Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
120 participants
INTERVENTIONAL
2005-09-30
2007-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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budesonide/formoterol
Prednisolone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* After the acute treatment a simple pulmonary function test shows a value of 30%-60% of the predicted normal value.
* Patients, who, based on the clinical examination after the initial acute treatment, are candidates for a course of oral steroids for the treatment of acute symptoms due to chronic obstructive pulmonary disease
Exclusion Criteria
* Oxygen uptake (saturation) is \<92% after the initial acute treatment
* A requirement for regular use of oxygen therapy
* Regular treatment with any inhaled steroid \>1 000 µg/day at study entry
40 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Principal Investigators
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AstraZeneca Symbicort Medical Science Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Aalborg, , Denmark
Research Site
Ålbæk, , Denmark
Research Site
Christiansfeld, , Denmark
Research Site
Erfurt, , Denmark
Research Site
Nørager, , Denmark
Research Site
Oksbøl, , Denmark
Research Site
Sæby, , Denmark
Research Site
Ekenäs, , Finland
Research Site
Jakobstad, , Finland
Research Site
Lohja, , Finland
Research Site
Porvoo, , Finland
Research Site
Berlin, , Germany
Research Site
Leipzig, , Germany
Research Site
Marburg, , Germany
Research Site
Fredrikstad, , Norway
Research Site
Harstad, , Norway
Research Site
Molde, , Norway
Research Site
Oslo, , Norway
Research Site
Straume, , Norway
Research Site
Alingsås, , Sweden
Research Site
Åkersberga, , Sweden
Research Site
Åtvidaberg, , Sweden
Research Site
Borlänge, , Sweden
Research Site
Gothenburg, , Sweden
Research Site
Höllviken, , Sweden
Research Site
Kilafors, , Sweden
Research Site
Limhamn, , Sweden
Research Site
Lindesberg, , Sweden
Research Site
Luleå, , Sweden
Research Site
Malmo, , Sweden
Research Site
Motala, , Sweden
Research Site
Örebro, , Sweden
Research Site
Sigtuna, , Sweden
Research Site
Stockholm, , Sweden
Research Site
Trosa, , Sweden
Research Site
Tumba, , Sweden
Research Site
Uppsala, , Sweden
Countries
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References
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Stallberg B, Selroos O, Vogelmeier C, Andersson E, Ekstrom T, Larsson K. Budesonide/formoterol as effective as prednisolone plus formoterol in acute exacerbations of COPD. A double-blind, randomised, non-inferiority, parallel-group, multicentre study. Respir Res. 2009 Feb 19;10(1):11. doi: 10.1186/1465-9921-10-11.
Other Identifiers
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Eudra CT 2005-001090-10
Identifier Type: -
Identifier Source: secondary_id
SPACE
Identifier Type: -
Identifier Source: secondary_id
D5892L00002
Identifier Type: -
Identifier Source: org_study_id
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