This 24-week, multicentre, randomised, double-blind, double-dummy, 3-arm, parallel-group trial (NCT03034915; GSK study: 201749) was conducted between June 2017 and June 2018 in 213 centres in Germany, USA, Argentina, Sweden, Canada, Italy, South Africa, Netherlands, Spain, Australia, France, and Mexico. Patients were randomised 1:1:1 to once-daily fixed-dose combination UMEC/VI (62.5/25 μg) via the ELLIPTA inhaler and twice-daily placebo via the DISKUS inhaler, once-daily UMEC (62.5 μg) via ELLIPTA inhaler and twice-daily placebo via DISKUS, or twice-daily salmeterol (50 μg) via DISKUS and once-daily placebo via ELLIPTA inhaler (Additional file 6: Figure S1). Salmeterol was selected as a comparator as no once-daily LABAs were approved at standard doses in all countries participating in the study; its use also allowed the LABA treatment to be easily blinded compared with the alternative twice-daily LABA, formoterol. UMEC was selected as it is a component of the dual bronchodilator and it has also demonstrated superior lung function benefits compared with tiotropium [17 (link)].
This study was performed according to the Declaration of Helsinki and received appropriate ethical approval. All patients provided written informed consent via a form signed at either the Pre-screening or Screening visit.
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