The SOS Trial: Safety of Simvastatin in Patients with Pulmonary Lymphangioleiomyomatosis and with Tuberous Sclerosis Complex
Brief Description Of Study
This 4-month trial is a pilot safety study of simvastatin in patients with sporadic pulmonary LAM or LAM associated with Tuberous Sclerosis.
Detailed Study Description
The objective of the trial is to determine the safety of simvastatin in combination with either sirolimus or everolimus in patients with LAM. To qualify for the trial, women with LAM must be 18 years of age or older, be able to give informed consent and have abnormal lung function (specifically, a postbronchodilator, forced expiratory volume in one second (FEV1) of 70% of predicted or less). The SOS Trial will require six visits over 5 months during which pulmonary function studies, blood tests, questionnaires and x-rays are administered.