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ABSTRACT: Background
The efficacy and safety of 300 index of reactivity (IR) tablets of house dust mite (HDM) allergen extracts in Japanese pediatric (5-16 years old) patients with allergic rhinitis (AR) were assessed in a double-blind, randomized, placebo-controlled study (JAPIC CTI-152981).Methods
Patients were randomized 1:1 to HDM sublingual tablets or placebo once daily for 52 weeks. The primary end-point was average adjusted symptom score (AASS; average of daily Rhinitis Total Symptom Scores, comprising sneezing, rhinorrhea, nasal congestion, and nasal pruritus, adjusted for rescue medication use), analyzed during Weeks 48-52 (mixed-effects model for repeated measures).Results
Of 438 patients randomized, 403 (92%; 193 active, 210 placebo) completed the study. AASS (leas
SUBMITTER: Okamoto Y
PROVIDER: S-EPMC7379546 | biostudies-literature | 2019 Feb
REPOSITORIES: biostudies-literature