A new formulation of fluticasone propionate/salmeterol in a metered-dose inhaler (MDI HFA) allows for the reduction of a daily dose of corticosteroid and provides optimal asthma control - A randomized, multi-center, non-inferiority, phase IV clinical study

Background: Improvement of the delivery method of inhaled corticosteroids and subsequent dose reduction can minimize the risk of unfavorable outcomes while providing optimal asthma control. Objective: This randomized, multi-center, non-inferiority, phase IV clinical study compared the efficacy and safety of a new formulation of fluticasone propionate/salmeterol (250 mu g/50 mu g, twice daily) administered in a metered-dose inhaler hydrofluoroalkane (MDI HFA) with a dry-powder inhaler (DPI) containing fluticasone propionate/salmeterol (500 mu g/50 mu g, twice daily). Methods: Adults with asthma (n = 231) were randomly assigned to either the study group (treated for 12 weeks with fluticasone propionate/salmeterol MDI HFA) or a control group (treated for 12 weeks with fluticasone propionate/salmeterol DPI). Asthma symptoms, exacerbations, short-acting beta(2) -agonist (SABA) use, physical activity, lung function, and general health status were assessed during four study visits. Results: Compared with the reference drug, the study drug decreased the incidence of daytime and night-time asthma symptoms, asthma exacerbations, self-administration of SABA, and the limitation of physical activity. Comparable improvement in peak expiratory flow ([MDI HFA] from 6.2 +/- 0.2 to 6.6 +/- 0.2 1/s vs. [DPI] from 6.0 +/- 0.2 to 6.9 +/- 0.2 1/s; p > 0.05), forced expiratory volume in one second, and forced vital capacity were obtained in both groups. Significantly lower incidence of hoarseness was observed in the study group ([MDI HFA] 0.0% vs. [DPI] 2.8%; p = 0.0267); no major differences were found for other adverse events. Conclusions: Fluticasone propionate/salmeterol (250 mu g/50 mu g, twice daily) MDI HFA provides optimal asthma control and is non-inferior to fluticasone propionate/salmeterol (500 mu g/50 mu g, twice daily) DPI.