title: Safety and efficacy of olopatadine hydrochloride nasal spray 0.6% in pediatric subjects with allergic rhinitis.
abstract: Olopatadine (OLO) nasal spray 0.6% is indicated for treatment of seasonal allergic rhinitis (SAR) in subjects > or = 12 years of age. This study was designed to present the results of two studies that evaluated the efficacy, safety, and pharmacokinetics (PK) of OLO in children with allergic rhinitis (AR). These were multicenter, double-blind, randomized, parallel-group studies in subjects 6 to <12 years of age (study 1) and 2 to <6 years of age (study 2) with SAR (study 1) or AR (study 2). In study 1, nasal and ocular symptoms were scored for efficacy, and study 2 included PK analyses. In both studies, subjects were evaluated based on physical/nasal examinations and adverse events (AEs). Overall, 1188 subjects (study 1) and 132 subjects (study 2) were randomized, respectively. OLO (1 or 2 sprays/nostril, b.i.d.) was superior to vehicle in the percent decrease in reflective total nasal symptom scores (p < or = 0.0120). OLO 1 spray/nostril b.i.d. was also superior to vehicle in the percent decreases in reflective total ocular symptom scores (p < or = 0.0084), change from baseline in Pediatric Rhinoconjunctivitis Quality-of-Life Questionnaire scores (p < or = 0.0377), Caregiver Treatment Satisfaction Questionnaire scores (p < or = 0.0450), and proportions of subjects reporting improvements in Subject Global Assessments (p = 0.0035). The most frequently reported treatment-related events in the OLO group were bad/bitter taste and epistaxis. In subjects 6 to <12 years of age, OLO was superior to vehicle in the treatment of SAR. In subjects 2 to <12 years of age, OLO had an overall low rate of AEs and low systemic exposure.
authors.affiliation: Department of Pediatrics, Division of Allergy and Immunology, University of California, Irvine, California, USA. weberger@uci.edu
authors.forename: William E
authors.initials: WE
authors.lastname: Berger
authors.forename: Paul H
authors.initials: PH
authors.lastname: Ratner
authors.forename: Thomas B
authors.initials: TB
authors.lastname: Casale
authors.forename: Eli O
authors.initials: EO
authors.lastname: Meltzer
authors.forename: G Michael
authors.initials: GM
authors.lastname: Wall
mesh_terms: D000281:Administration, Intranasal; D002648:Child; D002675:Child, Preschool; D003233:Conjunctivitis, Allergic / Q000188:drug therapy; D003990:Dibenzoxepins / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D004844:Epistaxis / Q000209:etiology / Q000517:prevention & control; D005260:Female; D039563:Histamine H1 Antagonists, Non-Sedating / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D006801:Humans; D008297:Male; D015508:Nasal Obstruction / Q000188:drug therapy; D000069605:Olopatadine Hydrochloride; D011788:Quality of Life; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D003990:Dibenzoxepins; D039563:Histamine H1 Antagonists, Non-Sedating; D000069605:Olopatadine Hydrochloride