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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Dual bronchodilation with QVA149 versus single bronchodilator therapy: The SHINE study
European Respiratory Journal, Volume 42, No. 6, Year 2013
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Description
We investigated the efficacy and safety of dual bronchodilation with QVA149 versus its monocomponents indacaterol and glycopyrronium, tiotropium and placebo in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). 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 μg/glycopyrronium 50 μg), indacaterol 150 μg, glycopyrronium 50 μg, open-label tiotropium 18 μg or placebo. The primary end-point was trough forced expiratory volume in 1 s (FEV1) at week 26 for QVA149 versus its monocomponents. Secondary end-points included dyspnoea, health status, rescue medication use and safety. Trough FEV1 at week 26 was significantly improved (p<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 versus placebo (p<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. Dual bronchodilation with once-daily QVA149 demonstrated superior and clinically meaningful outcomes versus placebo and superiority versus 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 β2-agonist combinations for the treatment of COPD. Copyright © ERS 2013.
Authors & Co-Authors
Bateman, E. D.
South Africa, Cape Town
University of Cape Town
Ferguson, Gary Thomas
United States, Livonia
Pulmonary Research Institute of Southeast Michigan
Barnes, Neil C.
United Kingdom, London
London Chest Hospital
Gallagher, Nicola
United Kingdom, Horsham
Novartis Horsham Research Centre
Green, Yulia
United Kingdom, Horsham
Novartis Horsham Research Centre
Henley, Michelle
United Kingdom, Horsham
Novartis Horsham Research Centre
Banerji, Donald D.
Switzerland, Basel
Novartis International ag
Statistics
Citations: 404
Authors: 7
Affiliations: 5
Identifiers
Doi:
10.1183/09031936.00200212
ISSN:
09031936
e-ISSN:
13993003
Research Areas
Disability
Noncommunicable Diseases