Evaluation of Onset of Effect in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD) Treated With Symbicort® Compared to Seretide®
NCT ID: NCT00542880
Last Updated: 2012-08-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
442 participants
INTERVENTIONAL
2007-09-30
2008-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Symbicort Turbuhaler First, then Seretide Diskus
Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg
Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
Seretide Diskus (salmeterol/fluticasone) 50/500 μg
Seretide Diskus First, then Symbicort Turbuhaler
Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
Seretide Diskus (salmeterol/fluticasone) 50/500 μg
Interventions
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Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
Seretide Diskus (salmeterol/fluticasone) 50/500 μg
Eligibility Criteria
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Inclusion Criteria
* FEV1 ≤50% of predicted normal value, pre-bronchodilator, FEV1/VC \<70%
* Pre-bronchodilator
Exclusion Criteria
* History of asthma or rhinitis
* Significant or unstable cardiovascular disorder
40 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Tomas Andersson, MD
Role: STUDY_DIRECTOR
AstraZeneca
Martyn R Partridge, MD FRCP
Role: PRINCIPAL_INVESTIGATOR
Faculty of Medicine, Imperial College, NHLI at Charing Cross Hospital, LONDON, UK
Locations
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Research Site
Monte Grande, Buenos Aires, Argentina
Research Site
Quilmes, Buenos Aires, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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Ciudad Autonoma de Bs. As., , Argentina
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Ciudad de Buenos Aires, , Argentina
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Concord, New South Wales, Australia
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Adelaide, South Australia, Australia
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Daw Park, South Australia, Australia
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Woodville South, South Australia, Australia
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Melbourne, Victoria, Australia
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Parkville, Victoria, Australia
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Nedlands, Western Australia, Australia
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Jambes, Belgium, Belgium
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Malmedy, Belgium, Belgium
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Montigny-le-Tilleul, Belgium, Belgium
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Porto Alegre, Brasil, Brazil
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Juiz de Fora, Minas Gerais, Brazil
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Recife, Pernambuco, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Florianópolis, Santa Catarina, Brazil
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Santo André, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Rio de Janeiro, , Brazil
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Aalborg, , Denmark
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Hellerup, , Denmark
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Hvidovre, , Denmark
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København NV, , Denmark
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Odense C, , Denmark
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Rødovre Municipality, , Denmark
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Silkeborg, , Denmark
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Berlin, , Germany
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Erfurt, , Germany
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Leipzig, , Germany
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Marburg, , Germany
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Hyderabad, Andhra Pradesh, India
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Bangalore, Karnataka, India
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Jaipur, Rajasthan, India
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Coimbatore, , India
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Noida, , India
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Manila, , Philippines
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Quezon City, , Philippines
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Dartford, Kent, United Kingdom
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Hamilton, Lanarkshire, United Kingdom
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Motherwell, Lanarkshire, United Kingdom
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Cookstown, Northern Ireland, United Kingdom
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Limavady, Northern Ireland, United Kingdom
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Newtownabbey, Northern Ireland, United Kingdom
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Barry, South Glamorgan, United Kingdom
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Barry, Vale of Glamorgan, United Kingdom
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Bradford-on-Avon, Wiltshire, United Kingdom
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Airdrie, , United Kingdom
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Birmingham, , United Kingdom
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Blantyre, , United Kingdom
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Bolton, , United Kingdom
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Carrickfergus, , United Kingdom
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Chesterfield, , United Kingdom
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Coventry, , United Kingdom
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Hamilton, , United Kingdom
Countries
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References
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Partridge MR, Miravitlles M, Stahl E, Karlsson N, Svensson K, Welte T. Development and validation of the Capacity of Daily Living during the Morning questionnaire and the Global Chest Symptoms Questionnaire in COPD. Eur Respir J. 2010 Jul;36(1):96-104. doi: 10.1183/09031936.00123709. Epub 2009 Nov 6.
Other Identifiers
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D5892C00016
Identifier Type: -
Identifier Source: org_study_id