2015
DOI: 10.1183/09031936.00136014
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Tiotropium and olodaterol fixed-dose combinationversusmono-components in COPD (GOLD 2–4)

Abstract: 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 i… Show more

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Cited by 304 publications
(474 citation statements)
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“…Nevertheless, a numerical difference in the CAT responder analysis was seen at week 8, with 47% of UMEC/VI-treated patients compared with 38% of TIO/OLO-treated patients obtaining clinically relevant improvements in symptoms and health-related QoL, with a similar response rate at week 4, in line with the primary study. This magnitude of improvement in symptom burden and QoL is consistent with treatment benefit on CAT and other patientreported outcomes seen on escalating therapy from one to two bronchodilators in patients with more advanced COPD [37,39,40].…”
Section: Discussionsupporting
confidence: 61%
“…Nevertheless, a numerical difference in the CAT responder analysis was seen at week 8, with 47% of UMEC/VI-treated patients compared with 38% of TIO/OLO-treated patients obtaining clinically relevant improvements in symptoms and health-related QoL, with a similar response rate at week 4, in line with the primary study. This magnitude of improvement in symptom burden and QoL is consistent with treatment benefit on CAT and other patientreported outcomes seen on escalating therapy from one to two bronchodilators in patients with more advanced COPD [37,39,40].…”
Section: Discussionsupporting
confidence: 61%
“…In the current issue of the European Respiratory Journal, a novel candidate of this drug combination principle is presented by BUHL et al [7]. Two replicate phase III trials aimed to assess the efficacy and safety of inhaled tiotropium+olodaterol FDC 5/5 µg or 2.5/5 µg delivered via the Respimat Soft Mist inhaler compared with their individual mono-components in patients with moderate-to-very-severe COPD (Global Initiative for Chronic Obstructive Lung Disease stage 2-4) over 52 weeks.…”
Section: @Erspublicationsmentioning
confidence: 99%
“…Lung deflation, therefore, represents an important underlying mechanism that drives the reduction in exacerbations, as well as the potentially beneficial effect on cardiac function and survival. The recently developed combinations of LABD may further improve these clinical outcomes by providing more effective bronchodilation and potential lung deflation compared to single agents (29)(30)(31).…”
mentioning
confidence: 99%