PMID- 20031007
OWN - NLM
STAT- MEDLINE
DCOM- 20100609
LR  - 20161020
IS  - 1539-6304 (Electronic)
IS  - 1088-5412 (Linking)
VI  - 30
IP  - 6
DP  - 2009 Nov-Dec
TI  - Safety and efficacy of olopatadine hydrochloride nasal spray 0.6% in pediatric 
      subjects with allergic rhinitis.
PG  - 612-23
LID - 10.2500/aap.2009.30.3298 [doi]
AB  - 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.
FAU - Berger, William E
AU  - Berger WE
AD  - Department of Pediatrics, Division of Allergy and Immunology, University of 
      California, Irvine, California, USA. weberger@uci.edu
FAU - Ratner, Paul H
AU  - Ratner PH
FAU - Casale, Thomas B
AU  - Casale TB
FAU - Meltzer, Eli O
AU  - Meltzer EO
FAU - Wall, G Michael
AU  - Wall GM
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Allergy Asthma Proc
JT  - Allergy and asthma proceedings
JID - 9603640
RN  - 0 (Dibenzoxepins)
RN  - 0 (Histamine H1 Antagonists, Non-Sedating)
RN  - 2XG66W44KF (Olopatadine Hydrochloride)
SB  - IM
MH  - Administration, Intranasal
MH  - Child
MH  - Child, Preschool
MH  - Conjunctivitis, Allergic/drug therapy
MH  - *Dibenzoxepins/administration & dosage/adverse effects/pharmacokinetics
MH  - Epistaxis/etiology/prevention & control
MH  - Female
MH  - *Histamine H1 Antagonists, Non-Sedating/administration & dosage/adverse 
      effects/pharmacokinetics
MH  - Humans
MH  - Male
MH  - Nasal Obstruction/drug therapy
MH  - Olopatadine Hydrochloride
MH  - Quality of Life
MH  - Rhinitis, Allergic, Seasonal/*drug therapy/physiopathology/psychology
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
EDAT- 2009/12/25 06:00
MHDA- 2010/06/10 06:00
CRDT- 2009/12/25 06:00
PHST- 2009/12/25 06:00 [entrez]
PHST- 2009/12/25 06:00 [pubmed]
PHST- 2010/06/10 06:00 [medline]
AID - 10.2500/aap.2009.30.3298 [doi]
PST - ppublish
SO  - Allergy Asthma Proc. 2009 Nov-Dec;30(6):612-23. doi: 10.2500/aap.2009.30.3298.