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Safety and efficacy of olopatadine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis.
Ann Allergy Asthma Immunol 2005; 95(6):600-6AA

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+Show Affiliations

Allergy and Asthma Medical Group and Research Center, San Diego, California 92123, USA. EOMELTZER@aol.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16400902

Citation

Meltzer, Eli O., et al. "Safety and Efficacy of Olopatadine Hydrochloride Nasal Spray for the Treatment of Seasonal Allergic Rhinitis." Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, vol. 95, no. 6, 2005, pp. 600-6.
Meltzer EO, Hampel FC, Ratner PH, et al. Safety and efficacy of olopatadine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2005;95(6):600-6.
Meltzer, E. O., Hampel, F. C., Ratner, P. H., Bernstein, D. I., Larsen, L. V., Berger, W. E., ... Barnes, J. R. (2005). Safety and efficacy of olopatadine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis. Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, 95(6), pp. 600-6.
Meltzer EO, et al. Safety and Efficacy of Olopatadine Hydrochloride Nasal Spray for the Treatment of Seasonal Allergic Rhinitis. Ann Allergy Asthma Immunol. 2005;95(6):600-6. PubMed PMID: 16400902.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and efficacy of olopatadine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis. AU - Meltzer,Eli O, AU - Hampel,Frank C, AU - Ratner,Paul H, AU - Bernstein,David I, AU - Larsen,Lawrence V, AU - Berger,William E, AU - Finn,Albert F,Jr AU - Marple,Bradley F, AU - Roland,Peter S, AU - Wall,G Michael, AU - Brubaker,Michael J, AU - Dimas,Carolyn, AU - Potts,Susan L, AU - Silver,Lewis H, AU - Barnes,J Rod, PY - 2006/1/13/pubmed PY - 2006/1/27/medline PY - 2006/1/13/entrez SP - 600 EP - 6 JF - Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology JO - Ann. Allergy Asthma Immunol. VL - 95 IS - 6 N2 - 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. SN - 1081-1206 UR - https://www.unboundmedicine.com/medline/citation/16400902/Safety_and_efficacy_of_olopatadine_hydrochloride_nasal_spray_for_the_treatment_of_seasonal_allergic_rhinitis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1081-1206(10)61025-3 DB - PRIME DP - Unbound Medicine ER -