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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00652002 |
The purpose of this study is to compare Symbicort with budesonide alone and with formoterol alone in the treatment of asthma in adolescents and adults
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: budesonide/formoterol Drug: budesonide Drug: formoterol |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 12 Week, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Trial of Symbicort TM (160/4.5mcg) Versus Its Mono-Products (Budesonide and Formoterol) in Adolescents (at Least 12 Years of Age) and Adults With Asthma - SPRUCE 160/4.5 |
Estimated Enrollment: | 450 |
Study Start Date: | July 2002 |
Study Completion Date: | January 2004 |
Arms | Assigned Interventions |
---|---|
1: Experimental | Drug: budesonide/formoterol |
2: Active Comparator
budesonide
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Drug: budesonide |
3: Active Comparator
formoterol
|
Drug: formoterol |
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | SD-039-0717, D5896C00717 |
Study First Received: | April 1, 2008 |
Last Updated: | March 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00652002 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Asthma Symbicort budesonide/formoterol budesonide formoterol |
Anti-Inflammatory Agents Neurotransmitter Agents Adrenergic beta-Agonists Adrenergic Agents Bronchial Diseases Symbicort Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Budesonide Anti-Asthmatic Agents Asthma Hormones |
Glucocorticoids Adrenergic Agonists Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate 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 Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Adrenergic Agonists Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Therapeutic Uses |
Formoterol Immune System Diseases Adrenergic beta-Agonists Budesonide Asthma Anti-Asthmatic Agents Glucocorticoids Pharmacologic Actions Autonomic Agents Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |