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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 |
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study or the patient's ability to participate in the study.
Study Director: | Tomas Andersson | AstraZeneca |
Principal Investigator: | Akos Somoskovi | AstraZeneca |
Study ID Numbers: | D5897C00003 |
Study First Received: | September 27, 2007 |
Last Updated: | April 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00536731 |
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 |
Hypersensitivity Lung Diseases, Obstructive Symbicort Respiratory Tract Diseases Lung Diseases |
Budesonide Hypersensitivity, Immediate 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 |
Glucocorticoids Hormones Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |