PURPOSE: To assess asthma control in subjects with persistent asthma receiving treatment with mometasone furoate/formoterol (MF/F), a newly-developed inhaled corticosteroid (ICS)/long-acting β2-agonist combination, administered via a pressurized metered-dose inhaler.
METHODS: Three double-blind, randomized, phase III, multicenter studies assessed MF/F(100/10μg), MF/F(200/10μg), or MF/F(400/10μg) in asthma subjects previously receiving ICS: 1) study P04073 (26weeks; 2-3-week-run-in MF[100μg]): MF/F(100/10μg; n=182), MF(100μg; n=188), F(10μg; n=188), and placebo (n=188); 2) study P04334 (26weeks; 2-3-week-run-in MF[200μg]): MF/F(200/10μg; n=191), MF(200μg; n=192), F(10μg; n=202), and placebo (n=196); 3) study P04431 (12weeks; 2-3-week-run-in MF[400μg]): MF/F(400/10μg; n=255), MF/F(200/10μg; n=233), and MF(400μg; n=240). Doses were twice-daily. Key secondary endpoints of each study included mean Asthma Control Questionnaire (ACQ) scores at: week-4, week-12, and study endpoint (P04073/P04334); and week-4 and study endpoint (P04431). Least squares (LS) mean score changes from baseline were calculated using analysis of covariance. A ≥0.5-point change in ACQ score was considered clinically relevant (minimal important difference [MID]).
RESULTS: In study P04073, LS-mean ACQ score changes were significantly better for MF/F(100/10μg) versus: MF(100μg), F(10μg), and placebo at week-4 (−0.35 vs −0.20, −0.07, and 0.07, respectively) and week-12 (−0.43 vs −0.22, −0.12, and −0.06, respectively); and F(10−g) and placebo at endpoint (−0.36 vs 0.07 and 0.24, respectively; MID achieved for MF/F vs placebo) (P≤0.023). Study P04334 LS-mean score changes were significantly better for MF/F(200/10μg) versus: F(10μg) and placebo at week-4 (−0.34 vs 0.04 and 0.05, respectively); MF(200μg), F(10μg), and placebo at week-12 (−0.45 vs −0.22, −0.12, and −0.04, respectively); and MF(200−g), F(10−g), and placebo at endpoint (−0.40 vs −0.23, 0.11, and 0.14, respectively; MID achieved for MF/F vs placebo) (P−0.026). Study P04431 LS-mean score changes were significantly better for both MF/F(200/10−g) and MF/F(400/10−g) versus MF(400−g) at week-4 (−0.43 vs −0.46, −0.24, respectively) and endpoint (−0.56 vs −0.51, −0.33, respectively; MID achieved in both MF/F groups) (P≤0.008).
CONCLUSION: MF/F was more effective in controlling asthma than MF, F, and placebo at most time points.
CLINICAL IMPLICATIONS: These data support the use of MF/F for management of inadequately-controlled moderate-to-severe persistent asthma.
DISCLOSURE: Martha White, Grant monies (from industry related sources) Dr. Meltzer received research/grant support and served as a consultant and on speaker bureau for Schering-Plough.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.; Employee Dr. Nolte is a full-time Employee of Merck Research Laboratories; Consultant fee, speaker bureau, advisory committee, etc. Dr. White is a consultant for GSK; Schering Plough; Nabi; AZ; Dyax; Viropharma; Novartis; Genentech; MedImmune; Boehringer; Researchsupport; SpineWave; AZ;.Dr. Nathan has served as consultant or scientific advisor for Genentech, GlaxoSmithKline, Merck, Novartis, Schering-Plough, and TEVA. Dr. Nathan 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.