drugset / Trial / NCT00756418
Montelukast Post-marketing Comparative Study With Theophyline Added to Inhaled Corticosteroid (0476-396)
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
| 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 | — |