Multicenter International Lymphangioleiomyomatosis Efficacy of Sirolimus Trial (The MILES Trial)
- Conditions
- ymphangioleiomyomatosis (LAM)
- Registration Number
- JPRN-jRCT2091220011
- Lead Sponsor
- Frank McCormack, M.D., University of Cincinnati Medical Center Director, Division of Pulmonary and Critical Care Medicine
- Brief Summary
Sirolimus inhibits the progression of LAM and stabilize the disease activity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 120
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method