title: Olopatadine hydrochloride in children: efficacy and safety for perennial allergic rhinitis.
abstract: OBJECTIVE
  The efficacy of antihistamines in perennial allergic rhinitis in children has been evaluated in studies using active comparators, whereas placebo-controlled studies are very few. A randomized, multicenter, double-blind, parallel-group clinical study was carried out to evaluate the dose-response relationship and superiority of olopatadine hydrochloride over placebo in children aged 7 to 16 years with perennial allergic rhinitis.
  
  
  METHODS
  Subjects received twice daily treatment for two weeks with either olopatadine 2.5 mg, 5 mg or placebo after a one-week observation period. Efficacy was assessed based on the diary card score the subject (or guardian) recorded.
  
  
  RESULTS
  Of the 302 subjects randomized, two were excluded from analysis: one did not receive treatment; the other was not monitored for efficacy parameters. The remaining 300 subjects (97 in the placebo group, 103 in the olopatadine 2.5-mg group and 100 in the olopatadine 5-mg group) constituted the full analysis set (FAS) for the efficacy analysis. As a primary endpoint, the total three nasal symptom score (for sneezing, rhinorrhea and nasal congestion) at final assessment was compared with baseline or the score obtained in the observation period. The change from baseline was then tested using analysis of covariance (ANCOVA) with the baseline score as covariate. Williams' test was applied to the least squares means estimated from this ANCOVA model for each treatment group, resulting in showing the monotonicity Williams' test assumed. The total three nasal symptom score significantly improved in the 5-mg group compared with the placebo group (p = 0.019). In contrast, the 2.5-mg group did not differ statistically from the placebo group. Adverse events occurred in 33.7% (33/98 subjects) in the placebo group, 35.9% (37/103 subjects) in the 2.5-mg group and 35.0% (35/100 subjects) in the 5-mg group. There were no serious or severe adverse events.
  
  
  CONCLUSIONS
  Olopatadine hydrochloride 5 mg twice daily is an effective and safe treatment for perennial allergic rhinitis in children.
authors.affiliation: Department of Otorhinolaryngology, Nippon Medical School, Bunkyo-ku, Tokyo, Japan. ent-kimi@nms.ac.jp
authors.forename: Kimihiro
authors.initials: K
authors.lastname: Okubo
authors.forename: Minoru
authors.initials: M
authors.lastname: Okuda
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Magara
authors.forename: Kenji
authors.initials: K
authors.lastname: Kaneko
mesh_terms: D000293:Adolescent; D000465:Algorithms; D018926:Anti-Allergic Agents / Q000009:adverse effects / Q000627:therapeutic use; D002648:Child; D003990:Dibenzoxepins / Q000009:adverse effects* / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D000069605:Olopatadine Hydrochloride; D010358:Patient Participation; D010919:Placebos; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D018926:Anti-Allergic Agents; D003990:Dibenzoxepins; D010919:Placebos; D000069605:Olopatadine Hydrochloride