当前位置： SCI文献检索 > CLINICAL THERAPEUTICS期刊下所有文献 > Effectiveness and tolerability of zafirlukast for the treatment of asthma in children.

Effectiveness and tolerability of zafirlukast for the treatment of asthma in children.

Abstract：

OBJECTIVE:This study was undertaken to examine the dose-response relationship of zafirlukast (5 to 40 mg BID) and to assess the efficacy and tolerability of the 10-mg BID dose in school-aged children with mild to moderate asthma. BACKGROUND:The efficacy and tolerability of zafirlukast, an oral leukotriene-receptor antagonist, has been demonstrated in adolescents and adults aged > or = 12 years. METHODS:Data from 2 placebo-controlled, parallel-group, multicenter trials (trial 1, 4-week double-blind; trial 2, 6-week double-blind) were integrated. Children aged 5 to 11 years were randomly assigned to receive zafirlukast 5 mg BID (n = 99), 10 mg BID (n = 205), 20 mg BID (n = 105), 40 mg BID (n = 99), or placebo (n = 206). The primary outcome was change from baseline in forced expiratory volume in 1 second (FEV1) expressed as percent of predicted normal. Secondary outcomes were FEV1 (L), morning and evening peak expiratory flow, peak flow variability, short-acting beta2-agonist use, asthma episode score, and nights awakened by asthma. RESULTS:Mean baseline FEV1 was 76.5% of predicted. The greatest improvements were generally seen with zafirlukast 5 mg BID or 10 mg BID, with no additional clinically significant benefits seen at higher doses. The pooled data analysis showed that 10 mg BID compared with placebo significantly improved (P < 0.045) all efficacy outcomes except asthma-episode score and nights awakened with asthma. However, in the subset of children who had > or = 1 night awakened per week at baseline (zafirlukast 10 mg BID = 78; placebo = 86), 10 mg BID significantly reduced nights awakened (P = 0.009) (mean difference from placebo at end point = -0.81 night/wk). All zafirlukast doses were well tolerated and had tolerability profiles that were clinically indistinguishable from placebo. CONCLUSION:These results support the effectiveness and tolerability of the 10-mg BID dose of zafirlukast for the prophylaxis and chronic treatment of mild to moderate asthma in children.

journal_name

Clin Ther

journal_title

Clinical therapeutics

authors

Pearlman DS,Lampl KL,Dowling PJ Jr,Miller CJ,Bonuccelli CM

doi

10.1016/S0149-2918(00)90007-9

subject

Has Abstract

pub_date

2000-06-01 00:00:00

pages

732-47

issue

eissn

0149-2918

issn

1879-114X

pii

S0149-2918(00)90007-9

journal_volume

pub_type

临床试验,杂志文章,多中心研究

在线工具

Effectiveness and tolerability of zafirlukast for the treatment of asthma in children.