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The primary study objective is to demonstrate the clinical effectiveness of SERETIDE therapy compared to the current care in management of moderate to severe persistent asthma patients in Korea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sal/FP 50/250mcg | Active Comparator | SERETIDE 50/250 |
|
| Sal/FP 50/500mcg | Active Comparator | SERETIDE 50/500 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salmeterol/ fluticasone propionate | Drug | 2 active arms (parellel group) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy endpoint for this trial is mean morning PEFR LOCF at 52 weeks as collected in diary cards over the last 2 weeks preceding the 52 weeks visit. | 52 weeks after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary measures of efficacy consist of clinical efficacy and health outcome measurements. | 52 weeks after randomization |
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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 | Anyang-si | 431-070 | South Korea | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19032138 | Background | Jung KS, Uh ST, Lee YC, Shim JJ, Park SK, Williams AE, Chan R. Comparison of the clinical efficacy and safety of salmeterol/fluticasone propionate versus current care in the management of persistent asthma in Korea. Curr Med Res Opin. 2008 Dec;24(12):3571-82. doi: 10.1185/03007990802588737. |
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| Busan |
| South Korea |
| GSK Investigational Site | Jeonju | South Korea |
| GSK Investigational Site | Junjoo-Si | South Korea |
| GSK Investigational Site | Kyungki-Do Anyang-si | South Korea |
| GSK Investigational Site | Kyungki-Do | South Korea |
| GSK Investigational Site | Pusan | 602-739 | South Korea |
| GSK Investigational Site | Pusan | South Korea |
| GSK Investigational Site | Seoul | 120-752 | South Korea |
| GSK Investigational Site | Seoul | 140-743 | South Korea |
| GSK Investigational Site | Seoul | 152-703 | South Korea |
| GSK Investigational Site | Seoul | South Korea |
| 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 |
|---|---|
| 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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