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.
September 13, 2016 updated by: GlaxoSmithKline
Randomised, Double-blind, Double-dummy, 52-week, Parallel Group Study of a Standard Dosing Regimen With Salmeterol/Fluticasone propionate50/250 Twice Daily Diskus Versus a Symptom-driven, Variable Dosing Regimen With Formoterol/Budesonide Combination 4.5/160 in Adult Asthmatics
To compare a stable dose of salmeterol/fluticasone propionate with a variable dose of formoterol/budesonide where the dose is adjusted according to a physician-guided self-management plan
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A randomised, double-blind, double-dummy, 52-week, parallel group study of a standard dosing regimen with salmeterol/fluticasone propionate combination 50/250mcg bid (via the DISKUS/ACCUHALER inhaler) versus a symptom-driven variable dosing regimen with formoterol/budesonide combination 6/200mcg (via a breath-actuated dry powder reservoir inhaler)in adults asthmatics
Study Type
Interventional
Enrollment (Actual)
700
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New South Wales
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Balmain, New South Wales, Australia, 2041
- GSK Investigational Site
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Queensland
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Brisbane, Queensland, Australia, 4077
- GSK Investigational Site
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Kippa Ring, Queensland, Australia, 4021
- GSK Investigational Site
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South Australia
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Toorak Gardens, South Australia, Australia, 5065
- GSK Investigational Site
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Linz, Austria, A-4020
- GSK Investigational Site
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Vienna, Austria, A-1030
- GSK Investigational Site
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Vienna, Austria, A-1120
- GSK Investigational Site
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Vienna, Austria, A-1210
- GSK Investigational Site
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Aalst, Belgium, 9300
- GSK Investigational Site
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Ath, Belgium, 7800
- GSK Investigational Site
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Gilly, Belgium, 6060
- GSK Investigational Site
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Hornu, Belgium, 7301
- GSK Investigational Site
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Leopoldsburg, Belgium, 3970
- GSK Investigational Site
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Oostham, Belgium, 3945
- GSK Investigational Site
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Tessenderlo, Belgium, 3980
- GSK Investigational Site
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Tienen, Belgium, 3300
- GSK Investigational Site
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Plovdiv, Bulgaria
- GSK Investigational Site
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Rousse, Bulgaria, 7000
- GSK Investigational Site
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Sofia, Bulgaria, 1606
- GSK Investigational Site
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Varna, Bulgaria, 9010
- GSK Investigational Site
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Alberta
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Calgary, Alberta, Canada, T2N 4N1
- GSK Investigational Site
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British Columbia
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Maple Ridge, British Columbia, Canada, V2X 2L5
- GSK Investigational Site
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Vancouver, British Columbia, Canada, V5Z 3J5
- GSK Investigational Site
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Manitoba
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Winnipeg, Manitoba, Canada, R2H 2A6
- GSK Investigational Site
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New Brunswick
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Saint John, New Brunswick, Canada, E2M 3W5
- GSK Investigational Site
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Ontario
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Brampton, Ontario, Canada, L6Y 2E6
- GSK Investigational Site
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Hamilton, Ontario, Canada, L8N 3Z5
- GSK Investigational Site
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Mississauga, Ontario, Canada, L5A 1N1
- GSK Investigational Site
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Mississauga, Ontario, Canada, L5M 2V8
- GSK Investigational Site
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Peterborough, Ontario, Canada, K9J 7B3
- GSK Investigational Site
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Quebec
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Montreal, Quebec, Canada, H4J 1C5
- GSK Investigational Site
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Montreal, Quebec, Canada, H3G 1A4
- GSK Investigational Site
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Sainte-Foy, Quebec, Canada, G1V 4G5
- GSK Investigational Site
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Kohtal-Jdrve, Estonia, 31 025
- GSK Investigational Site
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Tallinn, Estonia, 13419
- GSK Investigational Site
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Tallinn, Estonia, 10120
- GSK Investigational Site
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Tartu, Estonia, 51014
- GSK Investigational Site
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Joensuu, Finland, 80100
- GSK Investigational Site
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Lahti, Finland, 15850
- GSK Investigational Site
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Pietarsaari, Finland, 68600
- GSK Investigational Site
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Raahe, Finland, 92100
- GSK Investigational Site
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Tampere, Finland, 33520
- GSK Investigational Site
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Varkaus, Finland, 78300
- GSK Investigational Site
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Berlin, Germany, 13086
- GSK Investigational Site
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Berlin, Germany, 13353
- GSK Investigational Site
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Berlin, Germany, 10178
- GSK Investigational Site
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Berlin, Germany, 10717
- GSK Investigational Site
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Berlin, Germany, 13187
- GSK Investigational Site
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Berlin, Germany, 13597
- GSK Investigational Site
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Baden-Wuerttemberg
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Bruchsal, Baden-Wuerttemberg, Germany, 76646
- GSK Investigational Site
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Lahr, Baden-Wuerttemberg, Germany, 77933
- GSK Investigational Site
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Bayern
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Augsburg, Bayern, Germany, 86150
- GSK Investigational Site
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Erlangen, Bayern, Germany, 91052
- GSK Investigational Site
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Muenchen, Bayern, Germany, 81677
- GSK Investigational Site
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Brandenburg
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Potsdam, Brandenburg, Germany, 14469
- GSK Investigational Site
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Blackpool, Cork, Ireland
- GSK Investigational Site
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Dublin, Ireland, 22
- GSK Investigational Site
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Dublin, Ireland, 6
- GSK Investigational Site
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Dublin, Ireland, 8
- GSK Investigational Site
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Dublin, Ireland
- GSK Investigational Site
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Galway, Ireland
- GSK Investigational Site
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Kilkenny, Ireland
- GSK Investigational Site
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Lifford, Ireland
- GSK Investigational Site
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Tallaght, Dublin, Ireland, 24
- GSK Investigational Site
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Limbazi, Latvia, LV 4000
- GSK Investigational Site
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Riga, Latvia, LV 1002
- GSK Investigational Site
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Riga, Latvia, LV 1035
- GSK Investigational Site
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Valmiera, Latvia, LV 4201
- GSK Investigational Site
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Skopje, Macedonia, The Former Yugoslav Republic of, 9100
- GSK Investigational Site
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's-HERTOGENBOSCH, Netherlands, 5211 NL
- GSK Investigational Site
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Almelo, Netherlands, 7609 PP
- GSK Investigational Site
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Bennebroek, Netherlands, 2121 BB
- GSK Investigational Site
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Eindhoven, Netherlands, 5623 EJ
- GSK Investigational Site
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Geldermalsen, Netherlands, 4191 AH
- GSK Investigational Site
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Heerlen, Netherlands, 6419 PC
- GSK Investigational Site
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Helmond, Netherlands, 5707 HA
- GSK Investigational Site
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Losser, Netherlands, 7581 BV
- GSK Investigational Site
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Made, Netherlands, 4921 BC
- GSK Investigational Site
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Rotterdam, Netherlands, 3015 GD
- GSK Investigational Site
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Spijkenisse, Netherlands, 3207 NB
- GSK Investigational Site
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Utrecht, Netherlands, 2584 CX
- GSK Investigational Site
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Voerendaal, Netherlands, 6367 ED
- GSK Investigational Site
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Auckland, New Zealand, 1001
- GSK Investigational Site
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Auckland, New Zealand, 1701
- GSK Investigational Site
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Christchurch Hospital, New Zealand, 8001
- GSK Investigational Site
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Alcorcon, Spain, 28922
- GSK Investigational Site
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Barcelona, Spain, 08003
- GSK Investigational Site
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Barcelona, Spain, 08221
- GSK Investigational Site
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Galdakano, Spain, 48960
- GSK Investigational Site
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La Coruña, Spain, 15006
- GSK Investigational Site
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Las Palmas, Spain, 35020
- GSK Investigational Site
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Lugo, Spain, 27004
- GSK Investigational Site
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Madrid, Spain, 28041
- GSK Investigational Site
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Madrid, Spain, 28006
- GSK Investigational Site
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Malaga, Spain, 29400
- GSK Investigational Site
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Valencia, Spain, 46017
- GSK Investigational Site
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Fleetwood, United Kingdom, FY7 6HD
- GSK Investigational Site
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Fleetwood, United Kingdom, FY7 7DG
- GSK Investigational Site
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Cambridgeshire
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Cambridge, Cambridgeshire, United Kingdom, CB3 9HS
- GSK Investigational Site
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Essex
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Saffron Walden, Essex, United Kingdom, CB10 1EJ
- GSK Investigational Site
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Glamorgan
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Barry, Glamorgan, United Kingdom, CF63 4HP
- GSK Investigational Site
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Cardiff, Glamorgan, United Kingdom, CF14 9BB
- GSK Investigational Site
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Cardiff, Glamorgan, United Kingdom, CF23 5SY
- GSK Investigational Site
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Lancashire
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Blackpool, Lancashire, United Kingdom, FY1 6JW
- GSK Investigational Site
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Blackpool, Lancashire, United Kingdom, FY4 3AD
- GSK Investigational Site
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Manchester, Lancashire, United Kingdom, M23 9GP
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Documented clinical history of asthma
- 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:
- Lower respiratory tract infection within 1 month of study entry
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Arm 1
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Mean percentage of symptom-free days over a 52-week treatment period
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Secondary Outcome Measures
Outcome Measure |
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Mean percentage of rescue-free days Daily asthma symptom scores Daily rescue usage Mean morning peak flow Percentage of nights awoken due to asthma Rate of exacerbations Airway hyper-responsiveness(PC20 AMP)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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 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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2002
Primary Completion (Actual)
July 1, 2004
Study Completion (Actual)
July 1, 2004
Study Registration Dates
First Submitted
May 25, 2007
First Submitted That Met QC Criteria
May 25, 2007
First Posted (Estimate)
May 28, 2007
Study Record Updates
Last Update Posted (Estimate)
September 15, 2016
Last Update Submitted That Met QC Criteria
September 13, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Adrenergic Agonists
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Budesonide
- Fluticasone
- Xhance
- Salmeterol Xinafoate
- Formoterol Fumarate
Other Study ID Numbers
- SAM40056
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study Data/Documents
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Informed Consent Form
Information identifier: SAM40056Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Study Protocol
Information identifier: SAM40056Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Annotated Case Report Form
Information identifier: SAM40056Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Individual Participant Data Set
Information identifier: SAM40056Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Clinical Study Report
Information identifier: SAM40056Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Dataset Specification
Information identifier: SAM40056Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Statistical Analysis Plan
Information identifier: SAM40056Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.