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| Sponsor: | AstraZeneca |
|---|---|
| Information provided by (Responsible Party): | 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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00504062 History of Changes |
| Other Study ID Numbers: | D5254C00769 |
| Study First Received: | July 17, 2007 |
| Last Updated: | August 23, 2011 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
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asthma bronchial |
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Budesonide Fluticasone Bronchodilator Agents Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Inflammatory Agents Dermatologic Agents Anti-Allergic Agents |