Phase II Trial of Zileuton Compared to Azathioprine/Prednisone for the Treatment of Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- LTB4 level in BAL
研究概览
简要总结
Open label trial of zileuton compared to azathioprine/prednisone for patients with idiopathic pulmonary fibrosis. Study subjects will undergo a detailed clinical, radiographic, and physiologic assessment at baseline. Subjects will be monitored off treatment for three months for changes in symptoms and physiology. Subjects will then be randomized to six months of treatment with zileuton or azathioprine/prednisone. The primary endpoint of this trial is change in LTB4 levels in bronchoalveolar lavage fluid following six months of treatment. Secondary endpoints are progression free survival, change in dyspnea, change in quality of life, and change in physiology.
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
- None
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic pulmonary fibrosis
- •Taking < 15 mg prednisone for at least 30 days prior to screening
- •Age 35-80, inclusive
- •Able to understand a written informed consent and comply with the study protocol
排除标准
- •Significant environmental exposure
- •Diagnosis of collagen vascular disease
- •Evidence of active infection
- •Clinically significant cardiac disease Myocardial infarction, coronary artery bypass or angioplasty within 6mo Unstable angina pectoris Congestive heart failure requiring hospitalization within 6 months Uncontrolled arrhythmia
- •Poorly controlled or severe diabetes mellitus
- •Pregnancy or lactation
- •Women of childbearing potential not using a medically approved means of contraception (i.e. oral contraceptives, intrauterine devices, diaphragm, Norplant)
- •Current enrollment in another experimental protocol
- •Physiologic Criteria:
- •FEV1/FVC < 0.60
- •Laboratory Criteria:
- •Total bilirubin > 1.5 X upper limit normal
- •AST or ALT > 3X upper limit normal
- •Alkaline phosphatase > 3X upper limit normal
- •White blood cell count < 2,500/mm3
- •Hematocrit < 30%
- •Platelets < 100,000/mm3
- •Prothrombin time INR > 1.5
研究组 & 干预措施
zileuton
Zileuton
干预措施: zileuton (Drug)
azathioprine/prednisone
azathioprine/prednisone
干预措施: azathioprine/prednisone (Drug)
结局指标
主要结局
LTB4 level in BAL
时间窗: 6 months
次要结局
- CRP score(6 months)
研究者
Kevin R. Flaherty
Professor of Medicine
University of Michigan