Onset and Duration of Action of Formoterol and Tiotropium in Patients with Moderate to Severe COPD

Abstract

Background: Chronic obstructive pulmonary disease (COPD) management guidelines recommend regular treatment with one or more long-acting bronchodilators for patients with moderate to severe COPD. Objective: To compare the onset and duration of action of formoterol and tiotropium in patients with COPD. Methods: This randomized, multicentre, open-label crossover study in 38 patients with COPD (mean age 64 years; mean FEV1 55% predicted) assessed the effect of 7 days of treatment with formoterol (12 µg b.i.d. via Foradil® Aerolizer®) vs. tiotropium (18 µg o.d. via Spiriva® HandiHaler®) on lung function measured over a period of 12 h after the first dose on day 1 and the last dose on day 8. Results: The primary efficacy variable, FEV1-AUC during the first 2 h post-dose (FEV1-AUC10–120 min), was significantly higher for formoterol compared with tiotropium, with between-treatment differences of 124 ml (p = 0.016) after the first dose and 80 ml (p = 0.036) after 7 days’ treatment in favour of formoterol. FEV1 measured 12 h after inhalation did not differ statistically significantly between treatments. Adverse events occurred in 2 (5%) patients after treatment with formoterol and in 5 (12%) patients after treatment with tiotropium. Conclusion: This study demonstrates faster onset of action and greater bronchodilation of formoterol vs. tiotropium for bronchodilation within the first 2 h of inhalation (FEV1-AUC10–120 min) and comparable bronchodilation 12 h post-inhalation in patients with moderate to severe COPD.