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.

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00479739
• Other study ID #: SAM40056
• Status: Completed
• Phase: Phase 4
• First received: May 25, 2007
• Last updated: September 13, 2016
• Start date: November 2002
• Est. completion date: July 2004

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaSpain: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: July 2004
• Est. primary completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Salmeterol/fluticasone propionate or formoterol/budesonide

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Balmain	New South Wales
Australia	GSK Investigational Site	Brisbane	Queensland
Australia	GSK Investigational Site	Kippa Ring	Queensland
Australia	GSK Investigational Site	Toorak Gardens	South Australia
Austria	GSK Investigational Site	Linz
Austria	GSK Investigational Site	Vienna
Austria	GSK Investigational Site	Vienna
Austria	GSK Investigational Site	Vienna
Belgium	GSK Investigational Site	Aalst
Belgium	GSK Investigational Site	Ath
Belgium	GSK Investigational Site	Gilly
Belgium	GSK Investigational Site	Hornu
Belgium	GSK Investigational Site	Leopoldsburg
Belgium	GSK Investigational Site	Oostham
Belgium	GSK Investigational Site	Tessenderlo
Belgium	GSK Investigational Site	Tienen
Bulgaria	GSK Investigational Site	Plovdiv
Bulgaria	GSK Investigational Site	Rousse
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Varna
Canada	GSK Investigational Site	Brampton	Ontario
Canada	GSK Investigational Site	Calgary	Alberta
Canada	GSK Investigational Site	Hamilton	Ontario
Canada	GSK Investigational Site	Maple Ridge	British Columbia
Canada	GSK Investigational Site	Mississauga	Ontario
Canada	GSK Investigational Site	Mississauga	Ontario
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Peterborough	Ontario
Canada	GSK Investigational Site	Saint John	New Brunswick
Canada	GSK Investigational Site	Sainte-Foy	Quebec
Canada	GSK Investigational Site	Vancouver	British Columbia
Canada	GSK Investigational Site	Winnipeg	Manitoba
Estonia	GSK Investigational Site	Kohtal-Jdrve
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tartu
Finland	GSK Investigational Site	Joensuu
Finland	GSK Investigational Site	Lahti
Finland	GSK Investigational Site	Pietarsaari
Finland	GSK Investigational Site	Raahe
Finland	GSK Investigational Site	Tampere
Finland	GSK Investigational Site	Varkaus
Germany	GSK Investigational Site	Augsburg	Bayern
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bruchsal	Baden-Wuerttemberg
Germany	GSK Investigational Site	Erlangen	Bayern
Germany	GSK Investigational Site	Lahr	Baden-Wuerttemberg
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Potsdam	Brandenburg
Ireland	GSK Investigational Site	Blackpool, Cork
Ireland	GSK Investigational Site	Dublin
Ireland	GSK Investigational Site	Dublin
Ireland	GSK Investigational Site	Dublin
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
Latvia	GSK Investigational Site	Limbazi
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Valmiera
Macedonia, The Former Yugoslav Republic of	GSK Investigational Site	Skopje
Netherlands	GSK Investigational Site	's-HERTOGENBOSCH
Netherlands	GSK Investigational Site	Almelo
Netherlands	GSK Investigational Site	Bennebroek
Netherlands	GSK Investigational Site	Eindhoven
Netherlands	GSK Investigational Site	Geldermalsen
Netherlands	GSK Investigational Site	Heerlen
Netherlands	GSK Investigational Site	Helmond
Netherlands	GSK Investigational Site	Losser
Netherlands	GSK Investigational Site	Made
Netherlands	GSK Investigational Site	Rotterdam
Netherlands	GSK Investigational Site	Spijkenisse
Netherlands	GSK Investigational Site	Utrecht
Netherlands	GSK Investigational Site	Voerendaal
New Zealand	GSK Investigational Site	Auckland
New Zealand	GSK Investigational Site	Auckland
New Zealand	GSK Investigational Site	Christchurch Hospital
Spain	GSK Investigational Site	Alcorcon
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Galdakano
Spain	GSK Investigational Site	La Coruña
Spain	GSK Investigational Site	Las Palmas
Spain	GSK Investigational Site	Lugo
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Malaga
Spain	GSK Investigational Site	Valencia
United Kingdom	GSK Investigational Site	Barry	Glamorgan
United Kingdom	GSK Investigational Site	Blackpool	Lancashire
United Kingdom	GSK Investigational Site	Blackpool	Lancashire
United Kingdom	GSK Investigational Site	Cambridge	Cambridgeshire
United Kingdom	GSK Investigational Site	Cardiff	Glamorgan
United Kingdom	GSK Investigational Site	Cardiff	Glamorgan
United Kingdom	GSK Investigational Site	Fleetwood
United Kingdom	GSK Investigational Site	Fleetwood
United Kingdom	GSK Investigational Site	Manchester	Lancashire
United Kingdom	GSK Investigational Site	Saffron Walden	Essex

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Bulgaria,  Canada,  Estonia,  Finland,  Germany,  Ireland,  Latvia,  Macedonia, The Former Yugoslav Republic of,  Netherlands,  New Zealand,  Spain,  United Kingdom, 

References & Publications (4)

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/bu — View Citation

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 Supp

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) abs

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean percentage of symptom-free days over a 52-week treatment period
Secondary	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)

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.