Evaluation of Efficacy and Safety of Symbicort® as an add-on Treatment to Spiriva® in Patients With Severe COPD.
NCT ID: NCT00496470
Last Updated: 2012-11-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
660 participants
INTERVENTIONAL
2007-05-31
2008-06-30
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
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Symbicort+TIO
Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Symbicort (budesonide/formoterol turbuhaler 320/9ug)
Symbicort (budesonide/formoterol turbuhaler 320/9ug)
Spiriva® + Placebo Turbuhaler
Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Spiriva (tiotropium bromide 18ug)
Spiriva (tiotropium bromide 18ug)
Interventions
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Symbicort (budesonide/formoterol turbuhaler 320/9ug)
Symbicort (budesonide/formoterol turbuhaler 320/9ug)
Spiriva (tiotropium bromide 18ug)
Spiriva (tiotropium bromide 18ug)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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 R&D Lund
Tobias Welte, MD
Role: PRINCIPAL_INVESTIGATOR
Hannover Medical School
Locations
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Research Site
Concord, New South Wales, Australia
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Sydney, New South Wales, Australia
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Auchenflower, Queensland, Australia
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Carina Heights, Queensland, Australia
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North Mackay, Queensland, Australia
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Adelaide, South Australia, Australia
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Daw Park, South Australia, Australia
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Clayton, Victoria, Australia
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Malvern, Victoria, Australia
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Nedlands, Western Australia, Australia
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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St. John's, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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Mississauga, Ontario, Canada
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Toronto, Ontario, Canada
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La Malbaie, Quebec, Canada
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Trois-rivires, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Québec, , Canada
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Chamalières, , France
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Creil, , France
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Férolles-Attilly, , France
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Grasse, , France
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Lille, , France
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Marseille, , France
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Metz, , France
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Montpellier, , France
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Perpignan, , France
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Poitiers, , France
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Saint-Laurent-du-Var, , France
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Sélestat, , France
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Strasbourg, , France
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Toulouse, , France
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Berlin, , Germany
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Gelsenkirchen, , Germany
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Hagen, , Germany
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Hanover, , Germany
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Kassel, , Germany
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Koblenz, , Germany
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Leipzig, , Germany
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Marburg, , Germany
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Potsdam, , Germany
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Aszód, , Hungary
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Baja, , Hungary
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Balassagyarmat, , Hungary
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Budapest, , Hungary
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Cegléd, , Hungary
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Debrecen, , Hungary
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Füzesabony, , Hungary
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Jászberény, , Hungary
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Komló, , Hungary
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Nyíregyháza, , Hungary
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Törökbálint, , Hungary
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Vásárosnamény, , Hungary
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Bydgoszcz, , Poland
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Chrzanów, , Poland
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Iława, , Poland
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Krakow, , Poland
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Piekary Śląskie, , Poland
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Tarnów, , Poland
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Turek, , Poland
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Zawadzkie, , Poland
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Łomża, , Poland
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Košice, , Slovakia
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Liptovský Hrádok, , Slovakia
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Lučenec, , Slovakia
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Nové Mesto nad Váhom, , Slovakia
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Nové Zámky, , Slovakia
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Piešťany, , Slovakia
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Poprad, , Slovakia
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Považská Bystrica, , Slovakia
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Prešov, , Slovakia
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Prievidza, , Slovakia
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Revúca, , Slovakia
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Trnava, , Slovakia
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Žilina, , Slovakia
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Barcelona, Catalonia, Spain
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Reus (tarragona), Catalonia, Spain
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Pontevedra, Galicia, Spain
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Madrid, Madrid, Spain
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Requena (valencia), Valencia, Spain
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Valencia, Valencia, Spain
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Åtvidaberg, , Sweden
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Höllviken, , Sweden
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Limhamn, , Sweden
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Lund, , Sweden
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Malmo, , Sweden
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Motala, , Sweden
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Stockholm, , Sweden
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Uppsala, , Sweden
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Lindesberg, Örebro County, Sweden
Countries
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References
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Nielsen R, Kankaanranta H, Bjermer L, Lange P, Arnetorp S, Hedegaard M, Stenling A, Mittmann N. Cost effectiveness of adding budesonide/formoterol to tiotropium in COPD in four Nordic countries. Respir Med. 2013 Nov;107(11):1709-21. doi: 10.1016/j.rmed.2013.06.007. Epub 2013 Jul 13.
Mittmann N, Hernandez P, Mellstrom C, Brannman L, Welte T. Cost effectiveness of budesonide/formoterol added to tiotropium bromide versus placebo added to tiotropium bromide in patients with chronic obstructive pulmonary disease: Australian, Canadian and Swedish healthcare perspectives. Pharmacoeconomics. 2011 May;29(5):403-14. doi: 10.2165/11590380-000000000-00000.
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.
Welte T, Miravitlles M, Hernandez P, Eriksson G, Peterson S, Polanowski T, Kessler R. Efficacy and tolerability of budesonide/formoterol added to tiotropium in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2009 Oct 15;180(8):741-50. doi: 10.1164/rccm.200904-0492OC. Epub 2009 Jul 30.
Other Identifiers
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Eudract no:2006-006796-21
Identifier Type: -
Identifier Source: secondary_id
D5892C00015
Identifier Type: -
Identifier Source: org_study_id