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Oral Prednisolone Followed by Inhaled Budesonide in Newly Diagnosed Pulmonary Sarcoidosis^*

A Double-Blind, Placebo-Controlled Multicenter Study

Anne Pietinalho, MD; Pentti Tukiainen, MD, PhD, FCCP; Tari Haahtela, MD, PhD; Tore Persson, PhD; Olof Selroos, MD, PhD, FCCP and the Finnish Pulmonary Sarcoidosis Study Group^,§

^* From the Meltola Hospital (Drs. Pietinalho and Selroos), Karjaa, Finland; the Departments of Pulmonary Medicine (Dr. Tukiainen), and Allergic Diseases (Dr. Haahtela), University Central Hospital, Helsinki, Finland; and Astra Draco AB (Dr. Persson), Lund, Sweden.

Correspondence to: Olof Selroos, MD, FCCP, Solvegatan 3A, S-233 62 Lund, Sweden; e-mail: olof.selroos{at}draco.se.astra.com

Study objective: To evaluate the efficacy of oral prednisolone, followed by inhaled budesonide, in patients with newly diagnosed (< 3 months) stage I and stage II 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 treatment. Patients with erythema nodosum or stage IV sarcoidosis (pulmonary fibrosis), 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 15 months at 800 µg bid, or placebo tablets followed by placebo inhaler therapy.

Measurements: Chest radiographs, lung volumes (FVC), diffusing capacity of the lung for carbon monoxide (DLCO), serum angiotensin-converting enzyme (SACE), and ß₂-microglobulin at 3-month intervals.

Results: After 3 months of treatment, radiographic improvements were seen in 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 the FVC nor the DLCO (the percent predicted mean values) changed during the study, as they were normal from the beginning. In patients with initial stage II disease, the difference in the FVC mean values between the groups also remained unchanged throughout the study. In stage II patients treated for 18 months, but not earlier, the difference in DLCO became statistically significant; the largest differences were seen in patients with initial FVC values < 80% of predicted and DLCO values < 75% of predicted. The decrease in SACE in the active-treated stage II patients was significantly larger than in the placebo-treated patients. No difference was observed in adverse events 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 budesonide is more effective than placebo in patients with stage II disease. Sequential oral and inhaled corticosteroid therapy may be an alternative treatment regimen for stage II sarcoidosis patients, rather than long-term oral corticosteroid therapy alone.

Key Words: angiotensin-converting enzyme • budesonide • chest radiograph • glucocorticosteroids • inhalation • lung volumes • prednisolone • sarcoidosis

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