Bronchodilation with mometasone furoate/formoterol fumarate administered by metered‐dose inhaler with and without a spacer in children with persistent asthma

Summary Background The bronchodilatory effect of mometasone furoate/formoterol fumarate (MF/F) administered by metered‐dose inhaler (MDI) with or without a spacer has not been evaluated previously in children aged 5–11 years. Methods This was a randomized, multicenter, placebo‐controlled, single‐dose, four‐period crossover study. Children with persistent asthma aged 5–11 years participated in this study. Subjects used inhaled corticosteroids with/without long‐acting beta‐2 agonists for 12 weeks before enrollment and at screening had forced expiratory volume in 1 sec (FEV 1 ) ≥70% predicted. Subjects received MF/F MDI 100/10 µg with/without spacer (AeroChamber Plus® with Flow‐Vu® Anti‐Static Valved Holding Chamber), F‐Dry Powder Inhaler (F‐DPI) 10 µg, and placebo MDI with/without spacer in separate treatment periods. The primary endpoint was FEV 1 area under the curve from 0 to 12 hr (AUC 0–12hr ) for the comparison of MF/F with spacer versus placebo. Secondary measurements included MF/F without spacer versus placebo, as well as MF/F with spacer versus MF/F without spacer, and F‐DPI versus placebo. Analysis was performed with an analysis of covariance model for a crossover study. Results Data from 87 subjects were analyzed. MF/F with spacer demonstrated a larger change in mean FEV 1 AUC 0–12hr versus placebo (115 vs. −9 mL), with a treatment difference of 124 mL (95% CI 94–154, P  < 0.001). Similarly, MF/F without spacer versus placebo resulted in a 102 mL difference in mean‐adjusted FEV 1 AUC 0–12hr (95% CI 73–131, P  < 0.001), whereas the difference between MF/F with spacer versus MF/F without spacer was 22 mL (95% CI −8 to 52, P  = 0.144). The difference between F‐DPI versus placebo was 106 mL (95% CI 77–135, P  < 0.001). No unexpected adverse events were observed. Conclusions In this trial, MF/F MDI 100/10 µg demonstrated significant bronchodilation in children aged 5–11 years regardless of the use of a spacer. No difference in bronchodilation was observed between MF/F MDI and F‐DPI. Pediatr Pulmonol. 2014; 49:441–450. © 2013 Wiley Periodicals, Inc.