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.edu. Study 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	tracy.halaby@emory.edu
Brigham and Women’s–Harvard	Elizabeth Henske, MD	Shefali Bagwe	sbagwe@bwh.harvard.edu
Loyola University	Dan Dilling, MD	Josie Corral	jcorral@luc.edu
National Jewish Health	Gregory Downey, MD	Jami Henriksen	henriksenj@NJHealth.org
Stanford University Medical Center	Stephen Ruoss, MD	Susan Jacobs	ssjpulm@stanford.edu
Swedish Minor and James	George Pappas, MD, MPH	Julie Wallick	Julie.Wallick@swedish.org
University of Cincinnati	Frank McCormack, MD Nishant Gupta, MD	Susan McMahan	susan.mcmahan@uc.edu
University of Pennsylvania	Maryl Kreider, MD	Sara Deitrick	sara.deitrick@uphs.upenn.edu
Vanderbilt University	Lisa Young, MD	Errine Garnett	Errine.t.garnett@vanderbilt.edu