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

Eli O. Meltzer; Frank C. Hampel; Paul H. Ratner; David I. Bernstein; Lawrence V. Larsen; William E. Berger; Albert F. Finn; Bradley F. Marple; Peter S. Roland; G. Michael Wall; Michael J. Brubaker; Carolyn Dimas; Susan L. Potts; Lewis H. Silver; J. Rod Barnes

doi:10.1016/S1081-1206(10)61025-3

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

Eli O. Meltzer, Frank C. Hampel, Paul H. Ratner, David I. Bernstein, Lawrence V. Larsen, William E. Berger, Albert F. Finn, Bradley F. Marple, Peter S. Roland, G. Michael Wall, Michael J. Brubaker, Carolyn Dimas, Susan L. Potts, Lewis H. Silver, J. Rod Barnes

Research output: Contribution to journal › Article › peer-review

62 Scopus citations

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.

Original language	English (US)
Pages (from-to)	600-606
Number of pages	7
Journal	Annals of Allergy, Asthma and Immunology
Volume	95
Issue number	6
DOIs	https://doi.org/10.1016/S1081-1206(10)61025-3
State	Published - Dec 2005

ASJC Scopus subject areas

Immunology and Allergy
Immunology
Pulmonary and Respiratory Medicine

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10.1016/S1081-1206(10)61025-3

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Meltzer, E. O., Hampel, F. C., Ratner, P. H., Bernstein, D. I., Larsen, L. V., Berger, W. E., Finn, A. F., Marple, B. F., Roland, P. S., Wall, G. M., Brubaker, M. J., Dimas, C., Potts, S. L., Silver, L. H., & Barnes, J. R. (2005). Safety and efficacy of olopatadine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis. Annals of Allergy, Asthma and Immunology, 95(6), 600-606. https://doi.org/10.1016/S1081-1206(10)61025-3

Meltzer, EO, Hampel, FC, Ratner, PH, Bernstein, DI, Larsen, LV, Berger, WE, Finn, AF, Marple, BF, Roland, PS, Wall, GM, Brubaker, MJ, Dimas, C, Potts, SL, Silver, LH & Barnes, JR 2005, 'Safety and efficacy of olopatadine hydrochloride nasal spray for the treatment of seasonal allergic rhinitis', Annals of Allergy, Asthma and Immunology, vol. 95, no. 6, pp. 600-606. https://doi.org/10.1016/S1081-1206(10)61025-3

@article{f4e1192500ff435abef5f6ef201a4dca,

title = "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.",

author = "Meltzer, {Eli O.} and Hampel, {Frank C.} and Ratner, {Paul H.} and Bernstein, {David I.} and Larsen, {Lawrence V.} and Berger, {William E.} and Finn, {Albert F.} and Marple, {Bradley F.} and Roland, {Peter S.} and Wall, {G. Michael} and Brubaker, {Michael J.} and Carolyn Dimas and Potts, {Susan L.} and Silver, {Lewis H.} and Barnes, {J. Rod}",

note = "Funding Information: a Allergy and Asthma Medical Group and Research Center, San Diego, California. b Division of Immunology and Allergy, Department of Pediatrics, University of California, San Diego, California. c Central Texas Health Research, New Braunfels and San Antonio, Texas. d Sylvana Research, San Antonio, Texas. e Bernstein Clinical Research Center, Cincinnati, Ohio. fDivision of Immunology, Department of Clinical Medicine, University of Cincinnati, Cincinnati, Ohio. g Intermountain Clinical Research, Salt Lake City, Utah. h Southern California Research, Mission Viejo, California. iDivision of Allergy and Immunology, Department of Pediatrics, University of California, Irvine, California. j Department of Family Medicine, Internal Medicine, Microbiology, and Immunology, Medical University of South Carolina, Charleston, South Carolina. k Department of Otolaryngology–Head and Neck Surgery, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas. l Alcon Research Ltd, Fort Worth, Texas. This study was supported by Alcon Research Ltd. Dr Marple served as a consultant to and Dr Roland served as medical monitor to Alcon on this trial. Received for publication May 27, 2004. Accepted for publication in revised form March 15, 2005.",

year = "2005",

month = dec,

doi = "10.1016/S1081-1206(10)61025-3",

language = "English (US)",

volume = "95",

pages = "600--606",

journal = "Annals of Allergy, Asthma and Immunology",

issn = "1081-1206",

publisher = "American College of Allergy, Asthma and Immunology",

number = "6",

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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.

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

N1 - Funding Information: a Allergy and Asthma Medical Group and Research Center, San Diego, California. b Division of Immunology and Allergy, Department of Pediatrics, University of California, San Diego, California. c Central Texas Health Research, New Braunfels and San Antonio, Texas. d Sylvana Research, San Antonio, Texas. e Bernstein Clinical Research Center, Cincinnati, Ohio. fDivision of Immunology, Department of Clinical Medicine, University of Cincinnati, Cincinnati, Ohio. g Intermountain Clinical Research, Salt Lake City, Utah. h Southern California Research, Mission Viejo, California. iDivision of Allergy and Immunology, Department of Pediatrics, University of California, Irvine, California. j Department of Family Medicine, Internal Medicine, Microbiology, and Immunology, Medical University of South Carolina, Charleston, South Carolina. k Department of Otolaryngology–Head and Neck Surgery, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas. l Alcon Research Ltd, Fort Worth, Texas. This study was supported by Alcon Research Ltd. Dr Marple served as a consultant to and Dr Roland served as medical monitor to Alcon on this trial. Received for publication May 27, 2004. Accepted for publication in revised form March 15, 2005.

PY - 2005/12

Y1 - 2005/12

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.

AB - 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.

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

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