Montelukast Post-marketing Comparative Study With Theophyline Added to Inhaled Corticosteroid (0476-396)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00756418|
Recruitment Status : Completed
First Posted : September 22, 2008
Last Update Posted : September 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: montelukast Drug: Theophylline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Open-Label Comparative Study of Montelukast Versus Theophylline Added to Inhaled Corticosteroid in Pediatric Patients With Bronchial Asthma|
|Actual Study Start Date :||June 1, 2003|
|Actual Primary Completion Date :||August 28, 2004|
|Actual Study Completion Date :||August 28, 2004|
montelukast 5 mg QD 4-weeks.
Other Name: MK0476
|Active Comparator: 2||
Theophylline 100 to 200 mg BID 4-weeks.
- Improvement of AM PEF over first 2 Weeks [ Time Frame: Over first 2 Weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00756418
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|