Efficacy and safety of once-daily fluticasone furoate/vilanterol (FF/VI) versus twice-daily inhaled corticosteroids/long-acting β-agonists (ICS/LABA) in patients with uncontrolled asthma: An open-label, randomized, controlled trial.

Background: A variety of different fixed-dose combinations of inhaled corticosteroids/long-acting β-agonists (ICS/LABA) are available for the treatment of asthma. The aim of this 24-week, open-label, multicenter, Phase IIIb randomized controlled trial was to evaluate the efficacy and safety of once-daily fluticasone furoate/vilanterol (FF/VI; 100/25 or 200/25 μg) compared with twice-daily fixed combinations of ICS/LABA (fluticasone propionate/salmeterol [FP/S] and budesonide/formoterol [BUD/F]) as maintenance therapy in patients with uncontrolled asthma treated with ICS alone.

Methods: Adult patients with documented physician-diagnosed asthma ≥1 year with an Asthma Control Test (ACT) score ≥15 and < 20 were included.