NCT00755781已完成3 期
A Multi-Center, Randomized, Controlled Study to Demonstrate the Efficacy and Safety of Cyclosporine Inhalation Solution (CIS) in Improving Bronchiolitis Obliterans Syndrome-Free Survival Following Lung Transplantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 284
- 试验地点
- 19
- 主要终点
- Duration of BOS-free survival. Other causes for the decline should be excluded by bronchoscopy and other diagnostic testing performed at the discretion of the investigator. The diagnosis of BOS will be determined by the Outcomes Committee
研究概览
简要总结
A Phase III, multi-center, randomized, controlled study designed to demonstrate the efficacy and safety of Cyclosporine Inhalation Solution (CIS)in improving survival and preventing bronchiolitis obliterans syndrome (BOS) when given prophylactically to lung transplant recipients in addition to their standard immunosuppressive regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A recipient of a single or double lung transplant (including heart-lung transplant)
- •Age 18 years or older
- •Able to produce a forced expiratory volume in one second (FEV1) of greater than one liter at randomization
- •Eligible subjects must be enrolled within 70 days after receiving a lung transplant
- •Clinical status sufficiently stable to enable routine post-transplant bronchoscopy with bronchoalveolar lavage (BAL) and chest X-ray (or equivalent i.e., chest computerized tomogram (CT)) prior to screening
排除标准
- •Lung re-transplantation
- •Documented allergy to propylene glycol and/or cyclosporine
- •Documented respiratory or anastomotic infections unless on appropriate antimicrobial therapy with evidence of clinical response
- •Women who are pregnant, wishing to become pregnant, or unwilling to use appropriate birth control to avoid becoming pregnant
- •Women who are breastfeeding
- •Clinically significant bronchial stenosis unresponsive to dilation and/or stenting
- •Malignancies diagnosed within one year prior to screening (with the exception of non-melanomatous skin cancers)
研究组 & 干预措施
CIS
Active Comparator
CIS in addition to standard immunosuppressive regimen.
干预措施: Cyclosporine Inhalation Solution (CIS) (Drug)
结局指标
主要结局
Duration of BOS-free survival. Other causes for the decline should be excluded by bronchoscopy and other diagnostic testing performed at the discretion of the investigator. The diagnosis of BOS will be determined by the Outcomes Committee
时间窗: Assessed when symptoms of syndrome present
次要结局
- Pulmonary function as measured by mean FEV1 percent predicted at 2 years after randomization(From study initiation through 2+ years after randomization)
- All cause mortality(From study initiation through 2+ years after randomization)
- Duration of event-free survival, corresponding to the length of time between date of randomization and either death or the occurrence of serious bacterial and viral infections that start in the lungs (defined by reporting of a SAE)(From study initiation through 2+ year after randomzation)
研究者
研究点 (19)
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