title: Safety and efficacy of olopatadine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis.
abstract: BACKGROUND
  A nasal spray containing the antiallergy agent olopatadine hydrochloride is being developed for the treatment of seasonal allergic rhinitis (SAR).
  
  
  OBJECTIVE
  To evaluate the safety and efficacy of 2 concentrations of olopatadine nasal spray vs placebo in patients with SAR.
  
  
  METHODS
  This was a multicenter, randomized, double-blind, placebo-controlled study. After a 3- to 21-day placebo run-in, 565 patients aged 12 to 80 years were randomized to receive 0.4% or 0.6% olopatadine or placebo, 2 sprays per nostril twice daily for 2 weeks. Patients evaluated morning and evening reflective and instantaneous nasal symptoms (sneezing, stuffy nose, runny nose, and itchy nose, which compose the total nasal symptom score [TNSS]) and ocular symptoms and completed the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).
  
  
  RESULTS
  Olopatadine spray (0.4% and 0.6%) was significantly superior to placebo for percentage change from baseline in overall reflective (P = .004 and P < .001, respectively) and instantaneous (P = .02 and P = .003, respectively) TNSSs. Also, 0.6% olopatadine was significantly superior to placebo for reducing the reflective and instantaneous assessments of sneezing, runny and itchy nose, and itchy eyes; the instantaneous assessments of watery eyes; and the overall and all 7 domain scores of the RQLQ (P < .05). Olopatadine spray exhibited a safety profile comparable with that of placebo.
  
  
  CONCLUSIONS
  Olopatadine nasal spray (0.4% and 0.6%) provided statistically significant improvements in allergic rhinitis symptoms compared with placebo regarding TNSSs (reflective and instantaneous) and in quality-of-life variables in patients with SAR. Olopatadine nasal spray administered twice daily was safe and well tolerated in adolescents and adults.
authors.affiliation: Allergy and Asthma Medical Group and Research Center, San Diego, California 92123, USA. EOMELTZER@aol.com
authors.forename: Eli O
authors.initials: EO
authors.lastname: Meltzer
authors.forename: Frank C
authors.initials: FC
authors.lastname: Hampel
authors.forename: Paul H
authors.initials: PH
authors.lastname: Ratner
authors.forename: David I
authors.initials: DI
authors.lastname: Bernstein
authors.forename: Lawrence V
authors.initials: LV
authors.lastname: Larsen
authors.forename: William E
authors.initials: WE
authors.lastname: Berger
authors.forename: Albert F
authors.initials: AF
authors.lastname: Finn
authors.forename: Bradley F
authors.initials: BF
authors.lastname: Marple
authors.forename: Peter S
authors.initials: PS
authors.lastname: Roland
authors.forename: G Michael
authors.initials: GM
authors.lastname: Wall
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Brubaker
authors.forename: Carolyn
authors.initials: C
authors.lastname: Dimas
authors.forename: Susan L
authors.initials: SL
authors.lastname: Potts
authors.forename: Lewis H
authors.initials: LH
authors.lastname: Silver
authors.forename: J Rod
authors.initials: JR
authors.lastname: Barnes
mesh_terms: D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000368:Aged; D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D002648:Child; D003990:Dibenzoxepins / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006634:Histamine H1 Antagonists / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D000069605:Olopatadine Hydrochloride; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D018926:Anti-Allergic Agents; D003990:Dibenzoxepins; D006634:Histamine H1 Antagonists; D000069605:Olopatadine Hydrochloride