Effect of tiotropium and olodaterol on symptoms and patient-reported outcomes in patients with COPD: results from four randomised, double-blind studies

摘要

Chronic obstructive pulmonary disease is associated with significant morbidity and mortality. Trials of maintenance chronic obstructive pulmonary disease treatments focus on improvement in lung function and reductions in exacerbations, while patients are much more concerned about symptoms and health status. Our aim was to investigate the effects of tiotropium鈥?鈥塷lodaterol on patient-reported health outcomes, breathlessness and night-time rescue medication use in patients with chronic obstructive pulmonary disease, compared to placebo, tiotropium or olodaterol monotherapy. Two pairs of replicate, phase III studies of 12 (OTEMTO 1鈥?鈥?) and 52 weeks鈥?(TONADO 1鈥?鈥?) duration were evaluated, in which patients received either tiotropium鈥?鈥塷lodaterol 2.5/5 or 5/5鈥壩糶, tiotropium 2.5 or 5鈥壩糶, olodaterol 5鈥壩糶 or placebo, all delivered once daily via Respimat inhaler. Patient-reported outcomes included breathlessness assessed by transition dyspnoea index focal score, health status assessed by St George鈥檚 Respiratory Questionnaire total score and night-time rescue medication use at 12 or 24 weeks. Outcomes from the pooled study data are reported. Overall, 1621 and 5162 patients were treated in the OTEMTO and TONADO trials, respectively. Significantly larger improvements in St George鈥檚 Respiratory Questionnaire and transition dyspnoea index focal scores were observed and a greater proportion of patients were responders to therapy (based on minimum clinically important differences in St George鈥檚 Respiratory Questionnaire and transition dyspnoea index) with tiotropium鈥?鈥塷lodaterol compared to either monotherapy or to placebo. Tiotropium鈥?鈥塷lodaterol 5/5鈥壜礸 significantly reduced night-time rescue medication usage.