Part of the mission of The LAM Foundation is to support promising research and provide information about ongoing LAM clinical trials to patients. LAM researchers need patient participation to meet their research goals. Please review the open protocols below to learn more about how you can participate in LAM clinical research trials.
The following trials and studies are ongoing and are open to most women with LAM. Please see the specific protocols below to determine if you are eligible to participate.
Below you will find LAM clinical trials and studies that are currently enrolling. Please be sure to check the details of each open protocol to find out if you are eligible to participate. We encourage anyone who is considering enrollment in a clinical trial to contact the trial coordinator. They are very interested in talking to LAM patients and will provide detailed information so that you can decide what is best for you.
Discovery of Sirolimus Sensitive Biomarkers in Blood plus
Joel Moss, MD, PhD, National Institutes of Health
This study is an observational study designed to determine if blood and urine markers after 1 dose and again after 3 months can be used to evaluate the correct dose of sirolimus for people with LAM. Women ages 18-90 with LAM whose doctors have decided they should start taking a 2 mg dose of sirolimus to treat it and who are able to travel to NIH are eligible to participate.
If you are interested in learning more, please contact:
Tat'Yana Worthy, RN MSN
Research Nurse Specialist, National Institutes of Health
(301)-496-3632 (o)
Tat'Yana Worthy, RN MSN
Study site: Bethesda, MD
Visit https://go.usa.gov/xUuz9 for more details.
Bronchodilator Effects of Nebulized Versus Inhaled Albuterol In Subjects With Lymphangioleiomyomatosis plus
Angelo M Taveira-DaSilva, MD, National Heart, Lung, and Blood Institute (NHLBI)
LAM is a progressive lung disease that usually strikes women during their childbearing years, usually between the onset of puberty and menopause. Doctors at the National Institutes of Health (NIH) are conducting a research study to compare two methods, albuterol (study drug) given in metered dose inhaler and sprayer, and to determine which of these two methods best improves lung function in women with LAM.
About the Study
- Participants will have a physical exam and medical history
- 3-day overnight stay at our hospital (NIH Clinical Center)
- Participants will take albuterol using a hand held inhaler and nebulizer during their hospital stay
Who can participate?
- Adult women who have impaired lung function because of LAM
AND
- With no known allergy to albuterol
If you are interested in learning more, please contact:
Tat'Yana Worthy, RN MSN
Research Nurse Specialist, National Institutes of Health
(301)-496-3632 (o)
Tat'Yana Worthy, RN MSN
Study site: Bethesda, MD
Visit https://go.usa.gov/xUuz9 for more details.
MILED - Multicenter Interventional LAM Early Disease plus
Francis X. McCormack, MD at University of Cincinnati Medical Center
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, similar to the manner in which we treat diabetes and high blood pressure early to prevent future heart and kidney complications.
Learn more about the MILED Trial at https://thelamfoundation.org/MILED.
You may be eligible if you:
- Are an adult woman with LAM
- Have an FEV1 greater than 70% predicted
- Are not currently taking sirolimus
During the study, participants 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
- Take one pill every day (1 mg sirolimus or a sugar pill) throughout the study
- Record their pill taking and any side effects in an electronic diary
Participants will receive:
- Physical exams, pulmonary function tests, a chest x-ray, and laboratory tests free of charge
- Study drug (either 1 mg sirolimus or placebo) throughout the study
- Reimbursement for travel expenses to attend each study visit
To get more information or to see if you may be eligible, please contact Susan McMahan Sellers, BSN, RN, or Carrie L. Keininger, BSN, RN. We can answer your questions, provide additional information, and refer you to the closest MILED study site.
Susan’s contact information is susan.mcmahan@uc.edu | 513-558-4376
Carrie's contact information is keinincl@ucmail.uc.edu | 513-558-5602
Sites that are welcoming new participants are located in Atlanta, Chicago, Cincinnati, Seattle, and New York City.
MIDAS - Multi-Center International Durability and Safety of Sirolimus in LAM plus
Francis X. McCormack, MD at University of Cincinnati
The MIDAS trial continues to recruit patients eager to contribute to LAM research. This study aims to follow patients with LAM over at least two years by collecting information from their regular clinic visits with their LAM clinic provider. Almost all LAM patients can participate and adult women with TSC are eligible, whether lung cysts are present are not. There are currently 20 participating LAM clinics and over 400 patients currently enrolled.
To get more information or to see if you may be eligible, please contact Susan McMahan Sellers, BSN, RN, or Carrie L. Keininger, BSN, RN. We can answer your questions, provide additional information, and refer you to the closest study site.
Susan’s contact information is susan.mcmahan@uc.edu | 513-558-4376
Carrie's contact information is keinincl@ucmail.uc.edu | 513-558-5602
Study sites: Cleveland Clinic Foundation, Emory University, Harvard/BWH, Loyola University Chicago, Mayo Clinic, Jacksonville and Rochester MN, MUSC, National Jewish Health, OHSU, Stanford University, Swedish, University of Cincinnati, University of Michigan, University of Pennsylvania, University of Rochester, University of Utah, University of Texas Health Center, University Texas SW, Vanderbilt University, and Washington University.
Visit https://clinicaltrials.gov/ct2/show/NCT02432560?cond=MIDAS&rank=10 for more details.