Efficacy and safety of once-daily fluticasone furoate/vilanterol (FF/VI) versus twice-daily inhaled corticosteroids/long-acting β2-agonists (ICS/LABA) in patients with uncontrolled asthma: An open-label, randomized, controlled trial.

Abstract

A variety of different fixed-dose combinations of inhaled corticosteroids/long-acting β2-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. 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. 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. 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.