The Multicenter Interventional Lymphangioleiomyomatosis Early Disease (MILED) Trial Is Open to Enrollment
The MILED Trial is a research study led by Dr. McCormack at the University of Cincinnati. The study is very close to opening additional sites with a goal of opening all sites by the end of 2017. The study will enroll 60 eligible LAM patients across the country.
Women who participate will be helping LAM researchers answer a very important clinical question about early treatment of LAM. That question is: “Should we use low dose sirolimus early in LAM to stop progression of disease and cyst formation in the lungs by this type of therapy? The answer to this question will benefit patients with LAM all around the world.
Potential participants are adult patients with a LAM diagnosis, post-bronchodilator FEV1 of > 70%, DLCO above 60% predicted, resting room air saturation of 90% or greater (at sea level), and not currently taking sirolimus.
What to expect during MILED
Participants in the research study will attend 7 study visits over approximately 2 years (about one visit every 4 months), complete blood tests, a physical exam, and pulmonary function tests at visits and complete questionnaires about breathing, fatigue and quality of life.
The study is a double blind, placebo controlled trial. What this means is that study participants will have a fifty-fifty 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 (sirolimus or 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.
Reasonable travel expenses to enable participants to get to and from study visits will be supplied by The LAM Foundation. In order to minimize travel, we are planning to open sites in Atlanta, Boston, Denver, Chicago, Cincinnati, Cleveland, Nashville, Philadelphia, Seattle and Stanford. For inquiries about travel expense support, please contact Anne McKenna, Community Manager at the LAM Foundation to request more detailed information. Anne can be reached at firstname.lastname@example.org or at 513-777-6889.
For additional study information or to be connected with the study team at your local LAM clinic, please contact Susan McMahan at email@example.com or 513-558-4376.
The safety of LAM patients is paramount to the caregivers conducting this study. The study team will plan to stay in close communication with study participants throughout the trial. A description of this clinical trial will be available on www.clinicaltrials.gov, as required by U.S. Law. ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.