PURPOSE: To assess disease-specific quality-of-life in subjects with persistent asthma treated 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 phase III, randomized, multicenter, double-blind studies assessed the effects of MF/F-100/10μg, -200/10μg, or -400/10μg on lung function and/or exacerbations in asthma subjects previously receiving low-, medium-, or high-dose ICS, respectively: 1) study P04073 (26 weeks; 2−3week 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 (26 weeks; 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 (12 weeks; 2−3 week run-in MF-400μg): MF/F-400/10μg (n=255), MF/F-200/10μg (n=233), and MF-400μg (n=240). All doses were twice-daily (BID). The Asthma Quality of Life Questionnaire (AQLQ[S]) includes 32 questions scored (1=worst; 7=best). Changes from baseline in AQLQ(S) scores were measured at week 4 and study endpoint for all 3 studies and also at week 12 for P04073 and P04334. A minimal important difference (MID) in improvement was defined as ≥0.5.
RESULTS: In studies P04073 and P04334, improvements in AQLQ(S) score were statistically significant for MF/F-100/10 μg and -200/10 μg compared with F-10 μg and placebo at all time points assessed (all comparisons P<0.001); improvements were >4-fold higher at all time points for MF/F-100/10 μg and 2-10 fold higher and all time points for MF/F-200/10 μg compared with F-10 μg and placebo, respectively. An MID was achieved for MF/F-100/10 μg and -200/10 μg (but not MF or F doses) compared with placebo at endpoint in studies P04073 and P04334. In study P04431, improvements in AQLQ(S) score for MF/F-400/10 μg were higher than for MF-400 μg and reached statistical significance at week 4 (P=0.004).
CONCLUSION: MF/F-100/10μg, -200/10μg, and -400/10μg BID improved the disease-specific quality-of-life of asthma subjects uncontrolled on low-, medium-, and high-dose ICS treatment, respectively; an MID was achieved with MF/F-100/10μg and -200/10μg versus placebo.
CLINICAL IMPLICATIONS: MF/F treatment yielded significant disease-specific quality-of-life improvements in subjects with uncontrolled moderate/severe asthma.
DISCLOSURE: Kevin Murphy, Grant monies (from industry related sources) Dr. Murphy receives research support from AstraZeneca, GlaxoSmithKline, Merck, Novartis, and Schering-Plough.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, advisoμry committee, etc. K. Murphy received honoraria for consulting services from AstraZeneca, Dey, Merck, and Schering-Plough. This work was supported by Schering Corp., a Division of Merck & Co.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.