Abstract
Methods Participants aged 5 to 17 years of age, with at least a 1year history of HDM-associated AR requiring regular intake of symptomatic treatment, a positive skin prick test to HDM, HDM-specific serum IgE ≥0.7 kU/L, and an Average Rhinitis Total Symptom Score (ARTSS, scale: 0-12) ≥5 during a 7-day screening period were randomized (1:1) to receive 300IR or placebo tablets once daily for a year. Participants recorded their rhinitis symptoms and use of rescue medication. The primary efficacy endpoint, Average Adjusted Symptom Score (AAdSS), which adjusts symptom score for rescue medication use, was assessed over the last 2 months of the treatment period and analyzed by ANCOVA.
Highlights
The efficacy and safety of 500IR and 300IR sublingual tablets of house dust mite (HDM) allergen extracts have been demonstrated in adults with HDM-related allergic rhinitis (AR)
The most commonly reported adverse events (AEs) were application site reactions, consistent with the safety profile observed in adults
In this study, participants were insufficiently symptomatic to enable evaluation of the efficacy of the HDM sublingual tablet. This suggests that, for clinical research purposes, inclusion of children with HDM-driven AR based on selfassessments of symptom severity and positive skin or in-vitro testing is inadequate
Summary
The efficacy and safety of 500IR and 300IR sublingual tablets of house dust mite (HDM) allergen extracts have been demonstrated in adults with HDM-related allergic rhinitis (AR). We report the efficacy and safety of the 300IR dose in a double-blind, placebo-controlled study in children and adolescents
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