Real-world efficacy and problems of once-daily use of inhaled steroid (fluticasone furoate) combined with long-acting beta-2 agonist (vilanterol) in Japanese patients with asthma

Abstract Objective: The Japanese drug use system allowed the “once-daily use” of inhaled corticosteroid (ICS) fluticasone furoate (FF) combined with a long acting beta-2 agonist (LABA) vilanterol (VI) against asthma for the first time in 2013. Until then, patients with asthma had to use ICS at least twice-daily. We investigated the real-world efficacy and problems of this drug (FF/VI). Methods: This was an open-label, uncontrolled, within-group time-series (before-after) design. Prior treatments of asthma (twice-daily use of ICS with or without LABA) were switched to once-daily use of FF/VI (200 μg/25 μg). Subjects were evaluated by lung function tests prior to, and 2–3 months after, the initiation of FF/VI. Questions on the asthma control test (ACT) and preference of drugs were asked to patients. Results: One hundred and twenty-eight Japanese asthma outpatients were enrolled from 2014–2018 and 107 subjects completed the study. Peak flow, instantaneous flow at 75% of the forced vital capacity (V75), V50, maximum mid-expiratory flow rate, forced expiratory volume in 1 s, and ACT score in FF/VI-using subjects were significantly increased (all p < 0.01). The percent predicted vital capacity and the inspiratory reserve volume were also increased significantly (all 0.01 < p < 0.05). Ninety-three percent of subjects declared they wanted to continue FF/VI in the future. Adverse effects including hoarseness and/or uncomfortable sensations in the throat were increased (16%). Conclusions: Once-daily use of FF/VI is a potent and effective treatment. Its effect was marked on larger airways and yielded a greater satisfaction in patients despite a higher incidence of local steroid effects.