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RESEARCH PRODUCT

P131 Efficacy of tiotropium and olodaterol combination in patients with COPD on β-blockers: Abstract P131 Table 1

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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][1]; [NCT01431287][2]). 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][3]), with no significant treatment interaction effect observed. A similar trend was observed with trough FEV1 and quality of life scores. View this table: Abstract P131 Table 1 Efficacy of T+O versus monocomponents by β-blocker use 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. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01431274&atom=%2Fthoraxjnl%2F70%2FSuppl_3%2FA142.1.atom [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01431287&atom=%2Fthoraxjnl%2F70%2FSuppl_3%2FA142.1.atom [3]: #T1