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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00536913 |
The purpose of the study is to compare Symbicort pMDI with and without spacer in terms of steroid potency, improvement of lung function and asthma symptoms in children with asthma (6-11 years).
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: Budesonide/formoterol pMDI 40/2.25ug + spacer Drug: Budesonide/formoterol pMDI 40/2.25 ug |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 4-Week, Open-Label, Randomized, Multi-Centre, Parallel-Group Study Evaluating the Safety and Efficacy of 4 Actuations Symbicort® (Budesonide/Formoterol) HFA pMDI 40/2.25 μg Twice Daily, With and Without Spacer, in Children (6-11 Years) With Asthma |
Estimated Enrollment: | 100 |
Study Start Date: | September 2007 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 6 Years to 11 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Hungary | |
Research Site | |
Budapest, Hungary | |
Research Site | |
Debrecen, Hungary | |
Research Site | |
Kaposvar, Hungary | |
Poland | |
Research Site | |
Biaystok, Poland | |
Research Site | |
Bydgoszcz, Poland | |
Research Site | |
Bytom, Poland | |
Research Site | |
Karpacz, Poland | |
Research Site | |
Krakow, Poland | |
Research Site | |
Od, Poland | |
Research Site | |
Warszawa, Poland | |
Russian Federation | |
Research Site | |
Moscow, Russian Federation |
Study Director: | Tomas Anderson, MD PhD | AstraZeneca |
Principal Investigator: | Piotr Kuna, MD PhD | Uniwersytecki Spital |
Study ID Numbers: | D5897C00004 |
Study First Received: | September 26, 2007 |
Last Updated: | March 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00536913 History of Changes |
Health Authority: | Hungary: National Institute of Pharmacy; Poland: Ministry of Health; Russia: Ministry of Health and Social Welfare |
Symbicort pMDI spacer 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 |