High Doses of Inhaled Corticosteroids in Unstable Chronic Asthma: A Multicenter, Double-blind, Placebo-controlled Study

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Abstract
In a multicenter, randomized, double-blind study, inhaled beclomethasone dipropionate (BDP) 1,500 .mu.g/day was compared to placebo in 43 chronic asthmatic patients uncontrolled by inhaled salbutamol and oral theophylline. During the prestudy period, a test of maximal steroid reversibility with oral prednisolone 0.5 mg/kg/day for 14 days was performed. The therapeutic response was measured over an 8-wk period as the ability to maintain the clinical improvement and the optimal pulmonary function induced by prednisolone. During the study, severe asthma exacerbation occurred in one (5%) of the 21 patients who received BDP and in 15 (78%) of the 22 patients who received placebo (p < 0.001). In patients who received BDP, FEV1 and peak expiratory flow (PEF) remained above the optimal postprednisolone value, with a trend to improvement during the 8-wk study period. In patients who received placebo, FEV1 and PEF decreased and remained below the optimal value. We conclude that, in chronic asthma, inhaled BDP 1,500 .mu.g/day maintains the optimal pulmonary function in addition to the clinical benefit induced by a short course of oral corticosteroids.