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.
N1 - Funding Information:
* Sylvana Research, San Antonio, Texas. † Central Texas Health Research, New Braunfels and San Antonio, Texas. ‡ Allergy and Asthma Center, Waco, Texas. § Allergy and Asthma Associates, Austin, Texas. ¶ Kerrville Allergy and Asthma, Kerrville, Texas. ‖ Department of Otolaryngology–Head and Neck Surgery, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas. # Alcon Research Ltd, Fort Worth, Texas. This study was supported by Alcon Research Ltd. This study was presented in part as a poster at the 60th AAAAI Annual Meeting; March 22, 2004; San Francisco, CA. Dr Marple served as a consultant to and Dr Roland served as medical monitor to Alcon on this trial. Received for publication August 31, 2004. Accepted for publication in revised form February 15, 2005.
Copyright:
Copyright 2017 Elsevier B.V., All rights reserved.
PY - 2005/11
Y1 - 2005/11
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.
AB - 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.
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U2 - 10.1016/S1081-1206(10)61174-X
DO - 10.1016/S1081-1206(10)61174-X
M3 - Article
C2 - 16312171
AN - SCOPUS:28044463620
SN - 1081-1206
VL - 95
SP - 474
EP - 479
JO - Annals of Allergy, Asthma and Immunology
JF - Annals of Allergy, Asthma and Immunology
IS - 5
ER -