TY - JOUR T1 - Tiotropium and olodaterol fixed-dose combination <em>versus</em> mono-components in COPD (GOLD 2–4) JF - European Respiratory Journal JO - Eur Respir J DO - 10.1183/09031936.00136014 SP - ERJ-01360-2014 AU - Roland Buhl AU - François Maltais AU - Roger Abrahams AU - Leif Bjermer AU - Eric Derom AU - Gary Ferguson AU - Matjaž Fležar AU - Jacques Hébert AU - Lorcan McGarvey AU - Emilio Pizzichini AU - Jim Reid AU - Antony Veale AU - Lars Grönke AU - Alan Hamilton AU - Lawrence Korducki AU - Kay Tetzlaff AU - Stella Waitere-Wijker AU - Henrik Watz AU - Eric Bateman Y1 - 2015/01/08 UR - http://erj.ersjournals.com/content/early/2015/01/08/09031936.00136014.abstract N2 - Efficacy and safety of tiotropium+olodaterol fixed-dose combination (FDC) compared with the mono-components was evaluated in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) in two replicate, randomised, double-blind, parallel-group, multicentre, phase III trials. Patients received tiotropium+olodaterol FDC 2.5/5 μg or 5/5 μg, tiotropium 2.5 μg or 5 μg, or olodaterol 5 μg delivered once-daily via Respimat inhaler over 52 weeks. Primary end points were forced expiratory volume in 1 s (FEV1) area under the curve from 0 to 3 h (AUC0–3) response, trough FEV1 response and St George's Respiratory Questionnaire (SGRQ) total score at 24 weeks. In total, 5162 patients (2624 in Study 1237.5 and 2538 in Study 1237.6) received treatment. Both FDCs significantly improved FEV1 AUC0–3 and trough FEV1 response versus the mono-components in both studies. Statistically significant improvements in SGRQ total score versus the mono-components were only seen for tiotropium+olodaterol FDC 5/5 μg. Incidence of adverse events was comparable between the FDCs and the mono-components. These studies demonstrated significant improvements in lung function and health-related quality of life with once-daily tiotropium+olodaterol FDC versus mono-components over 1 year in patients with moderate to very severe COPD. Lung function and symptomatic benefits of daily tiotropium+olodaterol fixed-dose combination in moderate to very severe COPD http://ow.ly/DIKiY ER -