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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00536731 |
The purpose of the this study is to evaluate the efficacy and safety of 2 actuations Symbicort®pMDI® 40/2.25 μg twice daily compared with1 inhalation Symbicort Turbuhaler® 80/4.5 μg twice daily and 1 inhalation Pulmicort®Turbuhaler® 100 μg twice daily for 6 weeks.
Condition | Intervention | Phase |
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Bronchial Asthma |
Drug: Symbicort Turbuhaler Drug: Symbicort pMDI Drug: Pulmicort Turbuhaler |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A 6-Week, Phase III, Double-Blind, Randomized, Multi-Centre, Parallel-Group Study Evaluating the Efficacy and Safety of 2 Actuations Symbicort®pMDI® 40/2.25 μg Twice Daily Compared With 1 Inhalation Symbicort Turbuhaler® 80/4.5 μg Twice Daily and 1 Inhalation Pulmicort®Turbuhaler® 100 μg Twice Daily |
Estimated Enrollment: | 600 |
Study Start Date: | September 2007 |
Study Completion Date: | April 2008 |
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Tomas Andersson | AstraZeneca |
Principal Investigator: | Akos Somoskovi | AstraZeneca |
Study ID Numbers: | D5897C00003 |
Study First Received: | September 27, 2007 |
Last Updated: | March 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00536731 History of Changes |
Health Authority: | Hungary: National Institute of Pharmacy (OGYI); Poland: Office for Registration of Medicinal Products; Czech Republic: State Institute for Drug Control; Bulgaria: Bulgarian Drug Agency (BDA) |
Asthma Symbicort |
Anti-Inflammatory Agents Bronchial Diseases Symbicort Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Budesonide Asthma Anti-Asthmatic Agents Hormones |
Glucocorticoids 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 Immune System Diseases Symbicort Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Budesonide Anti-Asthmatic Agents Asthma Hormones Glucocorticoids |
Pharmacologic Actions Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Autonomic Agents Therapeutic Uses Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |