Montelukast Post-marketing Comparative Study With Theophyline Added to Inhaled Corticosteroid (0476-396)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Open-Label Comparative Study of Montelukast Versus Theophylline Added to Inhaled Corticosteroid in Pediatric Patients With Bronchial Asthma|
- Improvement of AM PEF over first 2 Weeks [ Time Frame: Over first 2 Weeks ] [ Designated as safety issue: No ]
|Study Start Date:||June 2003|
|Study Completion Date:||August 2004|
|Primary Completion Date:||August 2004 (Final data collection date for primary outcome measure)|
montelukast 5 mg QD 4-weeks.
Other Name: MK0476
|Active Comparator: 2||
Theophylline 100 to 200 mg BID 4-weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00756418
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|