INHALED BUDESONIDE THERAPY FOR PATIENTS WITH STABLE COPD

A significant minority of patients with COPD have favorable response to corticosteroid treatment. In addition, the benefit of corticosteroid treatment may be outweighed by the side effects. Long-term administration of inhaled steroids is a safe means of treatment. We hypothesized that treatment with high-dose inhaled budesonide would improve clinical symptoms and pulmonary function in subjects with COPD, and that the response to inhaled beta(2)-agonist will serve to individualize steroid responders. We compared a 6-week course of 800 mu g/d inhaled budesonide with placebo, separated by 4 weeks when no medication was taken, in a double-blind crossover trial, in 8 patients responding to inhaled beta(2)-agonist, and in 22 nonresponders with stable COPD. In six of eight ''responders to beta(2)-agonist,'' there was a significant improvement in the FEV(1) (defined as greater than or equal to 20%) following inhaled budesonide, as compared with placebo. In the 22 ''nonresponders to beta(2)-agonist,'' there was no significant improvement in the mean FEV(1) (1.41+/-0.1 L before, and 1.61+/-0.1 L after treatment) with inhaled budesonide or placebo. Over the 6-week course of treatment by either budesonide or placebo, the nonresponders reported similar beta(2)-agonist consumption (4.8+/-0.2 and 5.0+/-0.1 puffs per patient per day, respectively). However, there was a significant difference between the two periods of treatment in the responders as for the mean daily number of beta(2)-agonist inhalations (2.4+/-0.1 in the budesonide period as compared with 5.3+/-0.1 in the placebo period; p<0.005). We conclude that treatment with inhaled steroids improved spirometry data and inhaled beta(2)-agonist consumption in about 25% of patients with stable COPD, and this rate is increased to about 75% in patients who respond to beta(2)-agonist inhalation.