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RESEARCH PRODUCT

Efficacy of tiotropium and olodaterol fixed-dose combination in patients with COPD on β-blockers

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Introduction: The efficacy and safety of a new once-daily (QD) fixed-dose combination (FDC) with tiotropium (T), a long-acting muscarinic antagonist, and olodaterol (O), a long-acting β 2 -agonist, was established for the treatment of COPD in the TONADO studies (NCT01431274; NCT01431287). This analysis evaluates the efficacy of the FDC in a subpopulation of patients receiving β-blockers (BBs) in these studies. Methods: Two replicate, randomised, double-blind, parallel-group, 52-week, Phase III trials assessed the efficacy and safety of T+O FDC (2.5/5 μg; 5/5 μg; Respimat ® inhaler) QD compared to the monocomponents. Key primary end point data for the combined analysis of the replicate trials in patients with COPD receiving BBs during treatment are presented. Results: 5136 patients were evaluable; 556 (10.8%) received BBs. At 24 weeks, similar improvements in mean FEV 1 AUC 0–3 responses for T+O FDCs compared to monocomponents were seen across BB subgroups (Table), with no significant treatment interaction effect observed. A similar trend was observed with trough FEV 1 and quality of life scores. Safety data will be described elsewhere. Conclusions: While the BB patient group analysed was small, these data demonstrated similar sustained improvements in lung function, irrespective of BB use. These data support the efficacy of T+O FDC in this patient group. Funding: Boehringer Ingelheim.