EUCTR2018-003204-39-ES进行中（未招募）1 期
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 Single Lung Transplantation - BOSTON-1
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 130
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
入选标准
- •1. Adult patients of = 18 years.
- •2. Patients with diagnosis of BOS Grade 0-p with screening FEV1 between 85-81% of personal best FEV1 value post transplant plus risk factors as defined below, OR BOS Grade 1 with screening FEV1 between 80-66% of personal best FEV1 value post-transplant. Patients with a diagnosis of BOS Grade 0-p must have = 2 of these risk factors for BOS:
- •- Primary graft dysfunction (PGD)
- •- Acute cellular rejection
- •- Lymphocytic bronchiolitis
- •- Humoral rejection (e.g. de novo anti-human leukocyte antigen antibodies)
- •- Gastro-oesophageal reflux and microaspiration
- •- Infection (Viral, Bacterial, Fungal)
- •- Persistent neutrophil influx and sequestration (bronchoalveolar lavage neutrophilia)
- •- Autoimmunity (collagen V sensitization).
- •3. Patients with an FEV1/FVC ratio of < 0.8.
- •4. Patients in whom the diagnosis of BOS has been confirmed by the elimination of other possible causes of obstructive lung disease.
- •5. Patients with a diagnosis of BOS 0-p or BOS 1 made at least 1 year after transplant surgery and within 6 months prior to the Screening Visit.
- •6. Patients receiving a tacrolimus-based basic immunosuppression regimen in combination with MMF (or equivalent) and corticosteroids. This basic immunosuppression regimen must be stable (without changes to doses) for at least 4-weeks prior to Randomization.
- •7. Patients must consent to retrieve prespecified data from the historic medical record (e.g., information related to the transplant surgery; spirometry data; medication use).
- •8. Patients must be receiving prophylaxis against Cytomegalovirus (CMV) and Pneumocystis pneumonia.
- •9. 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.
- •10. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization and must agree to use one of the methods of contraception listed in Appendix II for their duration of clinical trial participation.
- •11. Patients have no concomitant diagnoses that are considered fatal within one year (12 months).
- •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 95
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •1. Patients with confirmed other causes for loss of lung function, such as infection, acute rejection, restrictive allograft syndrome (RAS), etc.
- •2. Patients with Cystic Fibrosis.
- •3. Patients with donor-specific antibody (DSA) positivity at the Screening Visit.
- •4. Active bacterial, viral, or fungal infection not successfully resolved at least 4 weeks prior to the Screening Visit.
- •5. Mechanical ventilation within 12 weeks prior to Randomization.
- •6. Patient has baseline resting oxygen saturation of < 89% on room air or use of supplemental oxygen.
- •7. History or presence of bronchial strictures or airway stents or airways requiring balloon dilatations to maintain patency.
- •8. Known hypersensitivity to L-CsA or to cyclosporine A.
- •9. Patients with chronic renal failure defined as serum creatinine > 2.5 mg/dL or requiring chronic dialysis.
- •10. Patients with liver disease and serum bilirubin > 3-fold upper normal value or transaminases > 2.5 upper normal value.
- •11. Patients with a history of malignancy, including post-transplant lymphoproliferative disorder, with the exception of treated, localized basal and squamous cell carcinomas.
- •12. Pregnant women or women who are unwilling to use appropriate birth control to avoid pregnancy over the course of the clinical trial.
- •13. Women who are currently breastfeeding.
- •14. 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.
- •15. Patients who have received extracorporeal photophoresis (ECP) for treatment of BOS within 2 months prior to Randomization.
- •16. Patients who are currently participating in an interventional clinical trial.
- •17. Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures.
- •18. 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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