Source: International Congress 2015 – New data on established treatments for asthma, COPD and bronchiectasis
Disease area: Airway diseases

Abstract

Introduction: Efficacy and safety of the fixed-dose combination (FDC) of tiotropium (T), a long-acting muscarinic antagonist, + olodaterol (O), a long-acting b₂-agonist, has previously been established in pivotal Phase III studies in COPD. The present studies (OTEMTO 1 and 2) evaluated FEV₁ and SGRQ score after 12 weeks of treatment with T+O FDC (2.5/5 µg; 5/5 µg) and T 5 µg compared to placebo (P) in patients with moderate to severe COPD.Methods: Two randomised, double-blind, parallel-group, Phase IIIb studies assessed the efficacy and safety of T 5 µg, T+O FDC 2.5/5 µg or 5/5 µg compared to P. Key inclusion criteria were age ³40 years, diagnosis of COPD and post-bronchodilator FEV₁ ³30 and <80% predicted (GOLD 2–3).Results: 1621 patients were evaluated. Patient characteristics were similar between OTEMTO 1 and 2: mean post-bronchodilator FEV₁ was 1.52 L and 1.55 L [55.3% and 54.8% predicted], respectively. Both studies met primary end points and significantly improved FEV₁ AUC_0–3, trough FEV₁ and SGRQ with all treatments versus P (Table). There were no relevant safety findings.Conclusions: These studies show a consistent clinically meaningful improvement in SGRQ with T+O FDC 5/5 µg versus P, while confirming its effects on lung function parameters and safety.



Funding: Boehringer Ingelheim.


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Dave Singh (Manchester, United Kingdom), Dave Singh, Gary T. Ferguson, Josef Bolitschek, Lars Grönke, Christoph Hallmann, Nathan Bennett, Roger Abrahams, Olaf Schmidt, Leif Bjermer. Tiotropium + olodaterol fixed-dose combination shows clinically meaningful improvements in quality of life versus placebo. Eur Respir J 2015; 46: Suppl. 59, 2958

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