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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00756418 |
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.
Condition | Intervention | Phase |
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Asthma |
Drug: montelukast Drug: Theophylline |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Open-Label Comparative Study of Montelukast Versus Theophylline Added to Inhaled Corticosteroid in Pediatric Patients With Bronchial Asthma |
Enrollment: | 84 |
Study Start Date: | June 2003 |
Primary Completion Date: | August 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: montelukast
montelukast 5 mg QD 4-weeks.
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2: Active Comparator |
Drug: Theophylline
Theophylline 100 to 200 mg BID 4-weeks.
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Ages Eligible for Study: | 6 Years to 14 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2008_027, MK0476-396 |
Study First Received: | September 19, 2008 |
Last Updated: | September 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00756418 History of Changes |
Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Vasodilator Agents Bronchial Diseases Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Asthma Anti-Asthmatic Agents Cardiovascular Agents Hormones Leukotriene Antagonists Montelukast |
Lung Diseases, Obstructive Hypersensitivity Phosphodiesterase Inhibitors Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity Theophylline |
Respiratory System Agents Vasodilator Agents Bronchial Diseases Molecular Mechanisms of Pharmacological Action Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Leukotriene Antagonists Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Therapeutic Uses Immune System Diseases Asthma |
Anti-Asthmatic Agents Enzyme Inhibitors Cardiovascular Agents Pharmacologic Actions Montelukast Phosphodiesterase Inhibitors Autonomic Agents Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Theophylline Respiratory Hypersensitivity |