Allergic rhinitis (AR) is highly prevalent in children. Olopatadine, 0.6% nasal spray (olopatadine) is approved for the relief of seasonal allergic rhinitis (SAR) symptoms in children 6 years of age and older. The objective of this study is to provide a comprehensive report of all clinical studies conducted with olopatadine in children with SAR. A pooled analysis was conducted of 2 randomized, double-blind, 2-week, IRB-approved studies that compared olopatadine with placebo (1 spray/nostril twice-daily) in patients 6-11 years of age with SAR. Assessments included the reflective total nasal symptom score (rTNSS) and total ocular symptom score (rTOSS), the Pediatric Rhinoconjunctivitis Quality-of-Life Questionnaire (PRQLQ), and the Caregiver Treatment Satisfaction Questionnaire for Allergic Rhinitis (CGTSQ-AR). Safety results were reported for these studies in combination with a pediatric pharmacokinetic study. Olopatadine was superior to placebo for mean decrease in rTNSS (p = 0.0012) and rTOSS (p = 0.0094), mean decrease in overall PRQLQ score (p = 0.0003), and mean summary CGTSQ AR score (p = 0.0013); (n = 944). The most frequently reported treatment-related events in the olopatadine group were epistaxis and dysgeusia (bad taste) (n = 1,046). For SAR treatment in patients 6-11 years of age, olopatadine was superior to placebo in reducing the symptoms of SAR, improving quality of life, and satisfying caregivers. Olopatadine is a safe and effective treatment for SAR patients as young as 6 years of age and it has been demonstrated to reduce disease impact on the lives of these children and their families.
Trial registration: ClinicalTrials.gov NCT00578929.