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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00641472 |
A one year study comparing the safety and effectiveness of Pulmicort (0.5mg strength given once a day in the evening) with either 4 or 5mg strength SINGULAR (given once a day in the evening) in children with asthma aged 2 to 8. If allocated to SINGULAR treatment, children aged between 2 and 5 will receive 4mg strength SINGULAR and those aged between 6 and 8 will receive 5mg strength SINGULAR.
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: Budesonide inhalation suspension Drug: Montelukast Sodium |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | An Evaluation of the Effectiveness of Pulmicort Respules (Budesonide Inhalation Suspension) Versus SINGULAIR (Montelukast Sodium) in Children 2-8 Years Old With Asthma Requiring Controller Therapy. |
Estimated Enrollment: | 380 |
Study Start Date: | October 2002 |
Study Completion Date: | February 2005 |
Primary Completion Date: | February 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Budesonide inhalation suspension
|
Drug: Budesonide inhalation suspension
0.5mg
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2: Active Comparator
Montelukast sodium
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Drug: Montelukast Sodium
4mg or 5mg
|
Ages Eligible for Study: | 2 Years to 8 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | ( Lars-Göran Carlsson ) |
Study ID Numbers: | DX-RES-2103, D5257L00750 |
Study First Received: | March 18, 2008 |
Last Updated: | March 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00641472 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Asthma Pulmicort Children paediatrics budesonide |
Anti-Inflammatory Agents Bronchial Diseases Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Budesonide Asthma Anti-Asthmatic Agents Hormones Glucocorticoids Leukotriene Antagonists |
Montelukast Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Bronchial Diseases Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Leukotriene Antagonists Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Therapeutic Uses Immune System Diseases |
Budesonide Asthma Anti-Asthmatic Agents Glucocorticoids Pharmacologic Actions Montelukast Autonomic Agents Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |