Evaluation of Efficacy and Safety of Symbicort® as an add-on Treatment to Spiriva® in Patients With Severe COPD.
A 12-week, Double-blind, Randomised, Parallel Group, Multi-centre, Study to Evaluate Efficacy and Safety of Budesonide/Formoterol (Symbicort Turbuhaler®) 320/9 µg One Inhalation Twice Daily on Top of Tiotropium (Spiriva®) 18 µg One Inhalation Once Daily
2 other identifiers
interventional
660
9 countries
93
Brief Summary
The purpose of this study is to investigate the effect of combined treatment with Symbicort and Spiriva, in terms of improvement of lung function, symptoms and inflammatory markers, in patients with severe COPD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2007
Shorter than P25 for phase_4
93 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 3, 2007
CompletedFirst Posted
Study publicly available on registry
July 4, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
November 9, 2012
CompletedNovember 9, 2012
October 1, 2012
1.1 years
July 3, 2007
June 15, 2009
October 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Forced Expiratory Volume in 1 Second (FEV1) Pre-dose
Change in the pre-dose FEV1from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)
Baseline to 12 weeks
Secondary Outcomes (36)
Forced Expiratory Volume in 1 Second (FEV1) 5 Min Post-dose
Baseline to 12 weeks
Forced Expiratory Volume in 1 Second (FEV1) 60 Min Post-dose
Baseline to 12 weeks
Forced Vital Capacity (FVC) Pre-dose
Baseline to 12 weeks
Forced Vital Capacity (FVC) 5 Minutes Post-dose
Baseline to 12 weeks
Forced Vital Capacity (FVC) 60 Minutes Post-dose
Baseline to 12 weeks
- +31 more secondary outcomes
Study Arms (2)
Symbicort+TIO
ACTIVE COMPARATORSymbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® + Placebo Turbuhaler
ACTIVE COMPARATORSpiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
Interventions
Symbicort (budesonide/formoterol turbuhaler 320/9ug)
Eligibility Criteria
You may qualify if:
- \>=40 years of age, diagnosed COPD with symptoms \>=2 years, pre-bronchodilatory FEV1 \<=50% of PN
You may not qualify if:
- Current respiratory tract disorder other than COPD, history of asthma or rhinitis, significant or unstable cardiovascular disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (93)
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
Related Publications (4)
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.
PMID: 23856511DERIVEDMittmann 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.
PMID: 21504240DERIVEDPartridge 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.
PMID: 19897551DERIVEDWelte 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.
PMID: 19644045DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Tomas Andersson, MD
AstraZeneca R&D Lund
- PRINCIPAL INVESTIGATOR
Tobias Welte, MD
Hannover Medical School
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2007
First Posted
July 4, 2007
Study Start
May 1, 2007
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
November 9, 2012
Results First Posted
November 9, 2012
Record last verified: 2012-10