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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salmeterol/fluticasone propionate or formoterol/budesonide | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean percentage of symptom-free days over a 52-week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Balmain | New South Wales | 2041 | Australia | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. | ||
| 15922813 | Result | 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/budesonide in adults with persistent asthma. Clin Ther. 2005 Apr;27(4):393-406. doi: 10.1016/j.clinthera.2005.03.006. | |
| Result | 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. | ||
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| SAM40056 | Informed Consent Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| Brisbane |
| Queensland |
| 4077 |
| Australia |
| GSK Investigational Site | Kippa-Ring | Queensland | 4021 | Australia |
| GSK Investigational Site | Toorak Gardens | South Australia | 5065 | Australia |
| GSK Investigational Site | Linz | A-4020 | Austria |
| GSK Investigational Site | Vienna | A-1030 | Austria |
| GSK Investigational Site | Vienna | A-1120 | Austria |
| GSK Investigational Site | Vienna | A-1210 | Austria |
| GSK Investigational Site | Aalst | 9300 | Belgium |
| GSK Investigational Site | Ath | 7800 | Belgium |
| GSK Investigational Site | Gilly | 6060 | Belgium |
| GSK Investigational Site | Hornu | 7301 | 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 | Calgary | Alberta | T2N 4N1 | Canada |
| GSK Investigational Site | Maple Ridge | British Columbia | V2X 2L5 | Canada |
| GSK Investigational Site | Vancouver | British Columbia | V5Z 3J5 | Canada |
| GSK Investigational Site | Winnipeg | Manitoba | R2H 2A6 | Canada |
| GSK Investigational Site | Saint John | New Brunswick | E2M 3W5 | Canada |
| 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 | 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 | Jakobstad | 68600 | Finland |
| GSK Investigational Site | Joensuu | 80100 | Finland |
| GSK Investigational Site | Lahti | 15850 | Finland |
| GSK Investigational Site | Raahe | 92100 | Finland |
| GSK Investigational Site | Tampere | 33520 | Finland |
| GSK Investigational Site | Varkaus | 78300 | Finland |
| GSK Investigational Site | Bruchsal | Baden-Wurttemberg | 76646 | Germany |
| GSK Investigational Site | Lahr | Baden-Wurttemberg | 77933 | Germany |
| GSK Investigational Site | Augsburg | Bavaria | 86150 | Germany |
| GSK Investigational Site | Erlangen | Bavaria | 91052 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81677 | Germany |
| GSK Investigational Site | Potsdam | Brandenburg | 14469 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10178 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 10717 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 13086 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 13187 | Germany |
| GSK Investigational Site | Berlin | State of Berlin | 13353 | Germany |
| GSK Investigational Site | Berlin | State of 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 | Limbaži | 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 | '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 | Skopje | 9100 | North Macedonia |
| GSK Investigational Site | A Coruña | 15006 | Spain |
| GSK Investigational Site | Alcorcón | 28922 | Spain |
| GSK Investigational Site | Barcelona | 08003 | Spain |
| GSK Investigational Site | Barcelona | 08221 | Spain |
| GSK Investigational Site | Galdakano | 48960 | 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 | Málaga | 29400 | Spain |
| GSK Investigational Site | Valencia | 46017 | Spain |
| 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 | Fleetwood | FY7 6HD | United Kingdom |
| GSK Investigational Site | Fleetwood | FY7 7DG | United Kingdom |
| Result |
| Price DB, Williams AE, Yoxall S. Salmeterol/fluticasone stable-dose treatment compared with formoterol/budesonide adjustable maintenance dosing: impact on health-related quality of life. Respir Res. 2007 Jul 4;8(1):46. doi: 10.1186/1465-9921-8-46. |
For additional information about this study please refer to the GSK Clinical Study Register |
| SAM40056 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SAM40056 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SAM40056 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SAM40056 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SAM40056 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| SAM40056 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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