Cyclophosphamide Added to Corticosteroid in the Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis: a Placebo-controlled Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- "Early" survival
研究概览
简要总结
Acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) is a major event of IPF with an annual incidence between 5 and 10% and is responsible for the death of one third of IPF patients. When AE-IPF occurs, it is associated with poor survival with an overall mortality at 3 months upper of 50%. To date, no treatment has been proved to be effective in AE-IPF but the efficacy of cyclophosphamide (CYC) on survival has been suggested, mainly by retrospective series and needs to be confirmed. This confirmation is mandatory to improve prognosis of AE-IPF but also to avoid unsuspected deleterious effect as it as been shown with immunosuppressor in stable IPF.
详细描述
Acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) is a major event of IPF with an annual incidence between 5 and 10% and is responsible for the death of one third of IPF patients. When AE-IPF occurs, it is associated with poor survival with an overall mortality at 3 months upper of 50%. To date, no treatment has been proved to be effective in AE-IPF but the efficacy of CYC on survival has been suggested, mainly by retrospective series and needs to be confirmed. This confirmation is mandatory to improve prognosis of AE-IPF but also to avoid unsuspected deleterious effect as it as been shown with immunosuppressor in stable IPF.
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
- Double (Participant, Investigator)
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
- 未提供
排除标准
- •Identified etiology for acute worsening (i.e. infectious disease)
- •Known hypersensitivity or contra-indication to CYC or to any component of the study treatment
- •Patient on mechanical ventilation
- •Active bacterial, viral, fungal or parasitic infection
- •Active cancer
- •Patient on a lung transplantation waiting list
- •Treatment with CYC in the last 12 months
- •Patient participating to another clinical trial
- •Pregnancy or lactation
研究组 & 干预措施
Corticosteroid with placebo
Population is IPF patients with an AE who meet the inclusion and exclusion criteria defined below.
All patients will receive non experimental medication with high dose of corticosteroid.
干预措施: Placebo (Drug)
Corticosteroid with placebo
Population is IPF patients with an AE who meet the inclusion and exclusion criteria defined below.
All patients will receive non experimental medication with high dose of corticosteroid.
干预措施: Corticosteroid (prednisolone) (Drug)
Corticosteroid associated with Cyclophosphamide
Population is IPF patients with an AE who meet the inclusion and exclusion criteria defined below.
All patients will receive non experimental medication with high dose of corticosteroid.
Intravenous Cyclophosphamide (CYC), 600 mg/m² (adapted to age and renal function, maximal dose of 1.2 g) at Day 0, Day 15, M1, M2
干预措施: Cyclophosphamide (Drug)
Corticosteroid associated with Cyclophosphamide
Population is IPF patients with an AE who meet the inclusion and exclusion criteria defined below.
All patients will receive non experimental medication with high dose of corticosteroid.
Intravenous Cyclophosphamide (CYC), 600 mg/m² (adapted to age and renal function, maximal dose of 1.2 g) at Day 0, Day 15, M1, M2
干预措施: Corticosteroid (prednisolone) (Drug)
结局指标
主要结局
"Early" survival
时间窗: 3 months
All cause of mortality at 3 months
次要结局
- Diabetes mellitus (capillary blood glucose monitoring and fasting plasma glucose > 1.26 g/l)(6 months)
- Respiratory disease-specific mortality(6 months)
- Prognosis factors of AE-IPF(3 months)
- Clinical laboratory evaluation (blood count, serum creatinin measurement composite) according to Common Terminology Criteria for Adverse Event (CTCAE).(6 months)
- Overall Survival(6 months and 12 montns)
- Respiratory Morbidity(6 months)
- Time to visit after clinical worsening(3 months)
- Hemorrhagic cystitis (occurence of hematuria on urine dipstick and pelvic pain and/or dysuria should lead to cystoscopy)(6 months)
- Chest HRCT features (HRCT images will be scored at 5 levels)(6 months)
- Time to dispense treatment of AE-IPF(3 months)
- Hypertension (Blood pressure > 160/100 mmHg)(6 months)
- Laboratory evaluation (LDH, CRP) at AE diagnosis (composite)(3 months)
- Number of Infectious disease(6 months)