PURPOSE: Treatment of persistent asthma with a long-acting β2-agonist (LABA) in combination with an inhaled corticosteroid (ICS) is known to reduce asthma exacerbations. We investigated the effect of mometasone furoate/formoterol (MF/F), a newly developed ICS/LABA, on the incidence of severe exacerbations.
METHODS: Data from two phase III, double-blind, multicenter, placebo-controlled studies comparing MF/F(100/10μg) versus MF(100μg), F(10μg), or placebo (n=182, n=188, n=188, n=188, respectively; 26weeks; 2-3week active run-in MF[100μg]) and MF/F(200/10μg) versus MF(200μg), F(10μg), and placebo (n=191, n=192, n=202, n=196, respectively; 26weeks; 2-3week active run-in MF[200μg]) were analyzed to investigate MF/F’s ability to reduce exacerbations in subjects (≥12y) with moderate asthma. Time-to-first severe asthma exacerbation (ie, deterioration of asthma resulting in emergency treatment, hospitalization, or treatment with additional medication; decrease in forced expiratory volume in 1 second >20% from baseline; or decrease in peak expiratory flow >30% from baseline for ≥2 consecutive days) was characterized.
RESULTS: After 26 weeks of treatment, MF/F(100/10μg) significantly reduced the incidence of severe exacerbations (16.5%) versus 28.2%, 44.7%, and 45.7% in the MF(100μg), F(10μg), and placebo groups, respectively (P≤0.006), resulting in an increased time-to-first exacerbation for MF/F(100/10μg)-treated subjects. No subjects were hospitalized; 3 required emergency treatment (F[10μg], n=2; placebo, n=1); and 41 required systemic corticosteroids (MF/F[100/10μg], n=3; MF[100μg], n=4; F[10μg], n=15; placebo, n=19). Similarly, in the MF/F(200/10μg) study, the incidence of severe exacerbations was lowest for MF/F(200/10μg)-treated subjects (30.4%) versus 33.9%, 54.0%, and 55.6% in the MF(200μg), F(10μg), and placebo groups, respectively (P<0.001 vs F[10μg] and placebo), resulting in an increased time-to-first exacerbation for MF/F(200/10μg)- versus F(10μg)- and placebo-treated subjects. Three subjects were hospitalized (MF/F[200/10μg], MF[200μg], and F[10μg], n=1); 10 required emergency treatment (MF[200μg], n=1; F[10μg], n=5; placebo, n=4); and 46 required systemic corticosteroids (MF/F[200/10μg], n=2; MF[200μg], n=5; F[10μg], n=20; placebo, n=19).
CONCLUSION: Treatment with MF/F(100/10μg) or MF/F(200/10μg) twice-daily resulted in significant reductions in the incidence of severe exacerbations in patients with moderate inadequately controlled asthma.
CLINICAL IMPLICATIONS: MF/F(100/10μg) or MF/F(200/10μg) twice-daily reduced the incidence of severe exacerbations in patients with uncontrolled moderate asthma.
DISCLOSURE: Robert Nathan, Grant monies (from industry related sources) Dr. Nathan has received grants and research support from Abbott, Alcon, AstraZeneca, Ception, Dey, Dyax, Genentech, GlaxoSmithKline, MAP, MedImmune, Novartis, Sanofi-Aventis, Schering-Plough, and TEVA.Dr. Meltzer received research/grant support and served as a consultant and on speaker bureau for Schering-Plough.; Employee Dr. Nolte is a full-time Employee of Merck Research Laboratories; Consultant fee, speaker bureau, advisory committee, etc. He has served as consultant or scientific advisor for Genentech, GlaxoSmithKline, Merck, Novartis, Schering-Plough, and TEVA. He has also participated in Speaker’s Bureaus for AstraZeneca, Genentech, GlaxoSmithKline, Novartis, Sanofi-Aventis, Schering-Plough and UCB.; Product/procedure/technique that is considered research and is NOT yet approved for any purpose. Mometasone furoate/formoterol is a new ICS/LABA combination treatment currently under review by the US Food and Drug Administration as a potential new treatment for persistent asthma.