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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00641914 |
A study of the effect of the early treatment with Pulmicort of newly diagnosed asthma. Patients will receive either Pulmicort or a non-active treatment for three years. Neither patients or investigators will be aware of the treatment received. After three years of treatment all patients will receive Pulmicort for 2 further years.
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: budesonide Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study |
Official Title: | Inhaled Steroid Treatment As Regular Therapy in Early Asthma. A Study on the Effect of Early Intervention With Long-Term Inhaled Budesonide (Pulmicort Turbuhaler ® ) in Newly Diagnosed Asthma. |
Estimated Enrollment: | 6800 |
Study Start Date: | October 1996 |
Study Completion Date: | February 2003 |
Primary Completion Date: | February 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental | Drug: budesonide |
2: Placebo Comparator | Drug: Placebo |
Ages Eligible for Study: | 6 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | AstraZeneca ( Lars-Göran Carlsson ) |
Study ID Numbers: | SD-004-0111, D5254C00111 |
Study First Received: | March 18, 2008 |
Last Updated: | March 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00641914 History of Changes |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Austria: Agency for Health and Food Safety; Australia: National Health and Medical Research Council; Belgium: Federal Agency for Medicinal Products and Health Products; Canada: Health Canada; China: State Food and Drug Administration; Czech Republic: State Institute for Drug Control; Germany: Federal Institute for Drugs and Medical Devices; Denmark: Danish Medicines Agency; Spain: Spanish Agency of Medicines; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Greece: Ministry of Health and Welfare; Hungary: National Institute of Pharmacy; Indonesia: National Agency of Drug and Food Control; Israel: Ministry of Health; Italy: Ministry of Health; Korea: Food and Drug Administration; Mexico: Ministry of Health; Malaysia: Ministry of Health; Norway: Norwegian Medicines Agency; Philippines: Bureau of Food and Drugs; Poland: Ministry of Health; Portugal: National Pharmacy and Medicines Institute; Sweden: Medical Products Agency; Singapore: Health Sciences Authority; Thailand: Food and Drug Administration; Taiwan: Department of Health; United States: Food and Drug Administration; South Africa: Department of Health |
Asthma Pulmicort budesonide |
Anti-Inflammatory Agents Bronchial Diseases Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Budesonide Asthma Anti-Asthmatic Agents Hormones Glucocorticoids |
Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Bronchial Diseases Immune System Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Budesonide Anti-Asthmatic Agents Asthma Hormones Glucocorticoids |
Pharmacologic Actions Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Autonomic Agents Therapeutic Uses Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |