Start Early. The MILED Trial is seeking answers to an important clinical question: If we start sirolimus early, can we maintain normal lung function?

 

The Multicenter Interventional Lymphangioleiomyomatosis Early Disease (MILED) Trial is a new research study designed to answer the question of whether we should be starting sirolimus at low doses earlier in the course of disease, before symptoms develop and while lung function is still normal. It is led by Dr. McCormack at the University of Cincinnati and is being conducted at select LAM Clinics located across the country in Atlanta, Boston, Denver, Chicago, Cincinnati, Nashville, Philadelphia, Seattle and Stanford. Reimbursement for travel is available for participants to attend study visits.  

Potential participants are: 

  • Adult women with a LAM diagnosis 
  • With an FEV1 of > 70% 
  • Not currently taking sirolimus 

What to Expect during MILED

Participants in the research study will: 

  • Attend 8 study visits over 2 years (about one visit every 4 months) 
  • Complete blood tests, a physical exam, and pulmonary function tests at visits 
  • Answer questions about breathing, fatigue and quality of life  

Study Drug 

The study is a double blind, placebo controlled trial. This means that study participants will have a 50/50 chance of getting a placebo instead of sirolimus. Participants will not know what they have received and neither will their study doctors until the study is complete. MILED participants will be given study medicine (1 mg sirolimus or a placebo) with instructions to take one pill every day and to record their pill taking and any side effects they may experience. The study staff will stay in contact between visits to monitor safety. 


To ask questions or see if you may be eligible to participate in the MILED Trial 

Please contact Susan McMahan, BSN, RN, Project Manager for the MILED Trial, at the University of Cincinnati. She will be able to answer your questions and refer you to the study location most convenient for you. Susan can be reached at 513-558-4376 or susan.mcmahan@uc.eduStudy information is also available on clinicaltrials.gov


Travel Expenses   

Reasonable travel expenses to enable participants to get to and from study visits will be supplied by The LAM Foundation. To learn more about travel expense support, download the MILED Trial Travel Policy or call us at 513-777-6889.  


MILED Trial Sites and Contact Informationplus


Site

Principal Investigator (PI)

Research Staff

CRC Contact Information

Emory University

Srihari Veeraraghavan,MD

 

Tracy Halaby

Brigham and Women’sHarvard

 

Elizabeth Henske, MD

Shefali Bagwe

Loyola University

 

Dan Dilling, MD

Josie Corral

National Jewish Health

Gregory Downey, MD

Jami Henriksen

Stanford University Medical Center

 

Stephen Ruoss, MD

Susan Jacobs

 

Swedish Minor and James

 

George Pappas, MD, MPH

Julie Wallick

University of Cincinnati

 

Frank McCormack, MD

Nishant Gupta, MD

Susan McMahan

University of Pennsylvania

 

Maryl Kreider, MD

Sara Deitrick

Vanderbilt University

 

Lisa Young, MD

Errine Garnett