title: Comprehensive report of olopatadine 0.6% nasal spray as treatment for children with seasonal allergic rhinitis.
abstract: 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.
authors.affiliation: Allergy and Asthma Medical Group and Research Center, San Diego, California, USA.
authors.forename: Eli O
authors.initials: EO
authors.lastname: Meltzer
authors.forename: Michael
authors.initials: M
authors.lastname: Blaiss
authors.forename: Carol J
authors.initials: CJ
authors.lastname: Fairchild
mesh_terms: D002648:Child; D003990:Dibenzoxepins / Q000008:administration & dosage* / Q000009:adverse effects; D018450:Disease Progression; D004341:Drug Evaluation; D004408:Dysgeusia / Q000209:etiology; D004844:Epistaxis / Q000209:etiology; D005260:Female; D039563:Histamine H1 Antagonists, Non-Sedating / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D059085:Nasal Sprays; D000069605:Olopatadine Hydrochloride; D011788:Quality of Life; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy* / Q000503:physiopathology; D011795:Surveys and Questionnaires
chemical_list: D003990:Dibenzoxepins; D039563:Histamine H1 Antagonists, Non-Sedating; D059085:Nasal Sprays; D000069605:Olopatadine Hydrochloride