NO EFFECT OF HIGH-DOSE INHALED STEROIDS IN PULMONARY SARCOIDOSIS - A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

Objective. To evaluate whether inhaled steroids in high doses might be of therapeutic value in pulmonary sarcoidosis. Design. Randomized, do uble blind and placebo controlled parallel study. Setting. The out-pat ient clinic of the Department of Pulmonary Medicine, Gentofte Hospital , Copenhagen, Denmark. Subjects. Twenty-one untreated patients (17 mal es, 4 females, median age 33 years, range 21-65) and eight patients tr eated with systemic prednisolone. All patients had biopsy proven pulmo nary sarcoidosis radiological stage I-III. Interventions. Treatment wi th either inhaled budesonide 1.2 mg day(-1)-2.0 mg day(-1) (n = 9) or placebo (n = 12) for 12 months. Main outcome measures. Clinical (cough , chest pain, dyspnoea) and paraclinical variables (chest X-ray, galli um scintigraphy, pulmonary function tests, and biochemical markers of disease activity: blood leukocytes, lymphocytes, serum (S-) angiotensi n converting enzyme (ACE), S-1,25-OH-cholecalciferol, plasma (P-) calc ium, P-immunoglobulins) were recorded before treatment, every three mo nths during treatment, and 6 months after treatment had been discontin ued. Results. There were no significant differences between the record ed variables in the budesonide and placebo groups. In general, a regre ssion of disease activity was observed in both groups. Two patients in the treatment group, treated with 2.0 mg budesonide/day, and two in t he placebo group had progression in disease and were put on systemic s teroids. Conclusion. Inhaled budesonide in doses of 1.2-2.0 mg day(-1) had no recognizable therapeutic effect on pulmonary sarcoidosis.