Onset of action of formoterol/budesonide in single inhaler vs. formoterol in patients with COPD

Formoterol is a beta(2)-agonist bronchodilator that combines a fast onset of action with a long duration of broncholytic effect. An increasing documentation is showing that the combination of a long acting beta(2)-adrenoceptor agonist bronchodilator and an inhaled corticosteroid targets the airways obstruction in patients with COPD. In this study, we have explored whether the acute addition of an inhaled corticosteroid influences the fast bronchodilator response to formoterol. A total of 20 patients with stable COPD were randomized. Single doses of formoterol/budesonide 2 X (4.5/160) mug or formoterol 2 X 4.5 mug were given via Turbuhaler. Serial measurements of FEV1 were performed over 60 min. Formoterol/budesonide elicited a significantly larger mean FEV1-AUC(0-15 min) than formoterol alone. Also the change in FEV1 15 min after inhalation of formoterol/budesonide combination (0.197 1; 95% CI: to 0.142-0.252) was greater than that induced by formoterol alone (0.147 1; 95% Cl: to 0.092-0.201). The mean increases in FEV1 were always higher after budesonide/formoterol than formoterol alone, although both treatments induced a significant improvement over baseline at each explored time point. Even the FEV1-AUC(0-60 min) after formoterol/budesonide was significantly larger than that after formoterol. Both treatments induced a significant reduction in VAS score but did not modify heart rate in a statistically significant manner. This study indicates that the addition of budesonide influences the fast onset of action of formoterol, but does not induce systemic effects, in patients with stable COPD. (C) 2004 Elsevier Ltd. All rights reserved.