Efficacy of Once-Daily Tiotropium and Olodaterol Maintenance Treatment for COPD: Patient-Reported Outcomes

Abstract

Purpose: Chronic obstructive pulmonary disease (COPD) is a highly symptomatic and debilitating condition. The efficacy and safety of a new once-daily (QD) maintenance treatment of tiotropium (T), a long-acting muscarinic antagonist, in combination with olodaterol (O), a longacting β-agonist, in moderate to severe COPD was demonstrated in the TONADO™ studies (NCT01431274; NCT01431287). Here we present new data on patient-reported health assessments from these trials. Methods: Two randomized, double-blind, parallel-group, 52-week, Phase III trials assessed T+O (2.5/5 μg; 5/5 μg; via Respimat® inhaler) QD compared to O 5 μg and T 2.5 or 5 μg. To ascertain whether improvements in lung function are associated with symptom reduction for patients, we present data from the combined analysis of the two studies for patient global rating (PGR) assessments, measured by scoring of their health status (related to their respiratory condition) from 1 (very much better) to 7 (very much worse), from the TONADO™ trials after 52 weeks of treatment. Results: 5162 patients were randomized and treated. Significant decreases (i.e. improvements) in PGR health-status scores were observed with both doses of T+O compared to monocomponents at 52 weeks. The adjusted mean treatment difference was -0.217 for T+O 5/5 μg versus O 5 μg (95% confidence interval [CI] -0.315, -0.119; p<0.0001) and -0.197 versus T 5 μg (95% CI -0.295, -0.100; p<0.0001). Treatment differences were also significant for T+O 2.5/5 μg versus monocomponents. Treatment differences between T+O 2.5/5 μg and 5/5 μg were not significant. Conclusions: In addition to the sustained improvements in lung function demonstrated in the TONADO™ studies, T+O provides long-term improvements in patient-reported health status. Clinical Implications: These data demonstrate that appropriate maintenance therapy can improve not only lung function in patients with COPD, but also, as importantly, symptoms, and, therefore, quality of life. Funding: Boehringer Ingelheim. Editorial assistance: Complete HealthVizion.