Effects of arformoterol twice daily, tiotropium once daily, and their combination in patients with COPD

Summary Purpose Current guidelines support using in combination more than one class of long-acting bronchodilator for COPD patients whose symptoms are not controlled by mono-therapy. This 2-week, multi-center (34 sites), randomized, modified-blind, parallel group study evaluated the efficacy and safety of concomitant treatment with nebulized arformoterol (the formoterol( R , R )-isomer) BID and tiotropium DPI QD. Methods COPD patients (mean FEV 1 1.37L, 45.4% predicted) were randomized to receive mono-therapy (either arformoterol 15μg BID [ n =76] or tiotropium 18μg QD [ n =80]), or combined therapy (sequential dosing of arformoterol 15μg BID and tiotropium 18μg QD [ n =78]). Changes in pulmonary function, dyspnea, and rescue levalbuterol use were evaluated, as were safety outcomes. Results Mean FEV 1 AUC 0–24 (the primary endpoint) improved similarly from baseline for arformoterol (0.10L) and tiotropium (0.08L) treatment groups and greater for the combined therapy group (0.22L; all p -values 1 , peak FVC, 24-h trough FEV 1 , and inspiratory capacity also improved similarly for the mono-therapies and greatest for the combined therapy. Dyspnea (mean transition dyspnea index) improved similarly for arformoterol (+2.3) and tiotropium (+1.8) and greatest with combined therapy (+3.1; p -values Conclusion In this study, the combination of nebulized arformoterol 15μg BID plus tiotropium 18μg DPI QD was the most effective in improving pulmonary function and disease symptoms. Mono-therapy improvement with arformoterol or tiotropium was similar. All three treatments were well tolerated.