JPRN-jRCT2091220011已完成3 期
Multicenter International Lymphangioleiomyomatosis Efficacy of Sirolimus Trial (The MILES Trial) - MILES
Frank McCormack, M.D., University of Cincinnati Medical Center Director, Division of Pulmonary and Critical Care Medicine0 个研究点目标入组 120 人开始时间: 2007年6月29日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
Sirolimus inhibits the progression of LAM and stabilize the disease activity.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- Female
入选标准
- •1 Age 18 or over
- •2 Signed and dated informed consent
- •3 Diagnosis of LAM as determined by biopsy; or chest CT scan findings compatible with LAM in the setting of tuberous sclerosis, angiomyolipoma or chylous pleural effusion
- •4 Abnormal lung function i.e., postbronchodilator FEV1 less than or equal to 70% of predicted
排除标准
- •1 History of myocardial infarction or stroke related to atherosclerosis
- •2 Pregnancy or breast feeding
- •3 Inadequate contraception
- •4 Significant hematologic or hepatic abnormality
- •5 Intercurrent infection at initiation of sirolimus
- •6 Recent surgery (involving entry into a body cavity) within 2 months of initiation of sirolimus
- •7 Use of an investigational drug within the last 30 days
- •8 Uncontrolled hyperlipidemia
- •9 Previous lung transplantation
- •10 Inability to attend scheduled clinic visits
- •11 Inability to give informed consent
- •12 Inability to perform pulmonary function testing
- •13 Creatinine > 2.5 mg/dl
- •14 Chylous ascites sufficient to affect diaphragmatic function
- •15 Pleural effusion sufficient to affect pulmonary function
- •16 Acute pneumothorax within the past 2 months
- •17 Malignancy other than uncomplicated skin cancer in the past 2 years
- •18 Previous or current use of estrogen therapy
研究者
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