Corticosteroids are presently the drug of choice for the treatment of pulmonary sarcoidosis.
However, corticosteroids are associated with many significant side effects. For this reason,
it would be beneficial to find an alternative agent to corticosteroids for the treatment of
pulmonary sarcoidosis. This study is an open label trial of mycophenolate for new onset
pulmonary sarcoidosis. Patients are candidates for this study if they have biopsy proven
pulmonary sarcoidosis and a vital capacity or FEV1 less than 80% of predicted. Patients must
undergo bronchoscopy where not only is the diagnosis of pulmonary sarcoidosis required, but
in addition, cells are obtained from bronchoalveolar lavage. If the patients are diagnosed
with pulmonary sarcoidosis, they are placed on an initial dose of 500mg BID of mycophenolate
for 1 week. If their blood counts are not affected on this dose and they have no significant
symptoms that are thought to be drug related, then their dose is escalated to 1g BID for the
remaining 9 weeks of the study (the total study drug therapy time is 10 weeks). The patients
are followed with multiple study visits. At these visits blood tests are drawn to make sure
that there are no significant side effects from mycophenolate. In addition, the patients have
a history and physical performed to evaluate the clinical state of their sarcoidosis and to
detect mycophenolate side effects. On completion of 10 weeks of mycophenolate therapy, the
patients undergo a second bronchoscopy with bronchoalveolar lavage to obtain cells for
analysis. The patients are evaluated with spirometry, measurements of shortness of breath
(dyspnea), and a quality of life scale (SF36) at serial visits during their study. The
primary endpoint of the study is improved, unchanged or worse FVC. It is hoped that this
pilot study will suggest that mycophenolate is a reasonable treatment option for new onset
pulmonary sarcoidosis.