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Protocol Number: 06-H-0072 
Patients with stage II or III pulmonary sarcoidosis between 18 and 70 years of age who require prednisone may be eligible for this study. Candidates are screened with the tests and procedures described below. Participants are randomly assigned to one of two treatment groups: one group takes atorvastatin; the other takes a placebo (a look-alike pill that has no active ingredient to fight sarcoidosis). Both groups take the pills by mouth once a day for 12 months. When treatment begins, participants begin to have their prednisone dosage tapered (reduced). The tapering is done over 8 weeks until the dose is reduced by 90 percent. Patients are evaluated periodically to determine if the two groups differ in how long they can remain on the reduced dose of prednisone without having their symptoms recur, requiring an increase in the prednisone dose. A full battery of tests is done at the initial screening visit and at the 26- and 52-week follow-up visits, requiring hospitalization for 3-5 days. Additional interim outpatient assessments are done at 6, 12, 18 and 36 weeks. The full battery of tests at the initial screening and the 26- and 52-week visits includes the following: -Medical history, physical examination, blood and urine tests, assessment of disease severity and activity. -Questionnaires. -Chest x-ray (CXR) and computed tomography (CT) scan. -Abdominal ultrasound. -Six-minute walk test (6MWT): test to see how far the subject can walk in 6 minutes. -Exercise testing and blood gases: Patients exercise on a stationary bicycle or treadmill while their heart and lung function are monitored. During the test, arterial blood gases are measured to determine the amount of oxygen and carbon dioxide in the blood. -Pulmonary function tests (PFT): Patients are asked to breathe deeply and, occasionally, to hold their breath. They may be given a medicine called albuterol that dilates the airways. -Maximum incremental ventilatory performance test (MIVP): Patients breathe normally through a mouth piece. The test system makes it increasingly difficult to inhale. Patients stop when they feel fatigued. -Exhaled nitric oxide and carbon monoxide (Exhaled NO and CO): Patients breathe out into a tube that collects exhaled air (gases). -Bronchoscopy and lavage: The patient's mouth and throat are numbed with lidocaine; a sedative and morphine-like drug are given for comfort. A tube is passed through the nose or mouth into the lung airways to examine the airways. Saline (salt water) is then injected through the bronchoscope into the air passage, and a sample of fluid is withdrawn for microscopic examination. Patients who do not have confirmation of their lung disease may also undergo biopsy at the time of lavage. For the biopsy, a small piece of tissue is extracted from the wall of the breathing tubes (bronchi) or the lymph nodes. Interim testing at 6, 12, 18 and 36 weeks includes PFT, MIVP, Exhaled NO and CO, CXR, questionnaire, blood tests, and 6MWT. Six months after completing the study, participants fill out a questionnaire.
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 09/16/2008