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Safety and efficacy of olopatadine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis to mountain cedar.
Ann Allergy Asthma Immunol. 2005 Nov; 95(5):474-9.AA

Abstract

BACKGROUND

A nasal spray containing the antiallergy agent olopatadine hydrochloride is being developed for the treatment of seasonal allergic rhinitis (SAR) to mountain cedar.

OBJECTIVE

To evaluate the safety and efficacy of 2 concentrations of olopatadine nasal spray vs placebo nasal spray in patients with SAR to mountain cedar.

METHODS

This was a multicenter, randomized, double-blind, placebo-controlled study. After a 3- to 21-day placebo run-in, 677 patients aged 12 to 81 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.

RESULTS

Olopatadine spray (0.4% and 0.6%) was statistically significantly superior to placebo for percentage change from baseline in overall reflective and instantaneous TNSSs. Also, 0.6% olopatadine was statistically significantly superior to placebo for reducing the reflective and instantaneous assessments of sneezing, runny nose, itchy nose, stuffy nose, itchy eyes, and watery eyes. 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 and individual symptoms, including congestion, itchy and runny nose, sneezing, and itchy and watery eyes, in patients with SAR to mountain cedar. Olopatadine nasal spray administered twice daily was safe and well tolerated in adolescents and adults.

Authors+Show Affiliations

Sylvana Research, San Antonio, Texas 78229, USA. phratner@swbell.netNo 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

16312171

Citation

Ratner, Paul H., et al. "Safety and Efficacy of Olopatadine Hydrochloride Nasal Spray for the Treatment of Seasonal Allergic Rhinitis to Mountain Cedar." Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, vol. 95, no. 5, 2005, pp. 474-9.
Ratner PH, Hampel FC, Amar NJ, et al. Safety and efficacy of olopatadine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis to mountain cedar. Ann Allergy Asthma Immunol. 2005;95(5):474-9.
Ratner, P. H., Hampel, F. C., Amar, N. J., van Bavel, J. H., Mohar, D., Marple, B. F., Roland, P. S., Wall, G. M., Brubaker, M. J., Drake, M., Turner, D., & Silver, L. H. (2005). Safety and efficacy of olopatadine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis to mountain cedar. Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, 95(5), 474-9.
Ratner PH, et al. Safety and Efficacy of Olopatadine Hydrochloride Nasal Spray for the Treatment of Seasonal Allergic Rhinitis to Mountain Cedar. Ann Allergy Asthma Immunol. 2005;95(5):474-9. PubMed PMID: 16312171.
* 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 to mountain cedar. AU - Ratner,Paul H, AU - Hampel,Frank C, AU - Amar,Niran J, AU - van Bavel,Julius H, AU - Mohar,Dale, AU - Marple,Bradley F, AU - Roland,Peter S, AU - Wall,G Michael, AU - Brubaker,Michael J, AU - Drake,Margaret, AU - Turner,Darell, AU - Silver,Lewis H, PY - 2005/11/30/pubmed PY - 2005/12/21/medline PY - 2005/11/30/entrez SP - 474 EP - 9 JF - Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology JO - Ann Allergy Asthma Immunol VL - 95 IS - 5 N2 - BACKGROUND: A nasal spray containing the antiallergy agent olopatadine hydrochloride is being developed for the treatment of seasonal allergic rhinitis (SAR) to mountain cedar. OBJECTIVE: To evaluate the safety and efficacy of 2 concentrations of olopatadine nasal spray vs placebo nasal spray in patients with SAR to mountain cedar. METHODS: This was a multicenter, randomized, double-blind, placebo-controlled study. After a 3- to 21-day placebo run-in, 677 patients aged 12 to 81 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. RESULTS: Olopatadine spray (0.4% and 0.6%) was statistically significantly superior to placebo for percentage change from baseline in overall reflective and instantaneous TNSSs. Also, 0.6% olopatadine was statistically significantly superior to placebo for reducing the reflective and instantaneous assessments of sneezing, runny nose, itchy nose, stuffy nose, itchy eyes, and watery eyes. 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 and individual symptoms, including congestion, itchy and runny nose, sneezing, and itchy and watery eyes, in patients with SAR to mountain cedar. 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/16312171/Safety_and_efficacy_of_olopatadine_hydrochloride_nasal_spray_for_the_treatment_of_seasonal_allergic_rhinitis_to_mountain_cedar_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1081-1206(10)61174-X DB - PRIME DP - Unbound Medicine ER -