PURPOSE: Children with sub-optimally controlled asthma may experience limitations in their ability to participate in physical activities. Clinical trial data were used to characterize the effect of mometasone furoate (MF) 100μg (delivered via dry powder inhaler) on physical function in children with persistent asthma.
METHODS: An analysis of data from 3 randomized, double-blind, placebo-controlled, 12-week studies was conducted to investigate the efficacy of MF=100μg administered once-daily (QD) in the morning (AM) or evening (PM) in children (4-11yrs). MF is currently approved for QD PM administration. In study C/197-300, MF=100μg was administered in the AM and in study P01431, in the PM; for both studies, treatment followed a 1−2-week run-in (no washout) with previously prescribed ICS. In study C97-380, MF=100μg was administered in the AM following a 2-week run-in (no washout) with beclomethasone dipropionate 168μg twice-daily. Physical function was assessed using the “Physical-Summary” and “Physical-Functioning and Role-Physical” domains of the validated Child-Health Questionnaire (CHQ-PF28), and the “Disability” domain of an asthma-specific module (higher scores=decreased disease burden). ANOVA with treatment and center was used to analyze changes from baseline to end of study treatment.
RESULTS: MF=100μg yielded statistically significant improvements from baseline over placebo, respectively, for most physical function scores despite patients having previously received ICS therapy: study C/197-300: CHQ-PF28 Physical Summary (n=116; 3.2 vs −3.2; P<0.01), CHQ-PF28 Role Physical (n=120; 6.5 vs −8.1; P<0.01), and asthma-specific module Disability (n=121; 6.0 vs −4.1; P<0.01); study P01431: CHQ-PF28 Physical Summary (n=190; 3.4 vs −2.1; P=0.002), CHQ-PF28 Physical Functioning (n=190; 6.5 vs −4.5, respectively; P=0.005), and asthma-specific module Disability (n=194; 9.2 vs 0.3; P<0.01). In study C97-380, all variables were numerically better but not statistically significant for MF=100μg compared with placebo.
CONCLUSION: Results of these 3 clinical trials indicate that asthmatic children may experience physical activity improvements following MF=100μg QD treatment relative to placebo.
CLINICAL IMPLICATIONS: For children aged 4-11 years previously maintained on ICSs, MF=100μg QD treatment improves their ability to participate in physical activities.
DISCLOSURE: William Berger, Grant monies (from industry related sources) Dr. Berger has received research grants from the following companies: Alcon, Altana, Apieron, AstraZeneca, Dey, Genentech, GlaxoSmithKline, Medpointe, Novartis, Sanofi-Aventis, Schering-Plough, Sepracor, and Teva.Dr. Weinstein has received grants from Schering-Plough, Merck, GSK, Amgen, and Novartis, served on Advisory Boards for GSK, Schering-Plough, and Sepracor and participated in Speaker’s Bureaus for Teva, Schering-Plough, Merck, Sanofi-Aventis, and Astra-Zeneca.Dr. Meltzer received research/grant support and served as a consultant and on speaker bureau for Schering-Plough.; Employee Dr. Teper is a full-time Employee of Merck Research LaboratoriesDr. Moreno-Cantu is a full-time Employee of Merck & Company; Consultant fee, speaker bureau, advisory committee, etc. Dr. Berger has served as a consultant, participated in Advisory Boards and Speaker’s Bureaus, and has been the recipient of honoraria for the following companies: Alcon, Altana, Apieron, AstraZeneca, Dey, Genentech, GlaxoSmithKline, Medpointe, Novartis, Sanofi-Aventis, Schering-Plough, Sepracor, and Teva.; No Product/Research Disclosure Information