Montelukast Post-marketing Comparative Study With Theophyline Added to Inhaled Corticosteroid (0476-396)

Summary

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.

Timeline

Start

2003-06-01

Primary completion

2004-08-28

Completion

2004-08-28

Outcome

Met primary endpoint

paper A significant increase in morning PEF was observed in the add-on montelukast group as compared with the add-on theophylline group at Week 2 PMID 17075269 ↗

paper montelukast group as compared with the add-on theophylline group at Week 2 (change from baseline of 22.8 L/minvs. 8.7 L/min; p = 0.041 PMID 17075269 ↗

Publications

• Results Kondo N, Katsunuma T, Odajima Y, Morikawa A. A randomized open-label comparative study of montelukast versus theophylline added to inhaled corticosteroid in asthmatic children. Allergol Int. 2006 Sep;55(3):287-93. doi: 10.2332/allergolint.55.287.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Montelukast	Other / unclassified	5 mg	—
Comparator	Theophylline	Small molecule	5 mg/kg	—
Comparator	Theophylline	Small molecule	8 mg/kg	—
Comparator	Theophylline	Small molecule	100 mg	—
Comparator	Theophylline	Small molecule	200 mg	—

Indications