Efficacy and safety evaluation of once-daily fluticasone furoate/vilanterol in Asian patients with asthma uncontrolled on a low- to mid-strength inhaled corticosteroid or low-dose inhaled corticosteroid/long-acting beta2-agonist

Background: Response to inhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA) combinations varies across ethnic groups. Objective: To investigate the efficacy and safety of the ICS/LABA combination fluticasone furoate/vilanterol (FF/VI) 100/25 mu g in Asian patiens with asthma. Methods: A randomized (1:1), 12-week, double-blind, placebo controlled, parallel group, multicenter phase III study once-daily FF/VI 100/25 mu g versus placebo in patients of Asian ancestry ages >= 12 years with asthma, uncontrolled on to ruin strength ICS or low-dose ICS/LABA. The primary, end point was the mean change from baseline in the daily evening peak expiratory flow. Secondary end points were the mean change from baseline in percentage rescue free 24-hour periods, daily morning peak expiratory flow, percentage symptoin-f-ree 24 hour periods, Asthma Quality of Life Questionnaire score, adverse events, and severe exacerbations. Results: The intent-to-treat population was 507 patients. There,ere significant (p < 0.001) improvements from baseline for FF/VI 100/25 mu g versus placebo in evening peak expiratory flow (51.0 L/min [95% confidence interval (Cl), 42.2-59.7 L/min]) and all secondary end points (percentage rescue-free 24-hour periods 21.8% [95% CI, 14.6-29.1%], morning peak expiratory flow 52.9 L/min 195% CI, 44.2-61.6 Llini221; percentage symptom free 24-hour periods 15.8% 195% CI, 9.4-22.3%]; Asthma Quality of Life Questionnaire score 0.52 [95% CI, 0.28, 0.75]). On-treatment adverse events were 35% with FF/VI (n = 2 [serious]), 31% with placebo; severe exacerbations were FF/VI (12 = 1), placebo (n = 7). Conclusions: In patients of Asian ancestry, once-daily FF/VI 100/25 /..t.g produced statistically and clinics I i significant improveineiits in efficacy end points versus placebo, with a generally similar safety profile. Results were consistent with a global phase III study of FF/VI 100/25 mu g. Clinicaltrials.gav NCT01498679.