Clinical Protocol (NHLBI 06-H-0072): Atorvastatin as a disease-modifying agent in Stage II and Stage III Pulmonary Sarcoidosis: A randomized, double-blinded, placebo-controlled trial. ? ? Objectives:? The objective of this protocol is to conduct, in patients with pulmonary sarcoidosis who require prednisone treatment, a randomized, double-blind placebo-controlled, trial which aims to determine, as prednisone dose is tapered, if atorvastatin administration results in less steroid use and longer steroid-free intervals. ? The primary endpoint is the duration of the steroid-sparing period. Secondary clinical and physiological endpoints are intended to analyze possible anti-inflammatory and beneficial effects of the drugs. Since there is no gold standard outcome measure in sarcoidosis, four categories of secondary endpoints will be used to characterize the effects of the therapeutic agent on the clinical course of the disease: imaging (high resolution chest CT); quality of life assessments (SF-36 and SGRQ), anti-inflammatory effects (biomarkers and relapse rates), and functional effects (CPET, PFTs). Finally, we will study the utility of exhaled nitric oxide and carbon monoxide in monitoring disease activity.? ? Progress achieved: ? To date, over 544 subjects have been contacted, and approximately 500 have been interviewed using an IRB-approved screening questionnaire. Approximately 30 patients were eligible for further screening. Twenty four subjects have been enrolled, randomized, and started on study agent. ? ? Recruitment Data: ? ? Recruitment Parameters (n, subjects) ? ? Subject Contacts (544) ? Telephone Screening Questionnaires (500)? Clinical Exams/Screens Completed (91)? Accepted (27) ? Enrolled (24)? Subjects Eligible for Further Screening (30)? ? ? Human Tissues (Fluids)? Samples 2008 Total ? Blood (serum/plasma) 29 101? BAL 8 11
