Safety and efficacy of olopatadine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis.

A nasal spray containing the antiallergy agent olopatadine hydrochloride is being developed for the treatment of seasonal allergic rhinitis (SAR).
To evaluate the safety and efficacy of 2 concentrations of olopatadine nasal spray vs placebo in patients with SAR.
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).
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.
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.
AuthorsEli O Meltzer, Frank C Hampel, Paul H Ratner, David I Bernstein, Lawrence V Larsen, William E Berger, Albert F Finn Jr, Bradley F Marple, Peter S Roland, G Michael Wall, Michael J Brubaker, Carolyn Dimas, Susan L Potts, Lewis H Silver, J Rod Barnes
JournalAnnals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology (Ann Allergy Asthma Immunol) Vol. 95 Issue 6 Pg. 600-6 (Dec 2005) ISSN: 1081-1206 [Print] United States
PMID16400902 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Anti-Allergic Agents
  • Dibenzoxepins
  • Histamine H1 Antagonists
  • Olopatadine Hydrochloride
  • Administration, Intranasal
  • Adolescent
  • Adult
  • Aged
  • Anti-Allergic Agents (administration & dosage, adverse effects, therapeutic use)
  • Child
  • Dibenzoxepins (administration & dosage, adverse effects, therapeutic use)
  • Double-Blind Method
  • Female
  • Histamine H1 Antagonists (administration & dosage, adverse effects, therapeutic use)
  • Humans
  • Male
  • Middle Aged
  • Olopatadine Hydrochloride
  • Quality of Life
  • Surveys and Questionnaires
  • Treatment Outcome

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