To characterize moderate-to-severe allergic asthma and its treatment burden in children aged 6–11 years inadequately controlled with inhaled corticosteroids.
474 patient/caregiver pairs from 46 centers in the U.S. and Puerto Rico are being followed in a 2-year observational study. Key inclusion criteria: ≥ 12-month asthma history, > 200 mcg fluticasone DPI daily or equivalent (with or without additional controllers), perennial aeroallergen sensitivity, total IgE ≥ 30 IU/mL and evidence of impairment and/or risk. Data collection includes: patient and family atopic disease history; baseline aeroallergen sensitivities; co-morbid disease history; corticosteroid burden; asthma control; environment; healthcare utilization for asthma exacerbations requiring oral corticosteroids; patient/caregiver quality of life assessment; and patient/caregiver lost days of school/work.
Mean patient age (± SD) 8.7 years (1.64); 67% male; 58% caucasian and 26% black. 39% reported ≥ 1 asthma exacerbation in the 3 months prior to enrollment. Of these, 61% required treatment with an oral corticosteroid (OCS) and 13% of this subset went to the emergency room. 80% reported history of 1 or more allergic co-morbidities and 78% reported concomitant seasonal allergies. Median (interquartile range) average total daily unadjusted dose of inhaled corticosteroid in the 3 months prior to baseline was 320 (324) mcg/day. The mean (± SD) Childhood Asthma Control Test score was 19 ± 4.3.
Despite receiving asthma treatment at doses indicated by NIH guidelines (EPR3), this cohort remains symptomatic, with frequent exacerbations These children have a high incidence of allergic co-morbidities, self-reported limitations in activity and experience a suboptimal level of control. Additional treatment, control and self-reported quality of life data will be analyzed throughout the study.
This study will establish one of the largest and best characterized cohorts of school aged children with symptomatic moderate-to-severe allergic asthma. The study results will allow for a greater understanding of the disease burden and unmet needs of these children and their caregivers.
Mark Brown, Employee I am an employee of Novartis Pharmaceuticals Corporation, the funder of this study.; No Product/Research Disclosure Information