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.

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GSK study ID
SAM40056
See study documents
Clinicaltrials.gov ID
NCT00479739
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    Not applicable
    Observational study model:
    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
    Status
    Contact us
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    Location
    GSK Investigational Site
    Galway, Ireland
    Status
    Will Be Recruiting
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 13353
    Status
    Study Complete
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    Location
    GSK Investigational Site
    EINDHOVEN, Netherlands, 5623 EJ
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Vienna, Austria, A-1120
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Varkaus, Finland, 78300
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Bruchsal, Baden-Wuerttemberg, Germany, 76646
    Status
    Study Complete
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    Showing 1 - 6 of 105 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    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.

    Additional information about the trial

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