The response to inhaled and oral steroids in patients with stable chronic obstructive pulmonary disease

Background. A significant minority of patients with COPD have favourable 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. However, only a few studies have addressed the role of inhaled steroids in patients with COPD, with conflicting results. Methods. Forty-four patients with stable COPD were defined as 'responders to bronchodilators' (increase in FEV₁ ≥ 20% following administration of β₂-agonist) (group A), and 124 as 'non- responders to bronchodilators' (group B). All patients were randomized to receive a 6-week course of either a daily dose of 800 μg of inhaled budesonide or placebo, separated by 4 weeks when no medication was taken; were randomized again to receive a 6-week course of either 1600 μg day^-1 of inhaled budesonide, or 800 μg day^-1 of inhaled budesonide plus placebo; and were randomized once again to receive a 6-week course of either 40 mg day^-1 of prednisone or placebo. All stages were performed in a double- blind cross-over design. Results. Following administration of 800 μg day^{- 1} of inhaled budesonide, there was an increase in the mean FEV₁ from 1.40 ± 0.20 to 1.92 ± 0.22 L (P < 0.001) and a significant decrease in inhaled β₂ agonist consumption in group A. These changes remained almost stable during the increased dose of inhaled budesonide or during prednisone treatment. The mean FEV₁ did not change during the placebo period, or in group B in either treatments. Conclusions. Treatment with inhaled steroids improved spirometry data and inhaled β₂-agonist consumption in about one- quarter of patients with stable COPD, and this rate increased to about three- quarters in patients who responded to β₂-agonist inhalation. There was no additional benefit in using a higher dose of inhaled budesonide or prednisone.