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Safety and efficacy of olopatadine hydrochloride nasal spray 0.6% in pediatric subjects with allergic rhinitis.
Allergy Asthma Proc. 2009 Nov-Dec; 30(6):612-23.AA

Abstract

Olopatadine (OLO) nasal spray 0.6% is indicated for treatment of seasonal allergic rhinitis (SAR) in subjects > or = 12 years of age. This study was designed to present the results of two studies that evaluated the efficacy, safety, and pharmacokinetics (PK) of OLO in children with allergic rhinitis (AR). These were multicenter, double-blind, randomized, parallel-group studies in subjects 6 to <12 years of age (study 1) and 2 to <6 years of age (study 2) with SAR (study 1) or AR (study 2). In study 1, nasal and ocular symptoms were scored for efficacy, and study 2 included PK analyses. In both studies, subjects were evaluated based on physical/nasal examinations and adverse events (AEs). Overall, 1188 subjects (study 1) and 132 subjects (study 2) were randomized, respectively. OLO (1 or 2 sprays/nostril, b.i.d.) was superior to vehicle in the percent decrease in reflective total nasal symptom scores (p < or = 0.0120). OLO 1 spray/nostril b.i.d. was also superior to vehicle in the percent decreases in reflective total ocular symptom scores (p < or = 0.0084), change from baseline in Pediatric Rhinoconjunctivitis Quality-of-Life Questionnaire scores (p < or = 0.0377), Caregiver Treatment Satisfaction Questionnaire scores (p < or = 0.0450), and proportions of subjects reporting improvements in Subject Global Assessments (p = 0.0035). The most frequently reported treatment-related events in the OLO group were bad/bitter taste and epistaxis. In subjects 6 to <12 years of age, OLO was superior to vehicle in the treatment of SAR. In subjects 2 to <12 years of age, OLO had an overall low rate of AEs and low systemic exposure.

Authors+Show Affiliations

Department of Pediatrics, Division of Allergy and Immunology, University of California, Irvine, California, USA. weberger@uci.eduNo 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

20031007

Citation

Berger, William E., et al. "Safety and Efficacy of Olopatadine Hydrochloride Nasal Spray 0.6% in Pediatric Subjects With Allergic Rhinitis." Allergy and Asthma Proceedings, vol. 30, no. 6, 2009, pp. 612-23.
Berger WE, Ratner PH, Casale TB, et al. Safety and efficacy of olopatadine hydrochloride nasal spray 0.6% in pediatric subjects with allergic rhinitis. Allergy Asthma Proc. 2009;30(6):612-23.
Berger, W. E., Ratner, P. H., Casale, T. B., Meltzer, E. O., & Wall, G. M. (2009). Safety and efficacy of olopatadine hydrochloride nasal spray 0.6% in pediatric subjects with allergic rhinitis. Allergy and Asthma Proceedings, 30(6), 612-23. https://doi.org/10.2500/aap.2009.30.3298
Berger WE, et al. Safety and Efficacy of Olopatadine Hydrochloride Nasal Spray 0.6% in Pediatric Subjects With Allergic Rhinitis. Allergy Asthma Proc. 2009;30(6):612-23. PubMed PMID: 20031007.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and efficacy of olopatadine hydrochloride nasal spray 0.6% in pediatric subjects with allergic rhinitis. AU - Berger,William E, AU - Ratner,Paul H, AU - Casale,Thomas B, AU - Meltzer,Eli O, AU - Wall,G Michael, PY - 2009/12/25/entrez PY - 2009/12/25/pubmed PY - 2010/6/10/medline SP - 612 EP - 23 JF - Allergy and asthma proceedings JO - Allergy Asthma Proc VL - 30 IS - 6 N2 - Olopatadine (OLO) nasal spray 0.6% is indicated for treatment of seasonal allergic rhinitis (SAR) in subjects > or = 12 years of age. This study was designed to present the results of two studies that evaluated the efficacy, safety, and pharmacokinetics (PK) of OLO in children with allergic rhinitis (AR). These were multicenter, double-blind, randomized, parallel-group studies in subjects 6 to <12 years of age (study 1) and 2 to <6 years of age (study 2) with SAR (study 1) or AR (study 2). In study 1, nasal and ocular symptoms were scored for efficacy, and study 2 included PK analyses. In both studies, subjects were evaluated based on physical/nasal examinations and adverse events (AEs). Overall, 1188 subjects (study 1) and 132 subjects (study 2) were randomized, respectively. OLO (1 or 2 sprays/nostril, b.i.d.) was superior to vehicle in the percent decrease in reflective total nasal symptom scores (p < or = 0.0120). OLO 1 spray/nostril b.i.d. was also superior to vehicle in the percent decreases in reflective total ocular symptom scores (p < or = 0.0084), change from baseline in Pediatric Rhinoconjunctivitis Quality-of-Life Questionnaire scores (p < or = 0.0377), Caregiver Treatment Satisfaction Questionnaire scores (p < or = 0.0450), and proportions of subjects reporting improvements in Subject Global Assessments (p = 0.0035). The most frequently reported treatment-related events in the OLO group were bad/bitter taste and epistaxis. In subjects 6 to <12 years of age, OLO was superior to vehicle in the treatment of SAR. In subjects 2 to <12 years of age, OLO had an overall low rate of AEs and low systemic exposure. SN - 1539-6304 UR - https://www.unboundmedicine.com/medline/citation/20031007/Safety_and_efficacy_of_olopatadine_hydrochloride_nasal_spray_0_6_in_pediatric_subjects_with_allergic_rhinitis_ L2 - https://www.ingentaconnect.com/openurl?genre=article&amp;issn=1088-5412&amp;volume=30&amp;issue=6&amp;spage=612&amp;aulast=Berger DB - PRIME DP - Unbound Medicine ER -