A Randomized Open-Label Comparative Study of Montelukast Versus Theophylline Added to Inhaled Corticosteroid in Pediatric Patients With Bronchial Asthma

Organon and Co0 个研究点目标入组 84 人2003年6月1日

适应症Asthma

干预措施montelukast Theophylline

概览

阶段: 4 期
干预措施: montelukast
疾病 / 适应症: Asthma
发起方: Organon and Co
入组人数: 84
主要终点: Improvement of AM PEF over first 2 Weeks
状态: 已完成
最后更新: 去年

概览研究者入排标准研究组 & 干预措施结局指标相似试验

概览

简要总结

A clinical study explores the safety and efficacy of montelukast and to compare the safety and efficacy of montelukast with those of theophylline in pediatric bronchial asthma patients when they are used in conjunction with inhaled steroids.

注册库

clinicaltrials.gov

开始日期

2003年6月1日

结束日期

2004年8月28日

最后更新

去年

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Organon and Co

责任方

Sponsor

入排标准

入选标准

•Pediatric Bronchial Asthma Patients Aged 6 To 14 Years (At The Beginning Of The Treatment Period)
•The Severity Must Be Mild, Moderate Or Severe, Persistent Bronchial Asthma
•The Patient Must Have Symptoms That Can Be Used As Efficacy Variables (Such As Repeated Coughing And Mild Or Moderate Asthma Attacks) During The Observation Period, And Must Be Using Inhaled Steroids

排除标准

•Patient Using Anti-Asthma Treatment Or Therapy Including corticosteroids Or Oral Anti-Allergic Drugs
•Patient With Complications That Will Impair The Judgment Of Efficacy Of This Drug
•Patient With Convulsive Disorders Such As Epilepsy Or Such A History
•Patient With Liver Disease, Renal Impairment, Heart Disease Or Such Other Complication