Sandostatin therapy in sarcoidosis

Design:nonrandomized, open label, proof of principal investigator initiated trial.



Subjects:patients with chronic, symptomatic and stable sarcoidosis that show inflammatory activity on somatostatin receptor scan and previously received treatment with corticosteroids.



Study medication:Monthly injections with sandostatin for six months.



Objective: To evaluate efficacy of sandostatin in a subset of patients that are refractory/intolerant to corticosteroid therapy.



Primary endpoint:change in uptake on somatostatin receptor scan.



Secondary enpoints: bloodtests, quality of life score, pulmonary function and skin evaluation.

Sarcoidosis (SA) is a rare systemic disease that is characterized by the formation of granulomas. It can affect any organ in the body. Somatostatin is a peptide hormone that regulates neuroendocrine processes but it also is an intersystem signalling molecule on the immune system and is implicated in the pathogenesis of SA. Sandostatin (SST), octreotide is the stable and synthetic analogue of the natural somatostatin. Octreotide has an inhibitory effect of the immune system. Affected locations in SA show octreotide uptake on SRS. As corticosteroids, with all the additional disadvantages, are first-line treatment in sarcoidosis, SST is studied as an alternative treatment for SA.

Duration of intervention is six months. Primary endpoint (somatostatin receptor scan) after nine months after initiation therapy. Total folluw up is 12 months.

Patients will receive 20 mg of sandostatin injection intramuscular IM every month for six months.