{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,13]],"date-time":"2026-07-13T15:31:04Z","timestamp":1783956664826,"version":"3.55.0"},"reference-count":32,"publisher":"European Respiratory Society (ERS)","issue":"6","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Eur Respir J"],"accepted":{"date-parts":[[2013,5,15]]},"published-print":{"date-parts":[[2013,12]]},"abstract":"<jats:p>We investigated the efficacy and safety of dual bronchodilation with QVA149<jats:italic>versus<\/jats:italic>its monocomponents indacaterol and glycopyrronium, tiotropium and placebo in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).<\/jats:p><jats:p>This was a multicentre, randomised, double-blind, placebo- and active-controlled, 26-week trial. Patients (n = 2144) were randomised (2:2:2:2:1) to receive once-daily QVA149 (indacaterol 110 \u03bcg\/glycopyrronium 50 \u03bcg), indacaterol 150 \u03bcg, glycopyrronium 50 \u03bcg, open-label tiotropium 18 \u03bcg or placebo. The primary end-point was trough forced expiratory volume in 1 s (FEV<jats:sub>1<\/jats:sub>) at week 26 for QVA149<jats:italic>versus<\/jats:italic>its monocomponents. Secondary end-points included dyspnoea, health status, rescue medication use and safety.<\/jats:p><jats:p>Trough FEV<jats:sub>1<\/jats:sub>at week 26 was significantly improved (p&lt;0.001) with QVA149 compared with indacaterol and glycopyrronium (least squares mean (LSM) differences 0.07 L and 0.09 L, respectively), tiotropium and placebo (LSM differences 0.08 L and 0.20 L, respectively); these beneficial effects were sustained throughout the 26-week study. QVA149 significantly improved dyspnoea and health status<jats:italic>versus<\/jats:italic>placebo (p&lt;0.001 and p = 0.002, respectively) and tiotropium (p = 0.007 and p = 0.009, respectively) at week 26. All treatments were well tolerated.<\/jats:p><jats:p>Dual bronchodilation with once-daily QVA149 demonstrated superior and clinically meaningful outcomes<jats:italic>versus<\/jats:italic>placebo and superiority<jats:italic>versus<\/jats:italic>treatment with a single bronchodilator, with a safety and tolerability profile similar to placebo, supporting the concept of fixed-dose long-acting muscarinic antagonist\/long-acting \u03b2<jats:sub>2<\/jats:sub>-agonist combinations for the treatment of COPD.<\/jats:p>","DOI":"10.1183\/09031936.00200212","type":"journal-article","created":{"date-parts":[[2013,5,31]],"date-time":"2013-05-31T05:55:01Z","timestamp":1369979701000},"page":"1484-1494","source":"Crossref","is-referenced-by-count":265,"title":["Dual bronchodilation with QVA149<i>versus<\/i>single bronchodilator therapy: the SHINE study"],"prefix":"10.1183","volume":"42","author":[{"given":"Eric D.","family":"Bateman","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gary T.","family":"Ferguson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neil","family":"Barnes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicola","family":"Gallagher","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yulia","family":"Green","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michelle","family":"Henley","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Donald","family":"Banerji","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"81","published-online":{"date-parts":[[2013,5,30]]},"reference":[{"key":"2024102021412030000_42.6.1484.1","unstructured":"Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2013. www.goldcopd.org\/guidelines-global-strategy-for-diagnosis-management.html Date last accessed: February 11, 2013. 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