Evidence suggests that small airway inflammation in asthma has a clinical impact apart from large airway function. Inhaled corticosteroids (ICSs) are the treatment of choice for persistent asthma, and measurement of forced expiratory flow between 25% and 75% of vital capacity (FEF25%–75%) is a good assessment of ICS effects on small airway function. Mometasone furoate delivered by a dry powder inhaler (MF-DPI) is an ICS approved for administration once daily in the evening (QD PM) for the maintenance treatment of asthma in patients aged ≥ 4 years. To determine whether MF-DPI QD PM can consistently improve FEF25%–75%, we performed a post hoc analysis of results from 4 clinical trials.
4 randomized, multicenter, placebo-controlled, double-blinded, 12-week trials in patients ≥ 12 years of age with mild to moderate persistent asthma were reviewed. FEF25%–75% was a secondary efficacy variable in each trial. Results from the MF-DPI 200αg and 400αg QD PM treatment arms, the only once-daily schedules currently approved, were reviewed in this analysis, as were results from the placebo groups.
Data from 1149 patients were analyzed. Of these patients, 482 received MF-DPI QD PM and 323 received placebo. Significant improvements in FEF25%–75% were observed at the first postbaseline evaluation (week 1 in 3 trials, day 4 in the other trial) in MF-DPI-treated patients compared with placebo-treated patients. These improvements were significant and sustained throughout treatment. Progressive increases in FEF25%–75% were generally observed from the first evaluation to each subsequent evaluation. Endpoint improvements ranged from 1.4% (in patients who stepped down to MF-DPI 200αg QD PM after a 2-week run-in on MF-DPI 200μg BID) to 37.2% after 200μg MF-DPI QD PM treatment, 32.9% to 39.8% after 400αg MF-DPI QD PM treatment, whereas changes ranging from –13.5% to 14.4% occurred after placebo treatment (P<0.01).
MF-DPI taken once daily in the evening significantly and consistently improved FEF25%–75% in patients with asthma.
Treatment with once-daily MF-DPI improves small airway function in patients with asthma.
Jill Karpel, Grant monies (from industry related sources) Schering-Plough Corporation, Genetech, Boehringer-Ingelheim, Forest, Alcon, Amphastar, Amgen, AstraZeneca, Cheisi, Sanofi-Aventis, UCB, and Wyeth.; Employee Schering-Plough Corporation; Consultant fee, speaker bureau, advisory committee, etc. Schering-Plough Corporation, Genetech, Boehringer-Ingelheim, Astra-Zeneca, GSK, Pfizer, Novartis, Abbott, Sepracor; No Product/Research Disclosure Information