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.