Small Airway Function Is Consistently Improved in Asthma Patients Treated with Mometasone Furoate Delivered by a Dry Powder Inhaler

Background:  Small airway inflammation is believed to play a significant role in asthma. Forced expiratory flow between 25% and 75% of vital capacity (FEF_25%-75%) is considered a good measure of small airway function. Mometasone furoate delivered by dry powder inhaler (MF-DPI) is an inhaled corticosteroid (ICS) approved for administration once daily in the evening (QD PM) for maintenance treatment of asthma in patients aged ≥4 years. We examined data from 4 clinical trials to determine whether MF-DPI QD PM consistently improved FEF_25%-75%.

Methods: Results from 4 randomized, multicenter, placebo (PBO)-controlled, double-blind, 12-week trials in patients (≥12 years) with persistent asthma were reviewed and analyzed post hoc.  FEF_25%-75% was a secondary efficacy variable in each trial. Results for MF-DPI 200 µg QD PM, 400 µg QD PM, and PBO were reviewed in this analysis.

 

Results: Data from 1149 patients were analyzed: 482 received MF-DPI QD PM; 323 received PBO. Significant improvements in FEF_25%-75% were observed at the first postbaseline evaluation (week 1 in 3 trials; day 4 in 1 trial) in MF-DPI-treated patients vs PBO-treated patients. The improvements were significant and sustained throughout treatment. Progressive increases in FEF_25%-75% generally occurred from the first evaluation to subsequent evaluations. End point improvements ranged from 1.4% (in patients who stepped down to MF-DPI 200 µg QD PM after a 2-week run-in on MF-DPI 200 µg BID) to 37.2% after 200 µg MF-DPI QD PM, from 32.9% to 39.8% after 400 µg MF-DPI QD PM, and from –13.5% to 14.4% after PBO (P<.01).

Conclusions: MF-DPI QD PM significantly and consistently improved FEF_25%-75% in patients with asthma.