Bronchodilation with mometasone furoate/formoterol fumarate administered by metered‐dose inhaler with and without a spacer in children with persistent asthma. Issue 5 (9th September 2013)

• Record Type: Journal Article
• Authors: Berger, William E.; Bensch, George W.; Weinstein, Steven F.; Skoner, David P.; Prenner, Bruce M.; Shekar, Tulin; Nolte, Hendrik; Teper, Ariel A.
• Is Part Of: Pediatric pulmonology. Volume 49:Issue 5(2014:May)
• Page Start: 441
• Page End: 450
• Publication Date: 2013-09-09
• Subjects: Pediatric respiratory diseases -- Periodicals; Pediatrics -- Periodicals; 618.922
• DOI: 10.1002/ppul.22850
• Languages: English
• ISSNs: 8755-6863

Abstract

<abstract abstract-type="main" xml:lang="en"> <title>Summary</title> <sec id="ppul22850-sec-0001" sec-type="section"> <title>Background</title> <p>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.</p> </sec> <sec id="ppul22850-sec-0002" sec-type="section"> <title>Methods</title> <p>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<sub>1</sub>) ≥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<sub>1</sub> area under the curve from 0 to 12 hr (AUC<sub>0–12hr</sub>) 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.</p> </sec> <sec id="ppul22850-sec-0003" sec-type="section"> <title>Results</title> <p>Data from 87 subjects were analyzed. MF/F with spacer demonstrated a larger change in mean FEV<sub>1</sub> AUC<sub>0–12hr</sub> versus placebo (115 vs. −9 mL), with a treatment difference of 124 mL (95% CI 94–154, <italic>P</italic> < 0.001). Similarly, MF/F without spacer versus placebo resulted in a 102 mL difference in mean‐adjusted FEV<sub>1</sub> AUC<sub>0–12hr</sub> (95% CI 73–131, <italic>P</italic> < 0.001), whereas the difference between MF/F with spacer versus MF/F without spacer was 22 mL (95% CI −8 to 52, <italic>P</italic> = 0.144). The difference between F‐DPI versus placebo was 106 mL (95% CI 77–135, <italic>P</italic> < 0.001). No unexpected adverse events were observed.</p> </sec> <sec id="ppul22850-sec-0004" sec-type="section"> <title>Conclusions</title> <p>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. <bold>Pediatr Pulmonol. 2014; 49:441–450.</bold> © 2013 Wiley Periodicals, Inc.</p> </sec> </abstract>