PURPOSE: In children, the ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) is believed to be a more sensitive measure of airway obstruction severity than individual spirometry measurements. We investigated the effect of once-daily treatment with mometasone furoate administered via a dry powder inhaler (MF-DPI) on FEV1/FVC using data from a study in asthma patients ages 4–11 years.
METHODS: FEV1 and FVC were measured during a 12-week, double-blind, placebo-controlled study of MF-DPI in 296 children previously maintained on inhaled corticosteroids. Spirometry was performed at baseline, day 4, and weeks 1, 2, 4, 8, and 12 for patients treated with MF-DPI 110 μg in the evening (QD PM), MF-DPI 110 μg twice-daily (BID), or placebo. Changes from baseline in FEV1/FVC were analyzed using analysis of covariance. We report results for MF-DPI 110 μg QD PM, the dose approved for children 4–11 years old. Primary endpoint results from this trial have been reported elsewhere.
RESULTS: MF-DPI 110 μg QD PM significantly improved FEV1/FVC as early as week 1 compared to placebo. At endpoint, the change from baseline in FEV1/FVC was 3.10% higher in the MF-DPI 110 μg QD PM group than it was in the placebo group (P=0.0048). Statistically significant differences between MF-DPI 110 μg QD PM vs placebo for changes from baseline FEV1/FVC ranged from 2.34–3.07%. Baseline FEV1/FVC was <80% in 54% (50/98) of children receiving MF-DPI 110 μg QD PM; the ratio improved by 3.29% in this group at endpoint. Overall, the improvements in FEV1/FVC paralleled the significant improvements in FEV1, which also began at week 1 and continued throughout the study. In contrast, the only significant FVC changes compared to placebo were at endpoint.
CONCLUSION: Once-daily treatment with MF-DPI significantly improved FEV1/FVC in children 4–11 years of age with asthma, indicating a reduction in the severity of airflow limitation.
CLINICAL IMPLICATIONS: For children with asthma, MF-DPI treatment can reduce the severity of airflow limitation.
DISCLOSURE: Michael Noonan, Grant monies (from industry related sources) I have been the recipient of research grants from AstraZeneca, Dey Laboratories, Genentech, GlaxoSmithKline, Novartis, Sepracor, and Schering-Plough.; Consultant fee, speaker bureau, advisory committee, etc. I served as an Advisory Board participant for Schering-Plough and AstraZeneca.; No Product/Research Disclosure Information