Phase 2 Study of Long Acting Octreotide in Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 16
- 主要终点
- FVC changes
研究概览
简要总结
Octreotide is a somatostatin analog with a long half-life in vivo. Octreotide has interesting anti-inflammatory and anti-fibrotic properties in vitro and in vivo. Somatostatin receptors are increased and Octreotide uptake is increased in the lung in patients with idiopathic pulmonary fibrosis. Our hypothesis is that octreotide may slow the degradation of lung function in patients with IPF. In this proof of concept study, patients with IPF will receive an intramuscular injection of slow release octreotide (Sandostatin LP, 30 mg)every 4 weeks for 48 weeks. Lung function (FVC, DLCO), HRCT scores for fibrosis and ground glass, 6 minute walking test,quality of life and survival will be monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confident diagnosis of IPF according to ATS/ERS criteria
排除标准
- •known intolerance to somatostatin or octreotide
- •another disease with predicted survival < 12 months
- •pregnancy or lactation
- •previous treatment with somatostatin or somatostatin analogs
- •patient on a waiting list for transplantation
- •antifibrotic treatment or prednisone > 10 mg/day within the last 6 weeks
- •symptomatic biliary lithiasis
- •blood coagulation disorders that prevent intra-muscular injections
- •HIV infection
- •hepatitis B or C active infection
研究组 & 干预措施
octreotide
octreotide SR 30 mg intra muscularly every 4 weeks
干预措施: octreotide (Drug)
结局指标
主要结局
FVC changes
时间窗: 12 months
次要结局
- DLCO changes(12 months)