Efficacy and safety of once-daily fluticasone furoate/vilanterol (FF/VI) versus twice-daily inhaled corticosteroids/long-acting ß2-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 ß2-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. The primary study endpoint was change from baseline in ACT total score at Week 12. RESULTS: Overall, 423 patients were randomized to receive study medication in France and Germany. The least-squares mean change (standard error) in ACT total score at Week 12 was 3.6 units with FF/VI and 2.8 with usual ICS/LABA, giving a treatment difference of 0.8 (95% confidence interval 0.1, 1.5; p = 0.033). Non-inferiority of FF/VI to usual ICS/LABA was confirmed at Weeks 6, 18 and 24. The observed safety profile for FF/VI in this study was in line with previous experience with FF/VI. CONCLUSIONS: These findings suggest that, in a tightly controlled randomized controlled trial setting, once-daily FF/VI provides similar asthma control over 24 weeks to usual, twice-daily ICS/LABA in patients with asthma that is uncontrolled on ICS alone. FF/VI was well tolerated.