Rationale The efficacy and safety of a new once-daily combination with tiotropium (T), a long-acting muscarinic antagonist, and olodaterol (O), a long-acting β2-agonist, was established for the treatment of chronic obstructive pulmonary disease (COPD) in the TONADO studies (NCT01431274; NCT01431287). This analysis evaluates the efficacy of the combination in a subpopulation of patients receiving β-blockers in these studies.
Methods Two replicate, randomised, double-blind, parallel-group, 52-week, Phase III trials assessed the efficacy and safety of T+O (2.5/5 μg; 5/5 μg; via Respimat® inhaler) once daily compared to the monocomponents. Key primary end-point data for the combined analysis of the replicate trials in patients with COPD receiving β-blockers during treatment are presented.
Results 5136 patients were evaluable; 556 (10.8%) received β-blockers. At 24 weeks, similar improvements in mean forced expiratory volume in 1 s (FEV1) area under the curve from 0–3 h (AUC0–3) responses for T+O compared to monocomponents were seen across β-blocker subgroups (Table 1), with no significant treatment interaction effect observed. A similar trend was observed with trough FEV1 and quality of life scores.
Conclusions While the β-blocker patient group analysed was small, these data demonstrated similar sustained improvements in lung function, irrespective of β-blocker use. These data support the efficacy of T+O in this patient group.
Funding Boehringer Ingelheim.