Study Comparing Two Prednisolone Tapering Methods in Adults with Stable Sarcoidosis

What this Trial Is About

Sarcoidosis is an inflammatory disease that commonly affects the lungs but can involve many parts of the body. Its cause is unknown, and while some patients may not need treatment, others require long-term therapy. This research evaluates two different ways to reduce corticosteroid medication, specifically prednisolone, to find the best approach for patients with stable sarcoidosis who are currently taking daily doses between 5mg and 10mg. The study is randomized and aims to understand how many patients can reduce their steroid dose by at least half and to monitor related effects. Participants will be randomly assigned to one of two prednisolone tapering plans a standard taper or a faster taper. Both plans start by reducing the dose by 2.5mg every four weeks until reaching 5mg per day. Then, the standard taper reduces by 1mg every six weeks until 3mg, while the fast taper reduces by 1mg every two weeks until 3mg. At 3mg, a blood test measuring serum cortisol is done, and if levels are above 25nmolL, tapering continues at a slower pace. The fast taper group receives phone support every two weeks to assist with the regimen. Some participants will also undergo tests to assess body composition and muscle strength. Throughout the study, participants attend a baseline in-person visit to complete questionnaires about quality of life and fatigue, with follow-up visits mainly conducted by phone when reaching certain dose milestones 5mg and 3mg. Blood tests for cortisol are done two weeks after reaching 3mg. After completing the taper or reaching the lowest dose possible, a final phone visit occurs six weeks later with additional assessments for some participants. One year after randomization, researchers review medical records to check current prednisolone doses. The main outcome measured is the proportion of patients achieving at least 50% reduction in prednisolone dose, along with tracking quality of life, steroid withdrawal symptoms, and body composition changes.

Corticosteroid Tapering in Sarcoidosis