PURPOSE: Asthma treatment guidelines recommend inhaled corticosteroids (ICSs) as the foundation of initial controller therapy for patients with moderate persistent asthma. Herein, the efficacy of mometasone furoate dry powder inhaler (MF-DPI) was examined in patients with moderate asthma.
METHODS: The therapeutic effects of MF-DPI on patients with moderate persistent asthma were characterized by performing a subgroup analysis on data from a randomized, placebo-controlled trial involving mild- and moderate-persistent asthma patients ≥12y (primary-endpoint results have been presented elsewhere). The subgroup was formed by all patients whose FEV1 was 60%–80% predicted and whose AM and PM symptom scores and frequency of rescue medication use and nocturnal awakenings indicated suboptimal asthma control at baseline (ie, moderate asthma). The effects of MF-DPI 200μg BID, 200μg QD PM, 400μg QD PM (1×400μg), 400μg QD PM (2×200μg), or placebo were assessed at 12 weeks of treatment. All participating patients were ICS-dependent defined as patients exhibiting FEV1 decreases ≥10% following an ICS-reduction period.
RESULTS: At endpoint, FEV1 and % predicted FEV1 improved 18.3%–21.7% in the MF-DPI groups (n=200) versus 7.3% in the placebo group (n=52; P<0.001). Forced vital capacity also improved significantly in the MF-DPI groups versus placebo (P<0.01). Reductions in awakenings ranged from 40.4%–78.1% in the MF-DPI groups versus a 2.9% increase in the placebo group (P<0.05 for MF-DPI 400μg QD PM [2×200μg]). The mean changes in rescue medication use in the MF-DPI groups ranged from +2.9% to –39.7% versus +35.6% in the placebo group (P<0.02). At endpoint, the mean change in % symptom-free days (SFDs) ranged from 25.6–28.1 (AM) and 21.4–26.5 points (PM) for the MF-DPI groups versus 9.4 and 9.9 points, respectively, for placebo. These differences versus placebo were significant in all MF-DPI groups for AM SFDs and in both MF-DPI 400μg QD PM groups for PM SFDs (P<0.05).
CONCLUSION: Once-daily MF-DPI therapy resulted in effective asthma control in patients with moderate asthma at baseline.
CLINICAL IMPLICATIONS: Once-daily MF-DPI treatment was found effective in patients with moderate asthma at baseline.
DISCLOSURE: Jill Karpel, No Product/Research Disclosure Information; Grant monies (from industry related sources) Received grants from Schering-Plough; Consultant fee, speaker bureau, advisory committee, etc. Served on Speaker's Bureau and Advisory Boards for Schering-Plough.