Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
AstraZeneca |
---|---|
Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00651547 |
The purpose of this study is to compare Symbicort with budesonide alone and formoterol alone in the treatment of asthma in children aged 6 to 11 years
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 (40/4.5 Mcg) Versus Its Mono-Products (Budesonide and Formoterol) in Asthmatic Children Aged Six to Eleven Years - SEEDLING 40/4.5 |
Estimated Enrollment: | 405 |
Study Start Date: | July 2002 |
Study Completion Date: | October 2003 |
Arms | Assigned Interventions |
---|---|
1: Experimental | Drug: budesonide/formoterol |
2: Active Comparator | Drug: budesonide |
3: Active Comparator | Drug: formoterol |
Ages Eligible for Study: | 6 Years to 11 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | SD-039-0718, D5896C00718 |
Study First Received: | April 1, 2008 |
Last Updated: | March 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00651547 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Asthma Symbicort budesonide/formoterol |
budesonide formoterol children |
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 |