Last updated: 11/04/2018 11:12:42
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.
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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
Trial description: 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
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Mean percentage of symptom-free days over a 52-week treatment period
Timeframe: N/A
Secondary outcomes:
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)
Timeframe: N/A
Interventions:
Drug: Salmeterol/fluticasone propionate or formoterol/budesonide
Enrollment:
700
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical 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 RMA. Clinical Therapeutics 2005; 27(4): 393 406
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.
Fitzgerald, J., Boulet, L.P., Follows, R. 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. Clinical Therapeutics 2005; 27(4) 393-406
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.
Medical condition
Asthma
Product
budesonide, budesonide/formoterol, fluticasone propionate, fluticasone propionate/salmeterol, formoterol, salmeterol
Collaborators
Not applicable
Study date(s)
November 2002 to July 2004
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 70 years
Accepts healthy volunteers
No
- Documented clinical history of asthma
- Forced expiratory volume in 1 second between 60% and 90% of predicted
- Lower respiratory tract infection within 1 month of study entry
- Use of systemic corticosteroids within 1 month of study entry
Inclusion and exclusion criteria
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
Trial location(s)
Location
GSK Investigational Site
Bruchsal, Baden-Wuerttemberg, Germany, 76646
Status
Study Complete
Location
GSK Investigational Site
Blackpool, Lancashire, United Kingdom, FY4 3AD
Status
Recruiting
Location
GSK Investigational Site
's-HERTOGENBOSCH, Netherlands, 5211 NL
Status
Study Complete
Location
GSK Investigational Site
Cardiff, Glamorgan, United Kingdom, CF14 9BB
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Cardiff, Glamorgan, United Kingdom, CF23 5SY
Status
Study Complete
Location
GSK Investigational Site
Lahr, Baden-Wuerttemberg, Germany, 77933
Status
Study Complete
Location
GSK Investigational Site
Saffron Walden, Essex, United Kingdom, CB10 1EJ
Status
Study Complete
Location
GSK Investigational Site
Christchurch Hospital, New Zealand, 8001
Status
Study Complete
Location
GSK Investigational Site
Kippa Ring, Queensland, Australia, 4021
Status
Study Complete
Location
GSK Investigational Site
Toorak Gardens, South Australia, Australia, 5065
Status
Study Complete
Location
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M23 9GP
Status
Study Complete
Location
GSK Investigational Site
Saint John, New Brunswick, Canada, E2M 3W5
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Barry, Glamorgan, United Kingdom, CF63 4HP
Status
Study Complete
Location
GSK Investigational Site
Balmain, New South Wales, Australia, 2041
Status
Study Complete
Location
GSK Investigational Site
Blackpool, Lancashire, United Kingdom, FY1 6JW
Status
Study Complete
Location
GSK Investigational Site
Augsburg, Bayern, Germany, 86150
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Peterborough, Ontario, Canada, K9J 7B3
Status
Study Complete
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 3J5
Status
Study Complete
Location
GSK Investigational Site
Maple Ridge, British Columbia, Canada, V2X 2L5
Status
Study Complete
Location
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB3 9HS
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2004-28-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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