Protocol Number: 08-H-0177
Women 18 years of age or older with lymphangioleiomyomatosis (LAM) may be eligible for this study. Participants are randomly assigned to receive either sirolimus or placebo. Both groups take two tablets every day, and both groups may have the number of tablets adjusted based on blood tests. In addition to taking a study drug or placebo, patients have study visits at enrollment, 3 weeks after enrollment, then once every 3 months in the first year and once every 6 months in the second year. The visits include the following: Physical examination, blood tests and questionnaires relating to the patient's lung health and general health every visit. Spirometry test to measure lung function every 3 months the first year and every 6 months the second year. For this test, the subject inhales deeply and then blows through a mouthpiece into a tube as fast as she can until the air is exhaled. The test is repeated after the subject takes a bronchodilator medicine (salbutamol/albuterol). At six of the visits, additional pulmonary function tests are done to measure lung volumes (how much air is in the chest) and how well oxygen passes from the air sacs of the lungs into the blood. These tests require the subject to take additional breaths in and out of the mouthpiece. At six of the visits, subjects perform a 6-minute walk test on room air or on oxygen in order to test exercise tolerance. The subject walks for 6 minutes while oxygen saturation, heart rate, and the distance walked are measured. Chest x-rays: Chest x-rays are done at the first and last visits to compare lung damage from disease. Volumetric chest CT scan: This scan is done at three visits to measure the amount of normal tissue in the chest and the portion of the lungs involved with cysts. Urine tests for pregnancy at each visit and for kidney function. Drug diaries: Subjects keep a record of all the medicines, including the study drug, that they take while on the study.
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/30/2009
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