Please circulate the following to your patients with lymphangioleiomyomatosis (LAM):
The 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. The study is being conducted at several LAM Clinics located across the country in Cincinnati, Chicago, Atlanta, Seattle, and New York City. Reimbursement for travel is available for participants to attend study visits.
Eligible participants:
- Adult women with a LAM diagnosis
- Normal lung function (defined as FEV1 of > 70%)
- Not currently taking sirolimus
What to Expect during the MILED Trial?
Participants in the research study will:
- Attend 8 study visits over 2 years (some may be able to be completed remotely)
- Complete blood tests, a physical exam, and pulmonary function tests at visits
- Answer questions about breathing, fatigue, and quality of life
- Take one capsule each day and record doses and side effect in a diary
Study Drug:
The study is a double blind, placebo controlled trial. This means that study participants will have a 50/50 chance of getting either sirolimus or a placebo. 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 capsule every day and to record their medication 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 Carrie Keininger, 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. Carrie can be reached at 513-558-5602 or keinincl@ucmail.uc.edu. Additional information is also available on clincaltrials.gov. If you are eligible, you may participate in both the LAM protocol at the NIH and the MILED Trial.
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, contact info@thelamfoundation.org or 513-777-6889.