Trials / Completed
CompletedNCT00756418
Montelukast Post-marketing Comparative Study With Theophyline Added to Inhaled Corticosteroid (0476-396)
A Randomized Open-Label Comparative Study of Montelukast Versus Theophylline Added to Inhaled Corticosteroid in Pediatric Patients With Bronchial Asthma
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 84 (actual)
- Sponsor
- Organon and Co · Industry
- Sex
- All
- Age
- 6 Years – 14 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | montelukast | montelukast 5 mg QD 4-weeks. |
| DRUG | Theophylline | Theophylline 100 to 200 mg BID 4-weeks. |
Timeline
- Start date
- 2003-06-01
- Primary completion
- 2004-08-28
- Completion
- 2004-08-28
- First posted
- 2008-09-22
- Last updated
- 2024-08-15
Source: ClinicalTrials.gov record NCT00756418. Inclusion in this directory is not an endorsement.