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This double-blind, stratified, parallel group study is to determine whether aiming for 'Total control' results in better airway hyper-responsiveness than maintaining the treatment level at which 'Well-controlled' asthma was achieved. The primary endpoint is the mean change in PC20 methacholine. Well controlled subjects (as assessed after a 12 week run-in period) will enter a 24 week treatment period during which they will record PEF(Peak Expiratory Flow), symptoms, rescue beta2-agonist use over 24 hours, night time awakenings, asthma exacerbations, emergency visits due to asthma and Adverse Events. At every visit lung function measurements and airway hyper-responsiveness will be measured.
A multi-centre, randomised, double blind, stratified, and parallel group study to evaluate whether a treatment strategy based on aiming for 'Total control' results in better airway hyper-responsiveness than a treatment strategy based on maintaining the treatment level at which 'Well-controlled' asthma was achieved.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salmeterol/fluticasone propionate combination | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in PC20 methacholine (as a measure of airway hyper-responsiveness) following 24 weeks of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of 'Totally-controlled' and Well-controlled patients at the end of the run-in and treatment period according to the GOAL criteria. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials, MD | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Ghent | 9000 | Belgium | |||
| GSK Investigational Site |
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| Liège |
| 4000 |
| Belgium |
| GSK Investigational Site | Tartu | 51014 | Estonia |
| GSK Investigational Site | Jyväskylä | 40100 | Finland |
| GSK Investigational Site | Tampere | 33100 | Finland |
| GSK Investigational Site | Lille | 59042 | France |
| GSK Investigational Site | Montpellier | 34295 | France |
| GSK Investigational Site | Poitiers | 86000 cedex | France |
| GSK Investigational Site | Sinsheim | Baden-Wurttemberg | 74889 | Germany |
| GSK Investigational Site | Bonn | North Rhine-Westphalia | 53123 | Germany |
| GSK Investigational Site | Berlin | 10559 | Germany |
| GSK Investigational Site | Berlin | 13353 | Germany |
| GSK Investigational Site | Berlin | 13359 | Germany |
| GSK Investigational Site | Foggia | Apulia | 71100 | Italy |
| GSK Investigational Site | Cagliari | Sardinia | 09126 | Italy |
| GSK Investigational Site | Torrette (AN) | The Marches | 60020 | Italy |
| GSK Investigational Site | Pisa | Tuscany | 56124 | Italy |
| GSK Investigational Site | Bussolengo (VR) | Veneto | 37012 | Italy |
| GSK Investigational Site | Salerno | 84100 | Italy |
| GSK Investigational Site | Riga | LV 1003 | Latvia |
| GSK Investigational Site | Riga | LV 1035 | Latvia |
| GSK Investigational Site | Breda | 4819 EV | Netherlands |
| GSK Investigational Site | Groningen | 9721 SW | Netherlands |
| GSK Investigational Site | Harderwijk | 3844 DG | Netherlands |
| GSK Investigational Site | Helmond | 5707 HA | Netherlands |
| GSK Investigational Site | Hoorn | 1624 NP | Netherlands |
| GSK Investigational Site | Nieuwegein | 3435 CM | Netherlands |
| GSK Investigational Site | Veldhoven | 5504 DB | Netherlands |
| GSK Investigational Site | Barcelona | 08022 | Spain |
| GSK Investigational Site | Madrid | 28006 | Spain |
| GSK Investigational Site | Tarrasa, Barcelona | 08221 | Spain |
| GSK Investigational Site | Valencia | 46017 | Spain |
| GSK Investigational Site | Gothenburg | SE-413 45 | Sweden |
| GSK Investigational Site | Linköping | SE-585 81 | Sweden |
| GSK Investigational Site | Lund | SE-221 85 | Sweden |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D012130 | Respiratory Hypersensitivity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| ID | Term |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000068298 | Fluticasone |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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