Fluticasone Propionate/Salmeterol MDPI (AirDuo RespiClick®): A Review in Asthma

Abstract

The novel, easy-to-use, breath-actuated fluticasone propionate/salmeterol multidose dry powder inhaler (MDPI) (AirDuo RespiClick^®) was recently approved in the USA for twice-daily treatment of asthma in patients aged ≥ 12 years. This inhaled corticosteroid (ICS) and long-acting β₂-adrenoreceptor agonist (LABA) combination treatment is available in low-, mid- and high-dosage formulations (55/14, 113/14 and 232/14 μg, respectively). In 12-week, phase III trials in patients aged ≥ 12 years with persistent asthma, all three dosages of fluticasone propionate/salmeterol MDPI treatment produced significant improvements in lung function and other asthma symptoms compared with fluticasone propionate MDPI monotherapy or placebo MDPI. In a 26-week, phase III trial in this patient population, mid- and high-dosage fluticasone propionate/salmeterol MDPI were noninferior to mid- (250/50 μg) and high- (500/50 μg) dosage fluticasone propionate/salmeterol DPI (Advair Diskus^®), respectively, in terms of improvements in lung function. Treatment-emergent adverse events (TEAEs) with fluticasone propionate/salmeterol MDPI were mostly of mild to moderate severity, with no severe TEAEs deemed to be treatment related. Although long-term pharmacovigilance is required to fully establish its safety, given the ease of use and favorable characteristics of the device and its clinical efficacy at relatively low metered doses of the active moieties, fluticasone propionate/salmeterol MDPI is an important emerging treatment option in patients aged ≥ 12 years with asthma.