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Sponsored by: |
AstraZeneca |
Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00259779 |
To assess if Symbicort forte Turbuhaler (during two weeks) is as effective as an oral course of prednisolone + Oxis Turbuhaler (during two weeks) for the treatment of an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD).
Condition | Intervention | Phase |
Chronic Obstructive Pulmonary Disease |
Drug: budesonide/formoterol Drug: Prednisolone |
Phase III |
MedlinePlus related topics: | COPD (Chronic Obstructive Pulmonary Disease) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomised, Double Blind, Double Dummy, Multicentre Phase III Study Comparing the Efficacy of Budesonide/Formoterol (Symbicort® Forte Turbuhaler®) and Oral Prednisolone + Formoterol (Oxis® Turbuhaler) During Two Weeks, in COPD Patients With an Acute Exacerbation, Followed by Twelve Weeks Open Follow up Period With Budesonide/Formoterol (Symbicort Forte Turbuhaler) |
Estimated Enrollment: | 120 |
Study Start Date: | September 2005 |
Study Completion Date: | September 2007 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 40 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
Denmark | |||||
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Aalborg, Denmark | |||||
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Aalbaek, Denmark | |||||
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Christiansfeld, Denmark | |||||
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Norager, Denmark | |||||
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Oksbol, Denmark | |||||
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Saeby, Denmark | |||||
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Erfurt, Denmark | |||||
Finland | |||||
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LOHJA, Finland | |||||
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PIETARSAARI, Finland | |||||
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PORVOO, Finland | |||||
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TAMMISAARI, Finland | |||||
Germany | |||||
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Berlin, Germany | |||||
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Leipzig, Germany | |||||
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Marburg, Germany | |||||
Norway | |||||
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STRAUME, Norway | |||||
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MOLDE, Norway | |||||
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OSLO, Norway | |||||
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FREDRIKSTAD, Norway | |||||
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HARSTAD, Norway | |||||
Sweden | |||||
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Trosa, Sweden | |||||
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Alingsas, Sweden | |||||
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Örebro, Sweden | |||||
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Motala, Sweden | |||||
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Limhamn, Sweden | |||||
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Goteborg, Sweden | |||||
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Atvidaberg, Sweden | |||||
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Akersberga, Sweden | |||||
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Sigtuna, Sweden | |||||
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Hollviken, Sweden | |||||
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Tumba, Sweden | |||||
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Kilafors, Sweden | |||||
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Stockholm, Sweden | |||||
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Borlange, Sweden | |||||
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Malmo, Sweden | |||||
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Uppsala, Sweden | |||||
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Lindesberg, Sweden | |||||
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Lulea, Sweden |
AstraZeneca |
Study Director: | AstraZeneca Symbicort Medical Science Director, MD | AstraZeneca |
AstraZeneca Clinical Trial Information - Outside US 
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Study ID Numbers: | D5892L00002, Eudra CT 2005-001090-10, SPACE |
First Received: | November 29, 2005 |
Last Updated: | February 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00259779 |
Health Authority: | Sweden: Medical Products Agency |
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