CONCEPT: A 1-Year Comparison Of A Stable Dose Of SERETIDE® Inhaler With An Adjustable Maintenance Dose Of SYMBICORT® Inhaler. SERETIDE® Inhaler is a Trademark of GSK Group of Companies. SYMBICORT® Inhaler is a Trademark of Astra Zeneca.
NCT ID: NCT00479739
Last Updated: 2016-09-15
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
PHASE4
700 participants
INTERVENTIONAL
2002-11-30
2004-07-31
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
Study Groups
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Arm 1
Salmeterol/fluticasone propionate or formoterol/budesonide
Interventions
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Salmeterol/fluticasone propionate or formoterol/budesonide
Eligibility Criteria
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Inclusion Criteria
* Forced expiratory volume in 1 second between 60% and 90% of predicted
* Using an inhaled corticosteroid (ICS)at a dose equivalent to 200 to 500 mcg daily of beclomethasone (BDP)or equivalent combined with a long-acting beta-2-agonist or an ICS alone at a dose equivalent to \>500 to 1000mcg daily of BDP daily
Exclusion Criteria
* Use of systemic corticosteroids within 1 month of study entry
* Smoking history of 10 pack years or more Changes in regular asthma therapy within 12 weeks of study entry
* Any significant disorder that in the investigator's opinion might put the patient at risk or influence the study outcomes
18 Years
70 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Balmain, New South Wales, Australia
GSK Investigational Site
Brisbane, Queensland, Australia
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Kippa-Ring, Queensland, Australia
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Toorak Gardens, South Australia, Australia
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Linz, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Aalst, , Belgium
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Ath, , Belgium
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Gilly, , Belgium
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Hornu, , Belgium
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Leopoldsburg, , Belgium
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Oostham, , Belgium
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Tessenderlo, , Belgium
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Tienen, , Belgium
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Plovdiv, , Bulgaria
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Rousse, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Calgary, Alberta, Canada
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Maple Ridge, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Saint John, New Brunswick, Canada
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Brampton, Ontario, Canada
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Hamilton, Ontario, Canada
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Mississauga, Ontario, Canada
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Mississauga, Ontario, Canada
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Peterborough, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Sainte-Foy, Quebec, Canada
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Kohtal-Jdrve, , Estonia
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Tallinn, , Estonia
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Tallinn, , Estonia
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Tartu, , Estonia
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Jakobstad, , Finland
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Joensuu, , Finland
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Lahti, , Finland
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Raahe, , Finland
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Tampere, , Finland
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Varkaus, , Finland
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Bruchsal, Baden-Wurttemberg, Germany
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Lahr, Baden-Wurttemberg, Germany
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Augsburg, Bavaria, Germany
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Erlangen, Bavaria, Germany
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Munich, Bavaria, Germany
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Potsdam, Brandenburg, Germany
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Berlin, State of Berlin, Germany
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Berlin, State of Berlin, Germany
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Berlin, State of Berlin, Germany
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Berlin, State of Berlin, Germany
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Berlin, State of Berlin, Germany
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Berlin, State of Berlin, Germany
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Blackpool, Cork, , Ireland
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Dublin, , Ireland
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Dublin, , Ireland
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Dublin, , Ireland
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Dublin, , Ireland
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Galway, , Ireland
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Kilkenny, , Ireland
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Lifford, , Ireland
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Tallaght, Dublin, , Ireland
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Limbaži, , Latvia
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Riga, , Latvia
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Riga, , Latvia
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Valmiera, , Latvia
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's-Hertogenbosch, , Netherlands
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Almelo, , Netherlands
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Bennebroek, , Netherlands
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Eindhoven, , Netherlands
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Geldermalsen, , Netherlands
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Heerlen, , Netherlands
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Helmond, , Netherlands
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Losser, , Netherlands
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Made, , Netherlands
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Rotterdam, , Netherlands
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Spijkenisse, , Netherlands
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Utrecht, , Netherlands
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Voerendaal, , Netherlands
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Auckland, , New Zealand
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Auckland, , New Zealand
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Christchurch Hospital, , New Zealand
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Skopje, , North Macedonia
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A Coruña, , Spain
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Alcorcón, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Galdakano, , Spain
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Las Palmas, , Spain
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Lugo, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Valencia, , Spain
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Cambridge, Cambridgeshire, United Kingdom
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Saffron Walden, Essex, United Kingdom
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Barry, Glamorgan, United Kingdom
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Cardiff, Glamorgan, United Kingdom
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Cardiff, Glamorgan, United Kingdom
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Blackpool, Lancashire, United Kingdom
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Blackpool, Lancashire, United Kingdom
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Manchester, Lancashire, United Kingdom
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Fleetwood, , United Kingdom
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Fleetwood, , United Kingdom
Countries
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References
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Boulet LP, Fitzgerald M, Pieters R. The CONCEPT study: comparative influence of two treatment strategies on airway response to AMP. European Respiratory Journal Supplement 2005; 26: 429.
FitzGerald JM, Boulet LP, Follows RM. The CONCEPT trial: a 1-year, multicenter, randomized,double-blind, double-dummy comparison of a stable dosing regimen of salmeterol/fluticasone propionate with an adjustable maintenance dosing regimen of formoterol/budesonide in adults with persistent asthma. Clin Ther. 2005 Apr;27(4):393-406. doi: 10.1016/j.clinthera.2005.03.006.
Fitzgerald M, Boulet LP, Pieters WR. Improved control of symptoms and exacerbations with stable dose treatment with salmeterol/fluticasone propionate compared with adjustable maintenance dosing with formoterol/budesonide. European Respiratory Journal Supplement 2005; 26: 429.
Price D, Williams AE, Yoxall S. Quality of life of stable dose treatment with salmeterol/fluticasone compared with adjustable maintenance dosing with formoterol/budesonide. European Respiratory Journal Supplement 2005; 26(Suppl. 49): 252 (plus poster) abstr. P1720.
Price DB, Williams AE, Yoxall S. Salmeterol/fluticasone stable-dose treatment compared with formoterol/budesonide adjustable maintenance dosing: impact on health-related quality of life. Respir Res. 2007 Jul 4;8(1):46. doi: 10.1186/1465-9921-8-46.
Study Documents
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Document Type: Informed Consent Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Study Protocol
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Annotated Case Report Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Individual Participant Data Set
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Clinical Study Report
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Statistical Analysis Plan
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentRelated Links
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Other Identifiers
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SAM40056
Identifier Type: -
Identifier Source: org_study_id
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