Effect of Once-Daily Evening Administration of Low-Dose Mometasone Furoate on Peak Expiratory Flow in Subjects With Mild-to-Moderate Persistent Asthma

RATIONALE: The ability of inhaled corticosteroid (ICS) therapy to improve peak expiratory flow (PEF) throughout the day is an important measure of asthma control. It was decided to analyze the effects on PEF measurements observed with once-daily evening (QD PM) dosing of mometasone furoate dry powder inhaler (MF-DPI) in different populations of asthma patients. METHODS: Two randomized, double-blind studies evaluated treatment with MF-DPI 220 mcg QD PM (n = 177) or placebo (n = 178) in 12 weeks of therapy for persistent asthma. Subjects in one study were ICS-naïve. Subjects in the other study were previously maintained on daily ICS therapy (75% were using fluticasone propionate), and completed a pre-baseline ICS reduction period. As a result, subjects in both studies were comparable at baseline with respect to lung function and were pooled for analysis. The analysis compared MF-DPI with placebo for changes from baseline in AM and PM PEF at endpoint. RESULTS: Treatment with MF-DPI 200 QD PM significantly improved AM and PM PEF. The mean change from baseline in AM PEF at endpoint was 28.01 L/min in the MF-DPI group, compared with 3.12 L/min in the placebo group (p < 0.0001). For PM PEF, the mean change from baseline was 21.06 L/min with MF-DPI, and 5.92 with placebo (p = 0.0022). CONCLUSIONS: Treatment with MF-DPI 220 mcg QD PM significantly improved both AM and PM PEF in patients with persistent asthma who were either ICS-naïve or previously maintained on daily ICS therapy.