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| Sponsor: | AstraZeneca |
|---|---|
| Information provided by: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00504062 |
Purpose
To investigate the effect and safety of budesonide Turbuhaler® 100 μg/dose and 200 μg/dose twice daily for 6 weeks in Japanese children with bronchial asthma aged 5 years to 15 years old in need for inhaled glucocorticosteroid treatment. To compare the efficacy of budesonide Turbuhaler® 100 μg/dose and 200 μg/dose twice daily for 6 weeks to that of fluticasone Diskus® 50 μg/dose and 100 μg/dose twice daily for 6 week.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: budesonide Drug: fluticasone |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Open-Label, Parallel-Group, 6 Week Treatment, Multi-Center, Phase III Study to Investigate the Efficacy and Safety of 100ug and 200ug Twice Daily of Budesonide Turbuhaler® and 50ug and 100umg Twice Daily of Fluticasone Diskus® in Japanese Children With Bronchial Asthma Aged 5-15 |
| Enrollment: | 240 |
| Study Start Date: | October 2006 |
| Study Completion Date: | October 2007 |
Eligibility| Ages Eligible for Study: | 5 Years to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | D5254C00769 |
| Study First Received: | July 17, 2007 |
| Last Updated: | December 17, 2007 |
| ClinicalTrials.gov Identifier: | NCT00504062 History of Changes |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
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asthma bronchial |
|
Anti-Inflammatory Agents Respiratory System Agents Bronchial Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Therapeutic Uses Fluticasone Dermatologic Agents Immune System Diseases |
Budesonide Asthma Anti-Asthmatic Agents Anti-Allergic Agents Glucocorticoids Pharmacologic Actions Autonomic Agents Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |