当前位置： SCI文献检索 > CURRENT MEDICAL RESEARCH AND OPINION期刊下所有文献 > Olopatadine hydrochloride in children: efficacy and safety for perennial allergic rhinitis.

Olopatadine hydrochloride in children: efficacy and safety for perennial allergic rhinitis.

Abstract：

OBJECTIVE:The efficacy of antihistamines in perennial allergic rhinitis in children has been evaluated in studies using active comparators, whereas placebo-controlled studies are very few. A randomized, multicenter, double-blind, parallel-group clinical study was carried out to evaluate the dose-response relationship and superiority of olopatadine hydrochloride over placebo in children aged 7 to 16 years with perennial allergic rhinitis. METHODS:Subjects received twice daily treatment for two weeks with either olopatadine 2.5 mg, 5 mg or placebo after a one-week observation period. Efficacy was assessed based on the diary card score the subject (or guardian) recorded. RESULTS:Of the 302 subjects randomized, two were excluded from analysis: one did not receive treatment; the other was not monitored for efficacy parameters. The remaining 300 subjects (97 in the placebo group, 103 in the olopatadine 2.5-mg group and 100 in the olopatadine 5-mg group) constituted the full analysis set (FAS) for the efficacy analysis. As a primary endpoint, the total three nasal symptom score (for sneezing, rhinorrhea and nasal congestion) at final assessment was compared with baseline or the score obtained in the observation period. The change from baseline was then tested using analysis of covariance (ANCOVA) with the baseline score as covariate. Williams' test was applied to the least squares means estimated from this ANCOVA model for each treatment group, resulting in showing the monotonicity Williams' test assumed. The total three nasal symptom score significantly improved in the 5-mg group compared with the placebo group (p = 0.019). In contrast, the 2.5-mg group did not differ statistically from the placebo group. Adverse events occurred in 33.7% (33/98 subjects) in the placebo group, 35.9% (37/103 subjects) in the 2.5-mg group and 35.0% (35/100 subjects) in the 5-mg group. There were no serious or severe adverse events. CONCLUSIONS:Olopatadine hydrochloride 5 mg twice daily is an effective and safe treatment for perennial allergic rhinitis in children.

journal_name

Curr Med Res Opin

journal_title

Current medical research and opinion

authors

Okubo K,Okuda M,Magara H,Kaneko K

doi

10.1185/03007995.2010.485413

subject

Has Abstract

pub_date

2010-07-01 00:00:00

pages

1657-65

issue

eissn

0300-7995

issn

1473-4877

journal_volume

pub_type

杂志文章,多中心研究,随机对照试验

在线工具

Olopatadine hydrochloride in children: efficacy and safety for perennial allergic rhinitis.