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| Sponsor: | AstraZeneca |
|---|---|
| Information provided by: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00385593 |
Purpose
This study is intended to extend the knowledge of Symbicort Single Inhaler Therapy into a more general setting in order to assess the real-life impact of introducing this new treatment concept. The study will compare the Symbicort Single Inhaler Therapy concept with a conventional stepwise treatment regimen according to the investigator's judgement in patients who present with symptoms on inhaled GCS treatment or who require and are already on treatment with a combination of inhaled GCS and LABA.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma, Bronchial |
Drug: Symbicort (budesonide/formoterol) Turbuhaler Drug: Conventional treatment |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Comparison 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 Adults - a 26-week, Randomised, Open-label, Parallel-group, Multicentre Study. Study SPAIN |
| Enrollment: | 791 |
| Study Start Date: | September 2006 |
| Study Completion Date: | October 2008 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 52 Study Locations| Study Director: | Carlos Barcina, MD | AstraZeneca |
More Information
| Study ID Numbers: | D5890L00010, 2005-005974-64, SPAIN |
| Study First Received: | October 6, 2006 |
| Results First Received: | October 14, 2009 |
| Last Updated: | October 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00385593 History of Changes |
| Health Authority: | Spain: Spanish Agency of Medicines |
|
Respiratory System Agents Bronchial Diseases Immune System Diseases Symbicort Asthma Anti-Asthmatic Agents Pharmacologic Actions |
Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Lung Diseases Therapeutic Uses Hypersensitivity, Immediate Respiratory Hypersensitivity |