Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-2) (BOSTON-2)
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|ClinicalTrials.gov Identifier: NCT03656926|
Recruitment Status : Recruiting
First Posted : September 4, 2018
Last Update Posted : March 31, 2022
|Condition or disease||Intervention/treatment||Phase|
|Bronchiolitis Obliterans Chronic Rejection of Lung Transplant Lung Transplant Rejection Lung Transplant; Complications Lung Transplant Failure and Rejection Chronic Lung Allograft Dysfunction||Drug: Liposomal Cyclosporine A Drug: Standard of Care||Phase 3|
This is a Phase III randomized, controlled clinical trial of L-CsA for the treatment of bronchiolitis obliterans syndrome in adults diagnosed with BOS following double lung transplant. Patients will receive either L-CsA (10 mg) via the PARI Investigational eFlow® Device twice daily plus Standard of Care (SoC) treatment, or SoC alone, for a period of 48 weeks. All patients will be eligible to continue in an open-label extension trial of L-CsA following completion of BOSTON-2.
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 at least 2-weeks later for an unscheduled visit to have spirometry and other procedures performed.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||152 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Phase III Clinical Trial to Demonstrate Efficacy / Safety of Liposomal Cyclosporine A + Standard of Care (SoC) vs SoC Alone in Treating Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans in Patients Post Double Lung Transplant|
|Actual Study Start Date :||March 29, 2019|
|Estimated Primary Completion Date :||August 2023|
|Estimated Study Completion Date :||September 2023|
Experimental: L-CsA treatment plus SoC
Liposomal Cyclosporine A (L-CsA) 10 mg twice daily for 48 weeks, plus Standard of Care Therapy
Drug: Liposomal Cyclosporine A
This formulation is developed for inhalation use and delivered via the PARI eFlow® Device, which is a new technology of nebulizing liquid drugs with a perforated vibrating membrane resulting in an aerosol with a low ballistic momentum and a high percentage of droplets in a respirable size range of 3-5 μm
Other Name: L-CsA
Active Comparator: Standard of Care
This is a maintenance regimen of immunosuppressive agents
Drug: Standard of Care
Standard of Care Therapy. Eligible patients should be on a maintenance regimen of immunosuppressive agents including tacrolimus, a second agent such as but not limited to MMF or azathioprine, and a systemic corticosteroid such as prednisone as third agent. The regimen must be stable within 4 weeks prior to randomization with respect to the therapeutic agents. Patients receiving azithromycin for prophylaxis or treatment of BOS, must be on a stable regimen for a least 4-weeks prior to randomization and will continue to receive azithromycin during the trial as deemed appropriate by the investigator
Other Name: SoC
- 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: Ferdinando Ceravolo, MD||+39 02 firstname.lastname@example.org|
|Study Director:||Paola Castellani, MD||Zambon SpA, Chief Medical Officer|