EUCTR2018-003205-25-DE进行中（未招募）1 期
A Phase III, Prospective, Multicenter, Randomized, Controlled Clinical Trialto Demonstrate the Efficacy and Safety of Liposomal Cyclosporine A (LCsA)Inhalation Solution Delivered via the PARI Investigational eFlow®Device plus Standard of Care versus Standard of Care Alone in theTreatment of Chronic Lung Allograft Dysfunction / Bronchiolitis ObliteransSyndrome in Patients post Double Lung Transplantation - BOSTON-2
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
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 posttransplant.
- •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
- •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
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