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P131 Efficacy of tiotropium and olodaterol combination in patients with COPD on β-blockers
  1. E Derom1,
  2. S Korn2,
  3. A Hamilton3,
  4. VC Amatto4,
  5. Y Zhao5,
  6. F Maltais6
  1. 1Ghent University Hospital, Ghent, Belgium
  2. 2University Medical Center, Johannes Gutenberg University, Mainz, Germany
  3. 3Boehringer Ingelheim, Burlington, Ontario, USA
  4. 4Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany
  5. 5Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut, USA
  6. 6Centre de Recherche, Institut Universitaire de Cardiologie Et de Pneumologie de Québec, Québec, Canada

Abstract

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.

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.

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