INHALED BUDESONIDE IN PULMONARY SARCOIDOSIS - A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

In a double-blind, placebo-controlled study, we assessed the efficacy of inhaled budesonide on the course of newly diagnosed pulmonary sarco idosis and whether budesonide treatment could postpone oral corticoste roid treatment. We evaluated: 1) symptoms; 2) chest radiography; 3) an giotensin-converting enzyme (ACE) in serum; and 4) lung function. Pati ents with histologically confirmed pulmonary sarcoidosis with chest ra diographic stages I, II or III, and with an abnormal lung function (in spiratory vital capacity (IVC) <79% of predicted or transfer factor of the lungs for carbon monoxide (TL,CO) <77% pred) were included, Patie nts with radiographic stage II or III but with normal lung function we re included when more than 20% of the total cell population in broncho alveolar lavage fluid (BALF) was lymphocytes. Forty seven patients rec eived placebo or budesonide (1.2 mg) once daily via a Nebuhaler for 6 months, followed by 6 months without treatment, Based on predetermined criteria, 11 patients were excluded during the blind treatment period Keywords: Budesonide pulmonary sarcoidosis as they needed oral predni sone: seven (28%) patients in the placebo group (n=25) and four (18%) patients in the budesonide group (n=22). Patient's Global Clinical Imp ression (GCI) score showed a significant difference in favour of budes onide, IVC showed a significant difference of 7.9% predicted between t he two groups during the active treatment period, This difference pers isted during follow-up, when the difference was 9.4% pred, TL,CO remai ned nearly unchanged over time, with no difference between the groups, Improvements in chest radiographic appearance and changes in serum AC E were similar for the two groups. We conclude that, in patients with pulmonary sarcoidosis, inhaled budesonide results in better subjective symptom scores and a significant improvement of IVC, These findings a re in support of a role for inhalation of corticosteroids in pulmonary sarcoidosis, as they may reduce deterioration and postpone the need f or systemic corticosteroids.