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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00252824 |
The purpose of the study is to compare the efficacy of a flexible dose of Symbicort with conventional stepwise treatment according to asthma treatment guidelines in patients with persistent asthma
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: Budesonide/formoterol Turbuhaler vs Conventional Best Asthma Therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Comparison of the Efficacy of Symbicort® Single Inhaler Therapy (Symbicort Turbuhaler® 160/4.5 mg 1 Inhalation b.i.d. Plus as-Needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents and Adults - a 26 Weeks, Randomised, Open-Label, Parallel-Group, Multicentre Study |
Estimated Enrollment: | 1000 |
Study Start Date: | July 2005 |
Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
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: | D5890L00014, STYLE |
Study First Received: | November 10, 2005 |
Last Updated: | January 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00252824 |
Health Authority: | Portugal: National Pharmacy and Medicines Institute |
Hypersensitivity Lung Diseases, Obstructive Symbicort Respiratory Tract Diseases Lung Diseases |
Budesonide Hypersensitivity, Immediate Formoterol Asthma Respiratory Hypersensitivity |
Respiratory System Agents Immune System Diseases Bronchial Diseases |
Therapeutic Uses Anti-Asthmatic Agents Pharmacologic Actions |