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CONCEPT: A 1-Year Comparison Of A Stable Dose Of SERETIDE With An Adjustable Maintenance Dose Of SYMBICORT

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Salmeterol/fluticasone propionate or formoterol/budesonide (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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

Clinical Details

Official title: Randomised, Double-blind, Double-dummy, 52-week, Parallel Group Study of a Standard Dosing Regimen With Salmeterol/Fluticasone propionate50/250bid Diskus Versus a Symptom-driven, Variable Dosing Regimen With Formoterol/Budesonide Combination 4.5/160 in Adult Asthmatics

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Mean percentage of symptom-free days over a 52-week treatment period

Secondary outcome: 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)

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

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

GSK Investigational Site, Linz A-4020, Austria

GSK Investigational Site, Vienna A-1210, Austria

GSK Investigational Site, Vienna A-1120, Austria

GSK Investigational Site, Vienna A-1030, Austria

GSK Investigational Site, Aalst 9300, Belgium

GSK Investigational Site, Ath 7800, Belgium

GSK Investigational Site, Boussu 7301, Belgium

GSK Investigational Site, Gilly 6060, 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, 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, Joensuu 80100, Finland

GSK Investigational Site, Lahti 15850, Finland

GSK Investigational Site, Pietarsaari 68600, Finland

GSK Investigational Site, Raahe 92100, Finland

GSK Investigational Site, Tampere 33520, Finland

GSK Investigational Site, Varkaus 78300, Finland

GSK Investigational Site, Berlin 13353, Germany

GSK Investigational Site, Berlin 10717, Germany

GSK Investigational Site, Berlin 13086, Germany

GSK Investigational Site, Berlin 13187, Germany

GSK Investigational Site, Berlin 10178, Germany

GSK Investigational Site, 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, Limbazi 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, Skopje 9100, Macedonia, The Former Yugoslav Republic of

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, Alcorcon 28922, Spain

GSK Investigational Site, Barcelona 08003, Spain

GSK Investigational Site, Barcelona 08221, Spain

GSK Investigational Site, Galdakano 48960, Spain

GSK Investigational Site, La Coruña 15006, 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, Malaga 29400, Spain

GSK Investigational Site, Valencia 46017, Spain

GSK Investigational Site, Fleetwood FY7 6HD, United Kingdom

GSK Investigational Site, Fleetwood FY7 7DG, United Kingdom

GSK Investigational Site, Calgary, Alberta T2N 4N1, Canada

GSK Investigational Site, Bruchsal, Baden-Wuerttemberg 76646, Germany

GSK Investigational Site, Lahr, Baden-Wuerttemberg 77933, Germany

GSK Investigational Site, Augsburg, Bayern 86150, Germany

GSK Investigational Site, Erlangen, Bayern 91052, Germany

GSK Investigational Site, Muenchen, Bayern 81677, Germany

GSK Investigational Site, Potsdam, Brandenburg 14469, Germany

GSK Investigational Site, Maple Ridge, British Columbia V2X 2L5, Canada

GSK Investigational Site, Vancouver, British Columbia V5Z 3J5, Canada

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, Winnipeg, Manitoba R2H 2A6, Canada

GSK Investigational Site, Saint John, New Brunswick E2M 3W5, Canada

GSK Investigational Site, Balmain, New South Wales 2041, Australia

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, Brisbane, Queensland 4077, Australia

GSK Investigational Site, Kippa Ring, Queensland 4021, Australia

GSK Investigational Site, Toorak Gardens, South Australia 5065, Australia

Additional Information

Starting date: November 2002
Last updated: September 5, 2013

Page last updated: August 23, 2015

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