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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00504062 |
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 |
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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 |
Ages Eligible for Study: | 5 Years to 15 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | D5254C00769 |
Study First Received: | July 17, 2007 |
Last Updated: | December 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00504062 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
asthma bronchial |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Budesonide |
Hypersensitivity, Immediate Fluticasone Asthma Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Bronchial Diseases Immune System Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Anti-Allergic Agents |
Glucocorticoids Hormones Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Dermatologic Agents Bronchodilator Agents |