Current Clinical Trials and Studies

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.

For a summary of all current trials and studies for LAM patients, CLICK HERE.

Ongoing Trials and Studies

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.

Study of the Disease Process of LAM - National Institutes of Health (NIH)plus

Joel Moss, MD, PhD
This study is designed to determine the disease processes involved at the level of cells and molecules to develop more effective therapies for LAM. Researchers intend to identify the proteins and genes that contribute to the process of lung destruction in affected individuals.

If you are interested in learning more, please contact:
Nora Quade, RN
Nurse Specialist, National Institutes of Health
(301)-496-3632 (o), (301)-661-1505(c)
nora.quade@nih.gov

Study site: Bethesda, MD
Visit https://go.usa.gov/xUuz9 for more details.

Helen Green Research Travel Grant

Patients who are participating at the protocol at the NIH may be eligible to apply for the Helen Green Research Travel Grant. To learn more about the grant and the guidelines, check out the Helen Green Research Travel Fund Guidelines Helen Green Research Travel Fund Guidelines. You can apply for the grant by clicking here.

If you have any questions regarding this travel grant, please contact Mary Sue Wentzel at mwentzel@thelamfoundation.org.

Tissue Donation - National Disease Research Interchange (NDRI)plus

National Disease Research Interchange (NDRI)
NDRI's Private Donor Program gives individuals and their families an opportunity to provide an invaluable resource for researchers working to discover and advance new treatments or cures. A variety of tissue samples from women with LAM, including lung, kidney, uterus, blood and chyle fluid are currently needed by LAM researchers. If you are having surgery and would be willing to make a tissue donation, or would like to learn more about the tissue donation process, please contact Patient Services at patientservices@thelamfoundation.org or (513) 777-6889.

Currently Enrolling Trials and Studies

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 Bloodplus

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:
Nora Quade, RN
Nurse Specialist, National Institutes of Health
(301)-496-3632 (o), (301)-661-1505(c)
nora.quade@nih.gov

Study site: Bethesda, MD
Visit https://go.usa.gov/xUuz9 for more details.

Bronchodilator Effects of Nebulized Versus Inhaled Albuterol In Subjects With Lymphangioleiomyomatosisplus

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:

Nora Quade, RN
Nurse Specialist, National Institutes of Health
(301)-496-3632 (o), (301)-661-1505(c)
nora.quade@nih.gov

Study site: Bethesda, MD
Visit https://go.usa.gov/xUuz9 for more details.

MILED - Multicenter Interventional LAM Early Diseaseplus

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.


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

If you are interested in learning more, please contact:
Sue McMahan
LAM Research Program Manager, University of Cincinnati College of Medicine
(513) 558-4376 (o)
susan.mcmahan@uc.edu

Study sites: Palo Alto, CA, Denver, CO, Atlanta, GA, Chicago, IL, Boston, MA, Cincinnati, OH, Philadelphia, PA, Nashville, TN, Seattle, WA.
Visit https://clinicaltrials.gov/ct2/show/NCT03150914?cond=Multicenter+Interventional+LAM+Early+Disease&rank=1 for more details.

Learn more about the MILED Trial at https://thelamfoundation.org/MILED.

MIDAS - Multi-Center International Durability and Safety of Sirolimus in LAMplus

New enrollment on hold

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.

If you are interested in learning more, please contact:
Sue McMahan
LAM Research Program Manager, University of Cincinnati College of Medicine
(513) 558-4376 (o)
susan.mcmahan@uc.edu

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.

RESULT - Resveratrol and Sirolimus in LAM Trialplus

Nishant Gupta, MD at University of Cincinnati Medical Center
Francis X. McCormack, MD at University of Cincinnati Medical Center
Marina K. Holz, PhD at Yeshiva University

This is an open-label, phase II study of escalating doses of resveratrol in patients on a stable dose of sirolimus. Twenty-five patients will be enrolled. The primary endpoint will be to determine if there is a change in serum VEGF-D after 24 weeks of combined resveratrol and sirolimus as compared to the VEGF-D level in sirolimus alone. Secondary endpoints include PFTs, QOL assessments, safety and adverse effect profiles. Key inclusion criterion: LAM patients on sirolimus for at least 20 weeks, with stabilization of VEGF-D levels post sirolimus as tested by at least 2 lab draws at least 12 weeks apart. Total trial duration is 3 years. CLICK HERE for more information about the study.

If you are interested in learning more, please contact:
Becky Ingledue
(513) 558-0027(o)
Rebecca.ingledue@uc.edu

Study site: Cincinnati, OH
Visit https://clinicaltrials.gov/ct2/show/NCT03253913?cond=Resveratrol+and+Sirolimus+in+LAM+Trial&rank=1 for more details.


If you are a researcher looking for support from The LAM Foundation to promote your trial, please contact Mary Sue Wentzel at mwentzel@thelamfoundation.org.