Oral prednisolone followed by inhaled budesonide in newly diagnosed pulmonary sarcoidosis - A double-blind, placebo-controlled multicenter study

Study objective: To evaluate the efficacy of oral prednisolone, followed by inhaled budesonide, in patients with newly diagnosed (< 3 months) stage I and stage IT pulmonary sarcoidosis. Design: Double-blind, placebo-controlled, parallel-group, multicenter study . Setting: Twenty pulmonary medicine departments in Finland. Patients: One hundred eighty-nine adult patients were randomized to treatme nt. Patients with erythema nodosum or stage IV sarcoidosis (pulmonary fibro sis), and patients requiring immediate treatment with oral corticosteroids for extrapulmonary lesions or chronic illnesses were excluded. Treatment: The patients received either oral prednisolone for 3 months (20 mg/d for 8 weeks, 15 mg/d for 2 weeks, and 10 mg/d for 2 weeks) followed by inhaled budesonide (Pulmicort Turbuhaler; Astra Draco; Lund, Sweden) for 1 5 months at 800 mu g bid, or placebo tablets followed by placebo inhaler th erapy. Measurements: Chest radiographs, lung volumes (FVC), diffusing capacity of the lung for carbon monoxide (DLCO), serum angiotensin-converting enzyme (S ACE), and beta(2)-microglobulin at 3-month intervals. Results: After 3 months of treatment, radiographic improvements were seen i n the active-treatment group when compared to the placebo-treatment group. At 6 months, the difference was still statistically significant. Later, no differences were found. In patients with initial stage I lesions, neither t he FVC nor the DLCO (the percent predicted mean values) changed during the study, as they were normal from the beginning. In patients with initial sta ge II disease, the difference in the FVC mean values between the groups als o remained unchanged throughout the study. In stage II patients treated for 18 months, but not earlier, the difference in DLCO became statistically si gnificant; the largest differences were seen in patients with initial FVC v alues < 80% of predicted and DLCO values < 75% of predicted. The decrease i n SAGE in the active-treated stage II patients was significantly larger tha n in the placebo-treated patients. No difference was observed in adverse ev ents between the active-treated patients and the placebo-treated patients. Conclusion: Treatment is not required for patients with stage I disease. An initial treatment with prednisolone followed by long-term inhalation of bu desonide is more effective than placebo in patients with stage II disease. Sequential oral and inhaled corticosteroid therapy may be an alternative tr eatment regimen for stage II sarcoidosis patients, rather than long-term or al corticosteroid therapy alone.