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.
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
1 other identifier
interventional
700
13 countries
91
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 asthma
Started Nov 2002
91 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
November 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 25, 2007
CompletedFirst Posted
Study publicly available on registry
May 28, 2007
CompletedSeptember 15, 2016
September 1, 2016
1.7 years
May 25, 2007
September 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean percentage of symptom-free days over a 52-week treatment period
Secondary Outcomes (1)
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)
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (106)
GSK Investigational Site
Balmain, New South Wales, 2041, Australia
GSK Investigational Site
Brisbane, Queensland, 4077, Australia
GSK Investigational Site
Kippa-Ring, Queensland, 4021, Australia
GSK Investigational Site
Toorak Gardens, South Australia, 5065, Australia
GSK Investigational Site
Linz, A-4020, Austria
GSK Investigational Site
Vienna, A-1030, Austria
GSK Investigational Site
Vienna, A-1120, Austria
GSK Investigational Site
Vienna, A-1210, Austria
GSK Investigational Site
Aalst, 9300, Belgium
GSK Investigational Site
Ath, 7800, Belgium
GSK Investigational Site
Gilly, 6060, Belgium
GSK Investigational Site
Hornu, 7301, Belgium
GSK Investigational Site
Leopoldsburg, 3970, Belgium
GSK Investigational Site
Oostham, 3945, Belgium
GSK Investigational Site
Tessenderlo, 3980, Belgium
GSK Investigational Site
Tienen, 3300, Belgium
GSK Investigational Site
Plovdiv, Bulgaria
GSK Investigational Site
Rousse, 7000, Bulgaria
GSK Investigational Site
Sofia, 1606, Bulgaria
GSK Investigational Site
Varna, 9010, Bulgaria
GSK Investigational Site
Calgary, Alberta, T2N 4N1, Canada
GSK Investigational Site
Maple Ridge, British Columbia, V2X 2L5, Canada
GSK Investigational Site
Vancouver, British Columbia, V5Z 3J5, Canada
GSK Investigational Site
Winnipeg, Manitoba, R2H 2A6, Canada
GSK Investigational Site
Saint John, New Brunswick, E2M 3W5, Canada
GSK Investigational Site
Brampton, Ontario, L6Y 2E6, Canada
GSK Investigational Site
Hamilton, Ontario, L8N 3Z5, Canada
GSK Investigational Site
Mississauga, Ontario, L5A 1N1, Canada
GSK Investigational Site
Mississauga, Ontario, L5M 2V8, Canada
GSK Investigational Site
Peterborough, Ontario, K9J 7B3, Canada
GSK Investigational Site
Montreal, Quebec, H3G 1A4, Canada
GSK Investigational Site
Montreal, Quebec, H4J 1C5, Canada
GSK Investigational Site
Sainte-Foy, Quebec, G1V 4G5, Canada
GSK Investigational Site
Kohtal-Jdrve, 31 025, Estonia
GSK Investigational Site
Tallinn, 10120, Estonia
GSK Investigational Site
Tallinn, 13419, Estonia
GSK Investigational Site
Tartu, 51014, Estonia
GSK Investigational Site
Jakobstad, 68600, Finland
GSK Investigational Site
Joensuu, 80100, Finland
GSK Investigational Site
Lahti, 15850, Finland
GSK Investigational Site
Raahe, 92100, Finland
GSK Investigational Site
Tampere, 33520, Finland
GSK Investigational Site
Varkaus, 78300, Finland
GSK Investigational Site
Bruchsal, Baden-Wurttemberg, 76646, Germany
GSK Investigational Site
Lahr, Baden-Wurttemberg, 77933, Germany
GSK Investigational Site
Augsburg, Bavaria, 86150, Germany
GSK Investigational Site
Erlangen, Bavaria, 91052, Germany
GSK Investigational Site
Munich, Bavaria, 81677, Germany
GSK Investigational Site
Potsdam, Brandenburg, 14469, Germany
GSK Investigational Site
Berlin, State of Berlin, 10178, Germany
GSK Investigational Site
Berlin, State of Berlin, 10717, Germany
GSK Investigational Site
Berlin, State of Berlin, 13086, Germany
GSK Investigational Site
Berlin, State of Berlin, 13187, Germany
GSK Investigational Site
Berlin, State of Berlin, 13353, Germany
GSK Investigational Site
Berlin, State of Berlin, 13597, Germany
GSK Investigational Site
Blackpool, Cork, Ireland
GSK Investigational Site
Dublin, 22, Ireland
GSK Investigational Site
Dublin, 6, Ireland
GSK Investigational Site
Dublin, 8, Ireland
GSK Investigational Site
Dublin, Ireland
GSK Investigational Site
Galway, Ireland
GSK Investigational Site
Kilkenny, Ireland
GSK Investigational Site
Lifford, Ireland
GSK Investigational Site
Tallaght, Dublin, 24, Ireland
GSK Investigational Site
Limbaži, LV 4000, Latvia
GSK Investigational Site
Riga, LV 1002, Latvia
GSK Investigational Site
Riga, LV 1035, Latvia
GSK Investigational Site
Valmiera, LV 4201, Latvia
GSK Investigational Site
's-Hertogenbosch, 5211 NL, Netherlands
GSK Investigational Site
Almelo, 7609 PP, Netherlands
GSK Investigational Site
Bennebroek, 2121 BB, Netherlands
GSK Investigational Site
Eindhoven, 5623 EJ, Netherlands
GSK Investigational Site
Geldermalsen, 4191 AH, Netherlands
GSK Investigational Site
Heerlen, 6419 PC, Netherlands
GSK Investigational Site
Helmond, 5707 HA, Netherlands
GSK Investigational Site
Losser, 7581 BV, Netherlands
GSK Investigational Site
Made, 4921 BC, Netherlands
GSK Investigational Site
Rotterdam, 3015 GD, Netherlands
GSK Investigational Site
Spijkenisse, 3207 NB, Netherlands
GSK Investigational Site
Utrecht, 2584 CX, Netherlands
GSK Investigational Site
Voerendaal, 6367 ED, Netherlands
GSK Investigational Site
Auckland, 1001, New Zealand
GSK Investigational Site
Auckland, 1701, New Zealand
GSK Investigational Site
Christchurch Hospital, 8001, New Zealand
GSK Investigational Site
Skopje, 9100, North Macedonia
GSK Investigational Site
A Coruña, 15006, Spain
GSK Investigational Site
Alcorcón, 28922, Spain
GSK Investigational Site
Barcelona, 08003, Spain
GSK Investigational Site
Barcelona, 08221, Spain
GSK Investigational Site
Galdakano, 48960, Spain
GSK Investigational Site
Las Palmas, 35020, Spain
GSK Investigational Site
Lugo, 27004, Spain
GSK Investigational Site
Madrid, 28006, Spain
GSK Investigational Site
Madrid, 28041, Spain
GSK Investigational Site
Málaga, 29400, Spain
GSK Investigational Site
Valencia, 46017, Spain
GSK Investigational Site
Cambridge, Cambridgeshire, CB3 9HS, United Kingdom
GSK Investigational Site
Saffron Walden, Essex, CB10 1EJ, United Kingdom
GSK Investigational Site
Barry, Glamorgan, CF63 4HP, United Kingdom
GSK Investigational Site
Cardiff, Glamorgan, CF14 9BB, United Kingdom
GSK Investigational Site
Cardiff, Glamorgan, CF23 5SY, United Kingdom
GSK Investigational Site
Blackpool, Lancashire, FY1 6JW, United Kingdom
GSK Investigational Site
Blackpool, Lancashire, FY4 3AD, United Kingdom
GSK Investigational Site
Manchester, Lancashire, M23 9GP, United Kingdom
GSK Investigational Site
Fleetwood, FY7 6HD, United Kingdom
GSK Investigational Site
Fleetwood, FY7 7DG, United Kingdom
Related Publications (5)
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.
RESULTFitzGerald 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.
PMID: 15922813RESULTFitzgerald 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.
RESULTPrice 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.
RESULTPrice 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.
PMID: 17610727DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2007
First Posted
May 28, 2007
Study Start
November 1, 2002
Primary Completion
July 1, 2004
Study Completion
July 1, 2004
Last Updated
September 15, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.