Efficacy and Safety of Two Glucocorticoid Regimens in the Treatment of Sarcoidosis — SARCORT  

Sarcoidosis Clinical Trial

Official title: Efficacy and Safety of Two Glucocorticoid Regimens in the Treatment of Sarcoidosis: a Randomized Controlled Trial

Status Completed

Clinical Trial Summary

For pulmonary sarcoidosis, the initial dose recommended by the joint statement of the American Thoracic Society (ATS), European Respiratory Society (ERS), and The World Association of Sarcoidosis and Other Granulomatous Disorders (WASOG) is 20-40 mg per day.5 The exact dose and duration of treatment for sarcoidosis are unknown.4 We hypothesize that a higher dose of 40 mg per day as compared to a 20 mg/day dose of prednisone will be more effective in preventing post-treatment relapse by effective initial suppression of the granulomatous inflammation and reduction of the disease load. In this study, we compare the efficacy and safety of medium dose (40 mg/day prednisone) and low dose (20 mg/day prednisone) glucocorticoids in the treatment of acute sarcoidosis.

Clinical Trial Description

Glucocorticoids are the cornerstone of treatment of sarcoidosis and are used as the first-line agents in patients requiring immunosuppressive therapy.4 The optimal dose and duration of glucocorticoids is an unresolved issue. For pulmonary sarcoidosis, the initial dose recommended by the joint statement of the ATS/ERS/WASOG is 20-40 mg per day.5 The duration of treatment recommended is at least one year. However, mild disease of recent onset may respond to a shorter duration of treatment. Further, as most of the toxic effects of glucocorticoids are cumulative, the dose and duration of steroids need to be kept to a minimum to balance the benefit and risks of treatment. Two large studies performed about two decades ago used an initial dose of 30 mg and 20 mg respectively for treating acute sarcoidosis. While the British Thoracic Society employed steroid treatment (initial dose 30 mg/day) for one year, in the Finnish study, oral glucocorticoids (initial dose 20 mg/day) were administered for three months and were followed by inhaled budesonide.3,6 In a recent Delphi study of experts, 37% and 20% of the experts used an initial prednisone equivalent dose of 40 mg per day and 20 mg per day regardless of weight, respectively.7 About 23% used doses of 20 mg, 30 mg, or 40 mg per day depending on weight. However, consensus was reached that a dose higher than 40 mg per day is not required. Apart from the initial response to glucocorticoids in symptoms and lung function, the rate of relapse after cessation of treatment is an important outcome in the management of sarcoidosis. The exact dose and duration of treatment for sarcoidosis are unknown.4 We hypothesize that a higher dose of 40 mg per day as compared to a 20 mg/day dose of prednisone will be more effective in preventing post-treatment relapse by effective initial suppression of the granulomatous inflammation and reduction of the disease load. In this study, we compare the efficacy and safety of medium dose (40 mg/day prednisone) and low dose (20 mg/day prednisone) glucocorticoids in the treatment of acute sarcoidosis. ;

Related Conditions & MeSH terms

• Sarcoidosis

• NCT number: NCT03265405
• Study type: Interventional
• Source: Postgraduate Institute of Medical Education and Research
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 2017
• Completion date: October 31, 2022