drugset / Trial / NCT00756418

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

NCT00756418

Phase 4 Completed 84 enrolled Organon and Co
RandomizedParallel-groupOpen-labelTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
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