Bronchodilation With Mometasone Furoate/Formoterol Fumarate Administered by Metered-Dose Inhaler With and Without a Spacer in Children With Persistent Asthma

BackgroundThe 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. MethodsThis 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 1sec (FEV1) 70% predicted. Subjects received MF/F MDI 100/10 mu g with/without spacer (AeroChamber Plus (R) with Flow-Vu (R) Anti-Static Valved Holding Chamber), F-Dry Powder Inhaler (F-DPI) 10 mu g, and placebo MDI with/without spacer in separate treatment periods. The primary endpoint was FEV1 area under the curve from 0 to 12hr (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. ResultsData from 87 subjects were analyzed. MF/F with spacer demonstrated a larger change in mean FEV1 AUC(0-12hr) versus placebo (115 vs. -9mL), with a treatment difference of 124mL (95% CI 94-154, P<0.001). Similarly, MF/F without spacer versus placebo resulted in a 102mL difference in mean-adjusted FEV1 AUC(0-12hr) (95% CI 73-131, P<0.001), whereas the difference between MF/F with spacer versus MF/F without spacer was 22mL (95% CI -8 to 52, P=0.144). The difference between F-DPI versus placebo was 106mL (95% CI 77-135, P<0.001). No unexpected adverse events were observed. ConclusionsIn this trial, MF/F MDI 100/10 mu g demonstrated significant bronchodilation in children aged 5-11years 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. (c) 2013 Wiley Periodicals, Inc.