Efficacy of tiotropium/olodaterol on lung volume, exercise capacity, and physical activity

Masakazu Ichinose,1 Yoshiaki Minakata,2 Takashi Motegi,3 Jun Ueki,4 Yasuhiro Gon,5 Tetsuo Seki,6 Tatsuhiko Anzai,7 Shuhei Nakamura,6 Kazuto Hirata8 1Department of Respiratory Medicine, Tohoku University Graduate School of Medicine, Sendai, 2Department of Respiratory Medicine, National Hospital Organization Wakayama Hospital, Wakayama, 3Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, 4Clinical Research Unit of Respiratory Pathophysiology, Juntendo University Graduate School of Health Care and Nursing, Chiba, 5Division of Respiratory Medicine, Department of Internal Medicine, Nihon University School of Medicine, 6Medical Division, Nippon Boehringer Ingelheim Co., Ltd, 7Clinical Information Division Data Science Center, Statistics Analysis Department 1, EPS Corporation, Tokyo, 8Osaka City University, Osaka, Japan Purpose: This study evaluated the efficacy of tiotropium/olodaterol vs tiotropium on lung function, exercise capacity, and physical activity in patients with COPD.Patients and methods: A total of 184 patients aged ≥40 years with COPD (Global Initiative for Chronic Obstructive Lung Disease stage II–IV) received tiotropium/olodaterol for 6 weeks, then tiotropium for 6 weeks, or vice versa. The primary endpoint was inspiratory capacity (IC) at peak post-dose.Results: Adjusted mean IC after 6-week treatment was 1.990 L with tiotropium/olodaterol vs 1.875 L with tiotropium (difference: 115 mL; 95% CI: 77, 153; p<0.0001). Forced expiratory volume in 1 s (difference: 105 mL; 95% CI: 88, 123), forced vital capacity (difference: 163 mL; 95% CI: 130, 197), and slow vital capacity (difference: 134 mL; 95% CI: 91, 176) improved with tiotropium/olodaterol (all p<0.0001). Adjusted mean 6-min walk distance was similar between treatments in the overall population but was significantly increased with tiotropium/olodaterol in the subgroup with Global Initiative for Chronic Obstructive Lung Disease stage III/IV at baseline (difference: 18.1 m; 95% CI: 2.3, 33.9; p=0.0254). In a post hoc analysis, tiotropium/olodaterol improved the values for ≥2.0 metabolic equivalents (difference: 5.0 min; 95% CI: 0.4, 9.7; p=0.0337).Conclusion: Tiotropium/olodaterol significantly improved IC compared with tiotropium and potentially enhanced the exercise capacity in COPD patients. A slight improvement in physical activity of relatively more than moderate intensity was also seen with tiotropium/olodaterol. Keywords: Japanese, COPD, FEV1, FVC, inspiratory capacit