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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00242775 |
The purpose of this study is to compare the efficacy and safety of a variable dose of Symbicort with a high fixed maintenance dose of another asthma medication, Seretide, in the treatment of asthma.
Condition | Intervention | Phase |
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Asthma |
Drug: Budesonide/formoterol Turbuhaler Drug: Salmeterol/fluticasone Diskus |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy and Safety of Symbicort ®Turbuhaler® 160/4.5 µg/Inhalation, Two Inhalations Twice Daily Plus as-Needed Compared With Seretide™ Diskus™ 50/500 µg/Inhalation, One Inhalation Twice Daily Plus Terbutaline Turbuhaler 0.4 mg/Inhalation as-Needed - a 6-Month, Randomised, Double-Blind, Parallel-Group, Active Controlled, Multinational Phase IIIB Study in Adult and Adolescent Patients With Persistent Asthma (AHEAD). |
Estimated Enrollment: | 2100 |
Study Start Date: | May 2005 |
Study Completion Date: | May 2006 |
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Additional inclusion and exclusion criteria will be evaluated by the Investigator.
Study Director: | AstraZeneca Symbicort Medical Science Director, MD | AstraZeneca |
Study ID Numbers: | D5890C00002, EurodraCT No. 2004-004905-11, AHEAD |
Study First Received: | October 20, 2005 |
Last Updated: | March 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00242775 History of Changes |
Health Authority: | Canada: Health Canada |
Asthma |
Anti-Inflammatory Agents Neurotransmitter Agents Salmeterol Adrenergic beta-Agonists Adrenergic Agents Bronchial Diseases Symbicort Budesonide Anti-Asthmatic Agents Asthma Anti-Allergic Agents Adrenergic Agonists |
Terbutaline Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate Fluticasone Formoterol Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Symbicort Bronchial Diseases Physiological Effects of Drugs Reproductive Control Agents Adrenergic Agonists Terbutaline Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Tocolytic Agents |
Therapeutic Uses Fluticasone Dermatologic Agents Immune System Diseases Adrenergic beta-Agonists Sympathomimetics Asthma Anti-Asthmatic Agents Anti-Allergic Agents Pharmacologic Actions Autonomic Agents Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents |