A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trial to Demonstrate the Efficacy 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 Chronic Lung Allograft Dysfunction / Bronchiolitis Obliterans Syndrome in Patients post Double Lung Transplantation - BOSTON-2

Zambon SpA0 个研究点目标入组 170 人开始时间: 2021年9月28日最近更新: 2024年7月8日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Zambon SpA
入组人数: 170

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Adult patients of = 18 years who received a double lung transplant at least 12 months prior to Screening.
•2. Patients with BOS diagnosis defined as CLAD-BOS phenotype with:
•a) Screening FEV1 between 85-51% of personal best FEV1 value post-transplant.
•b) Screening FEV1 >85% of personal best FEV1 associated with EITHER a = 200 mL decrease in FEV1 in the previous 12 months OR according to medical history showing BOS progression.
•3. Diagnosis of CLAD-BOS must be made at least 12 months after lung transplantation and
•a) within 12 months prior to the screening visit.
•b) more than 12 months from screening and patient must have shown a decline in FEV1 = 200ml in the previous 12 months before screening, which is not due to acute infection or acute organ rejection.
•4. Patients in whom the diagnosis of BOS has been confirmed by the elimination of other possible causes of obstructive or restrictive lung disease (CLAD – RAS phenotype, see Protocol Specific Definitions).
•5. Patients should be on a drug 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. In case a patient is also receiving concomitant azithromycin for prophylaxis or treatment of BOS, in addition to the previously described immunusuppresive regimen , azythromicin regimen must be on a stable regimen for a least 4-weeks prior to randomization.
•6. Patients capable of understanding the purposes and risks of the clinical trial, who have given written informed consent and agree to comply with the clinical trial requirements/visit schedules, and who are capable of aerosol inhalation. Patients must consent to retrieve prespecified data from the historic medical record (e.g., information related to the transplant surgery; spirometry data; medication use).
•7. Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to randomization and must agree to use one of the methods of contraception listed in Appendix II of the protocol through their End of Study Visit.
•8. Patients have no concomitant diagnoses that are considered fatal within one year (12 months) of Screening.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 120
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

排除标准

•1. Patients with confirmed other causes for loss of lung function, such as acute infection, acute rejection, restrictive allograft syndrome (CLAD – RAS phenotype, see Protocol Specific Definitions),etc.
•2. Cystic Fibrosis patients with multi-drug resistant infections not responding to available anti-microbial therapies.
•3. Patients with acute antibody-mediated rejection at Screening. In this context, clinically stable patients (as judged by the Investigator) with detectable levels of donor specific antibodies (DSA) at the Screening Visit are eligible for the study.
•4. Active bacterial, viral, or fungal infection not successfully resolved at least 4 weeks prior to the Screening Visit. Patients with chronic infection or colonization who are clinically stable as per judgement of the Investigator are eligible for the study
•5. Mechanical ventilation (including CPAP) within 12 weeks prior to Randomization.
•6. Patients with uncontrolled hypertension.
•7. Patient has baseline resting oxygen saturation of < 89% on room air or use of supplemental oxygen at rest.
•8. Evidence of functional airway stenosis (e.g., bronchomalacia/tracheomalacia, airway stents, or airways requiring balloon dilatations to maintain patency) with onset after the initial diagnosis of BOS and ongoing at Screening and/or Randomization Visit.
•9. Known hypersensitivity to L-CsA or cyclosporine A.
•10. Patients with chronic renal failure defined as serum creatinine > 2.5 mg/dL at screening or requiring chronic dialysis.
•11. Patients with liver disease and serum bilirubin > 3-fold upper limit of normal range or transaminases > 2.5 upper limit of normal range.
•12. Patients with active malignancy within the previous 2 years, including post-transplant lymphoproliferative disorder, with the exception of treated, localized basal and squamous cell carcinomas.
•13. Pregnant women or women who are unwilling to use appropriate birth control to avoid pregnancy through their End of Study Visit.
•14. Women who are currently breastfeeding.
•15. Receipt of an investigational drug as part of a clinical trial within 4 weeks prior to the Screening Visit. This is defined as any treatment that is implemented under an Investigational New Drug (IND) or compassionate use.
•16. Patients who have received extracorporeal photophoresis (ECP) for treatment of BOS within 1 month prior to Randomization.
•17. Patients who are currently participating in an interventional clinical trial.
•18. Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures.
•19. Any co-existing medical condition that in the Investigator’s judgment will substantially increase the risk associated with the patient’s participation in the clinical trial.

研究者

发起方

Zambon SpA

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