A Randomized, Double Blind, Placebo Controlled Trial With Montelukast to Treat Bronchiolitis Obliterans Syndrome After Lung Transplantation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- survival/retransplantation rate at 2 years after diagnosis
研究概览
简要总结
Chronic rejection (or Bronchiolitis Obliterans syndrome-BOS) is a major cause of mortality and morbidity after lung transplantation. Because montelukast has been shown to be of some efficacy in a similar disease (Obliterative Bronchiolitis after bone marrow transplantation), the investigators would like to test if montelukast can indeed slow down the progression of chronic rejection after lung transplantation.
详细描述
- Prospective, interventional, randomized, double-blind, placebo-controlled trial.
- Clinical setting (tertiary University Hospital).
- Investigator-driven, no pharmaceutical sponsor.
- Lung transplant recipients.
- Add-on of study-drug (placebo or montelukast) to 'standard of care'
- 1:1 inclusion ratio (placebo:montelukast).
- Randomisation at diagnosis of chronic rejection after informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of fBOS
- •Signed informed consent
- •Age at least 18 years old at moment of transplantation
- •Able to take oral medication
排除标准
- •Retransplantation
- •Previous organ transplantation
- •Multi organ transplantation
研究组 & 干预措施
montelukast sodium
Daily treatment with 10 mg montelukast after diagnosis of fibroproliferative BOS (fBOS) which is the low neutrophilic phenotype within BOS
干预措施: Montelukast (Drug)
placebo
Lactose monohydricum Ph.Eur.
干预措施: Montelukast (Drug)
结局指标
主要结局
survival/retransplantation rate at 2 years after diagnosis
时间窗: 2 years after diagnosis
survival/retransplantation rate after diagnosis of BOS
时间窗: 1 year after diagnosis
次要结局
- Obstructive and restrictive pulmonary function evolution(during 1 and 2 years of treatment)
- Bronchoalveolar lavage fluid (BAL)(during 1 and 2 years of treatment)
- peripheral blood(during 1 and 2 years of treatment)
- Cytomegalovirus (CMV) and non-CMV infection rates(during 1 and 2 years of follow up)
- Acute rejection and lymphocytic bronchiolitis rates(after 1 and 2 years of treatment)
研究者
Geert Verleden
Prof
Universitaire Ziekenhuizen KU Leuven