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

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, MD, Study Director, Affiliation: GlaxoSmithKline

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

Official title: 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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

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)

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

GSK Clinical Trials Call Center, Toorak Gardens SA5065, Australia

GSK Clinical Trials Call Center, Linz 4020 Linz, Austria

GSK Clinical Trials Call Center, Vienna 1120 Wien, Austria

GSK Clinical Trials Call Center, Vienna 1210 Wien, Austria

GSK Clinical Trials Call Center, Vienna 1030 Wien, Austria

GSK Clinical Trials Call Center, Oostham 3945, Belgium

GSK Clinical Trials Call Center, Tessenderlo 3980, Belgium

GSK Clinical Trials Call Center, Tienen 3300, Belgium

GSK Clinical Trials Call Center, Leopoldsburg 3970, Belgium

GSK Clinical Trials Call Center, Boussu 7301, Belgium

GSK Clinical Trials Call Center, Aalst 9300, Belgium

GSK Clinical Trials Call Center, Kortrijk 8500, Belgium

GSK Clinical Trials Call Center, Varna 9000, Bulgaria

GSK Clinical Trials Call Center, Plovdiv 8000, Bulgaria

GSK Clinical Trials Call Center, Rousse 7000, Bulgaria

GSK Clinical Trials Call Center, Sofia 1606, Bulgaria

GSK Clinical Trials Call Center, Quebec G1V 4G5, Canada

GSK Clinical Trials Call Center, Tartu 51054, Estonia

GSK Clinical Trials Call Center, Kohtla-Jarve 16894, Estonia

GSK Clinical Trials Call Center, Tallinn 13513, Estonia

GSK Clinical Trials Call Center, Tallinn 13419, Estonia

GSK Clinical Trials Call Center, Joensuu 80101, Finland

GSK Clinical Trials Call Center, Varkaus 78300, Finland

GSK Clinical Trials Call Center, Raahe 92100, Finland

GSK Clinical Trials Call Center, Lahti 15850, Finland

GSK Clinical Trials Call Center, Pietarsaari 68601, Finland

GSK Clinical Trials Call Center, Tampere 33820, Finland

GSK Clinical Trials Call Center, Kippenheim 77971, Germany

GSK Clinical Trials Call Center, Berlin 13187, Germany

GSK Clinical Trials Call Center, Berlin 10717, Germany

GSK Clinical Trials Call Center, Erlangen 91052, Germany

GSK Clinical Trials Call Center, Berlin 10178, Germany

GSK Clinical Trials Call Center, Berlin 14050, Germany

GSK Clinical Trials Call Center, Munich 81677, Germany

GSK Clinical Trials Call Center, Berlin 13086, Germany

GSK Clinical Trials Call Center, Potsdam 14469, Germany

GSK Clinical Trials Call Center, Berlin 13597, Germany

GSK Clinical Trials Call Center, Bruchsal 76646, Germany

GSK Clinical Trials Call Center, Lifford County Donegal, Ireland

GSK Clinical Trials Call Center, Kilkenny Kilkenny, Ireland

GSK Clinical Trials Call Center, Dublin Dublin 24, Ireland

GSK Clinical Trials Call Center, Dublin Dublin 4, Ireland

GSK Clinical Trials Call Center, Dublin Dublin 8, Ireland

GSK Clinical Trials Call Center, Riga LV1084, Latvia

GSK Clinical Trials Call Center, Valmiera LV4201, Latvia

GSK Clinical Trials Call Center, Limbazi LV4001, Latvia

GSK Clinical Trials Call Center, Riga LV1002, Latvia

GSK Clinical Trials Call Center, Skopje 9100, Macedonia, The Former Yugoslav Republic of

GSK Clinical Trials Call Center, Losser 7581 BV, Netherlands

GSK Clinical Trials Call Center, Voerendaal 6367 ED, Netherlands

GSK Clinical Trials Call Center, Eindhoven 5623 EJ, Netherlands

GSK Clinical Trials Call Center, Malden 4921 BC, Netherlands

GSK Clinical Trials Call Center, Geldermalsen 4191 AH, Netherlands

GSK Clinical Trials Call Center, Rotterdam 3015, Netherlands

GSK Clinical Trials Call Center, Den Bosch 5211 NL, Netherlands

GSK Clinical Trials Call Center, Spijkenisse 3207 NB, Netherlands

GSK Clinical Trials Call Center, Heerlen 6418 PC, Netherlands

GSK Clinical Trials Call Center, Helmond 5707 HA, Netherlands

GSK Clinical Trials Call Center, BENNEBROEK 2121 BB, Netherlands

GSK Clinical Trials Call Center, Utrecht 6584, Netherlands

GSK Clinical Trials Call Center, Almelo 7609 PP, Netherlands

GSK Clinical Trials Call Center, Christchurch 4710, New Zealand

GSK Clinical Trials Call Center, Grafton 92024, New Zealand

GSK Clinical Trials Call Center, Otahuhu 93311, New Zealand

GSK Clinical Trials Call Center, Galdakao 48960, Spain

GSK Clinical Trials Call Center, Gran Canarias 35020, Spain

GSK Clinical Trials Call Center, Barcelona 08221, Spain

GSK Clinical Trials Call Center, Alcorcon 28922, Spain

GSK Clinical Trials Call Center, La Coruna 15006, Spain

GSK Clinical Trials Call Center, Valencia 46017, Spain

GSK Clinical Trials Call Center, Lugo 27004, Spain

GSK Clinical Trials Call Center, Barcelona 08003, Spain

GSK Clinical Trials Call Center, Madrid 28041, Spain

GSK Clinical Trials Call Center, Madrid 28006, Spain

GSK Clinical Trials Call Center, Barry CF63 4HP, United Kingdom

GSK Clinical Trials Call Center, Cardiff CF4 9BB, United Kingdom

GSK Clinical Trials Call Center, Cardiff CF23 5SY, United Kingdom

GSK Clinical Trials Call Center, Aldershot GU12 5BA, United Kingdom

GSK Clinical Trials Call Center, Cambridge CB3 9MS, United Kingdom

GSK Clinical Trials Call Center, Manchester M23 9LT, United Kingdom

GSK Clinical Trials Call Center, Calgary, Alberta T2N 4N1, Canada

GSK Clinical Trials Call Center, Maple Ridge, British Columbia V2X 2L5, Canada

GSK Clinical Trials Call Center, Vancouver, British Columbia V5Z 3J5, Canada

GSK Clinical Trials Call Center, Blackpool, Cork Cork, Ireland

GSK Clinical Trials Call Center, Saffron Walden, Essex CB10 1EJ, United Kingdom

GSK Clinical Trials Call Center, Blackpool, Lancashire FY4 3AD, United Kingdom

GSK Clinical Trials Call Center, Blackpool, Lancashire FY1 6JW, United Kingdom

GSK Clinical Trials Call Center, Fleetwood, Lancashire RY7 7DG, United Kingdom

GSK Clinical Trials Call Center, Winnipeg, Manitoba R2H 2A6, Canada

GSK Clinical Trials Call Center, Balmain, New South Wales NSW2041, Australia

GSK Clinical Trials Call Center, Brampton, Ontario L6Y 2E6, Canada

GSK Clinical Trials Call Center, Hamilton, Ontario L8N 3Z5, Canada

GSK Clinical Trials Call Center, Mississauga, Ontario L5M 2V8, Canada

GSK Clinical Trials Call Center, New Brunswick, Ontario E2M 3W5, Canada

GSK Clinical Trials Call Center, Mississauga, Ontario L5H 1C5, Canada

GSK Clinical Trials Call Center, Peterborough, Ontario K9J 7B3, Canada

GSK Clinical Trials Call Center, Montreal, Quebec H5J 1C5, Canada

GSK Clinical Trials Call Center, Montreal, Quebec H3G 1A4, Canada

GSK Clinical Trials Call Center, Inala, Queensland QLD4077, Australia

GSK Clinical Trials Call Center, Kippa Ring, Queensland QLD4021, Australia

Starting date: November 2002
Last updated: May 25, 2007