Q&A: The MILED Trial

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Published 9/25/2018

“As a LAM patient, one of the most important things you can do is become informed about the indispensable value of clinical trials. These trials are the only way we will get answers. I encourage everyone to enroll—it’s so important to our ability to make progress.”
Dr. Frank McCormack, Scientific Director, The LAM Foundation

The MILED Trial is a currently enrolling study led by Dr. Frank McCormack, Scientific Director of The LAM Foundation. The trial seeks to answer an important clinical question about early treatment of LAM. That question is: “Does early treatment of mild LAM symptoms with low dose sirolimus stop progression of disease and cyst formation in the lungs?” The answer to this question will benefit patients with LAM all around the world.

Here, we answer your own questions about the MILED Trial. 

Q: Why is this trial important? 

The MILED Trial seeks to answer an important clinical question about early treatment of LAM. That question is: “Does early treatment of mild LAM symptoms with low dose sirolimus stop progression of disease and cyst formation in the lungs?” The answer to this question will benefit patients with LAM all around the world. 

Q: What can I do to help? 

Most importantly, we need eligible LAM patients to participate in this study—but that isn’t the only way to make an impact. Just by learning about the MILED Trial and spreading the word, you can help us change everything for women with LAM. Talk to your fellow Lammies about MILED. Get in touch with the researchers. Ask any questions you may have. Because there are only a small number of patients who meet the criteria to join this study, we need everyone’s help to keep this groundbreaking research moving forward. 

Q: Who can participate in the study?  

Participants must be women diagnosed with LAM, and:

  • Be 18 years of age or older

  • Have normal lung function (FEV1 >70%)

  • Not currently be taking sirolimus or everolimus 

If this sounds like you or someone you know, please contact Susan McMahan at susan.mcmahan@uc.edu or call 513-558-4376 to learn more. 

Q: Where will I need to travel, and how much will it cost me?  

There are currently study sites in the following locations: 

  • Brigham and Women’s – Boston, MA

  • Cleveland Clinic – Cleveland, OH

  • Emory University – Atlanta, GA  

  • Loyola University – Chicago, IL

  • National Jewish Health – Denver, CO

  • Stanford University Medical Center – Palo Alto, CA

  • Swedish Medical Center – Seattle, WA

  • University of Cincinnati – Cincinnati, OH

  • University of Pennsylvania  Philadelphia, PA

  • Vanderbilt University – Nashville, TN

  • Washington University – St. Louis, MO

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 Anne McKenna at amckenna@thelamfoundation.org or 513-777-6889. 

Q: How often will I need to visit the study site? 

You will be required to visit your nearest study site every 4 months. Over the 2-year duration of the study, this will make 7 visits total. The initial and final visits may be conducted over 2 days to complete all necessary study activities, depending on your needs as a patient and the clinical resources of the site. 

Q: What will happen at the study site? 

During each study visit, you will have:

  • Blood tests

  • A physical examination

  • Pulmonary function tests

  • Questionnaires about breathing, fatigue, and quality of life 

Q: What will I have to do at home? 

After your first study visit, you will take one pill every day. You will have a fifty-fifty chance of getting 1mg/day of sirolimus or a placebo. You will not know what you have received, and neither will your study doctor until the study is complete. You will need to keep track of your dosages and any side effects that you may experience. You will also be asked to perform spirometry tests each week. These tests will measure the airflow into and out of your lungs. You will be able to do this at home with the GoSpiro Home Spirometer. This device will be provided to you at no cost and will be returned after the study is complete. 

Q: Can I keep seeing my regular doctor? 

You may continue to see your regular doctor, but during the course of the study, you will be expected to stay in contact with the study coordinator and study doctor. You will need to inform them of any emergency room visits, hospitalizations, or health changes during this time. 

Q: What if I decide not to complete the study? 

We would like you to continue full participation until your planned study visits are completed. However, you can withdraw at any time. If you join the study and then decide to stop participating, we would recommend talking with your study doctor and regular doctor before withdrawing so that there is a good plan in place for post-study care. 

Q: I want to get involved—what do I do now? 

Please contact one of the following LAM Clinics below, or reach out to Susan McMahan at susan.mcmahan@uc.edu or 513-558-4376. 

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