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: Eli 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
• Journal: Annals 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
• PMID: 16400902 (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

Topics

• 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