Although the clinical impact of small airway inflammation in asthma is not well understood, associations with nocturnal asthma symptoms, exacerbations, and airway hyperresponsiveness have been demonstrated. One measure of the effect of asthma treatments on small airway function is the change in forced expiratory flow between 25% and 75% of vital capacity (FEF25%–75%) following treatment. Changes in FEF25%–75% were determined in children with asthma using mometasone furoate delivered by a dry powder inhaler (MF-DPI), an ICS approved for administration once daily in the evening (QD PM) in patients aged ≥ 4 years.
FEF25%–75% was analyzed as a secondary variable in a randomized, placebo-controlled, double-blinded, 12-week clinical trial in children aged 4–11 years with mild to moderate persistent asthma (primary results have been presented elsewhere). Patients were previously maintained on other ICSs with no washout period before randomization. Treatments investigated were MF-DPI 100 αg QD PM (the US approved pediatric dose), MF-DPI 100 αg twice daily (BID), and placebo. FEF25%–75% was measured by spirometry and was obtained from the single curve that gave the largest sum of forced vital capacity plus forced expiratory volume in 1 second. Treatment differences were analyzed by ANOVA.
Data from 296 children were analyzed. Significant improvements in FEF25%–75% began within the first week of treatment in the MF-DPI 100 αg QD PM and 100 αg BID groups compared with the placebo group (P≤0.033). The improvements were sustained throughout the study, and ranged from 16.0% to 22.7% for MF-DPI 100 αg QD PM, 17.7% to 32.7% for MF-DPI 100 αg BID, versus 6.1% to 11.4% for placebo. The changes from baseline at endpoint were 14.0% and 24.0% for patients on MF-DPI 100 αg QD PM and MF-DPI 100 αg BID, respectively, versus 0.5% for patients on placebo.
MF-DPI significantly improved small airway function in children with asthma.
Improvements in small airway function with MF-DPI therapy may contribute to effective asthma control in children.
Michael Noonan, Grant monies (from industry related sources) Schering-Plough; Employee Schering-Plough; Consultant fee, speaker bureau, advisory committee, etc. Schering-Plough; No Product/Research Disclosure Information