Recruiting
First Posted : September 4, 2018
Last Update Posted : February 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|Bronchiolitis Obliterans Chronic Rejection of Lung Transplant Lung Transplant Rejection Lung Transplant; Complications Lung Transplant Failure and Rejection||Drug: Liposomal Cyclosporine A||Phase 3|
Regardless of treatment allocation, all patients will continue to receive their SoC regimen for maintenance of the lung allograft. Eligible patients for the clinical trial must have a tacrolimus-based triple-drug therapy in combination with mycophenolate mofetil or its equivalent and a corticosteroid.
A total of 11 visits will be performed during the clinical trial. After informed consent has been obtained, a Screening Visit will be carried out in order to check general eligibility for participation. At the Randomization Visit, inclusion and exclusion criteria will be re-checked and spirometry performed. During the 48-week treatment period, visits are scheduled every 4-8 weeks. If a patient has an event that meets one of the criteria for progression of BOS, he/she will return to the clinic within 2-weeks for an unscheduled visit to have spirometry and other procedures performed.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Effectiveness and Safety of Liposomal Cyclosporine A (L-CsA) Inhalation Solution Delivered Via the PARI Investigational eFlow® Device Plus Standard of Care Versus Standard of Care Alone in the Treatment of Bronchiolitis Obliterans Syndrome in Patients Post Double Lung Transplantation|
|Actual Study Start Date :||March 29, 2019|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||July 2023|
Experimental: L-CsA treatment plus SoC
L-CsA 10 mg twice daily for 48 weeks, plus Standard of Care Therapy
Drug: Liposomal Cyclosporine A
delivered via the PARI eFlow® Device
No Intervention: Standard of Care alone
Standard of Care Therapy
- Mean change in FEV1 (mL) from baseline to Week 48) [ Time Frame: Baseline to Week 48 ]
- Mean change in FEV1/FVC from baseline to Week 48 [ Time Frame: Baseline to Week 48 ]
- Tiime to Progression of BOS [ Time Frame: 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 52 weeks. ]
defined as the earliest of the following:
- Absolute decrease from baseline in FEV1 >/= 10% or >/= 200 mL and absolute decrease in FEV1/FVC of > 5% OR
- Change in BOS Severity, OR
- Re-transplantation, OR
- Death from respiratory failure. This endpoint will be assessed in a combined analysis with a similar Phase III clinical trial, BT - L-CsA - 301 - SLT (BOSTON-1) which will be conducted in the same investigational centers in patients who have undergone single-lung transplantations.
- Adverse Events [ Time Frame: Baseline through study completion (52 weeks) ]
- Acute tolerability of L-CsA [ Time Frame: Baseline through Week 48 ]Change in forced expiratory volume in one second (FEV1); reports of cough or shortness of breath
- Hematology and Serum Chemistry Parameters [ Time Frame: From date of randomization until end of study participation (52 weeks) ]Number of patients with treatment-related changes in hematology or serum chemistry parameters assessed by CTCAE v5.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03656926
|Contact: Stefanie Prante Fernandes, MSc||+49 (0)159 email@example.com|
|Contact: Magda Berjas, MScfirstname.lastname@example.org|
|Study Director:||Paola Castellani, MD||Zambon SpA, Chief Medical Officer|