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| ID | Type | Description | Link |
|---|---|---|---|
| SER9702/CATO |
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This study was designed to evaluate if, in children with asthma, a stepwise treatment (five levels varying from once daily fluticasone propionate 100mcg until twice daily a fixed combination of salmeterol and fluticasone propionate 50/500 mcg) based on symptom scores alone results in a sub-optimal treatment when compared to treatment based on cumulative symptom scores and bronchial hyperresponsiveness (PD20 methacholine).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salmeterol/Fluticasone propionate combination product | Drug | |||
| Fluticasone propionate | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Asthma symptom free days during the last 12 weeks of the treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| Bronchial hyperresponsiveness, determined by PD20 methacholine at the end of the study. |
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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 | Alkmaar | 1815 JD | Netherlands | |||
| GSK Investigational Site |
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| Almere Stad |
| 1315 RA |
| Netherlands |
| GSK Investigational Site | Amsterdam | 1081 HV | Netherlands |
| GSK Investigational Site | Amsterdam | 1105 AZ | Netherlands |
| GSK Investigational Site | Breda | 4818 CK | Netherlands |
| GSK Investigational Site | Eindhoven | 5623 EJ | Netherlands |
| GSK Investigational Site | Groningen | 9713 GZ | Netherlands |
| GSK Investigational Site | Hilversum | 1213 VX | Netherlands |
| GSK Investigational Site | Leiden | 2333 ZA | Netherlands |
| GSK Investigational Site | Maastricht | 6229 HX | Netherlands |
| GSK Investigational Site | Rotterdam | 3015 GD | Netherlands |
| GSK Investigational Site | Sittard | 6131 BK | Netherlands |
| GSK Investigational Site | The Hague | 2566 MJ | Netherlands |
| GSK Investigational Site | Utrecht | 3584 EA | Netherlands |
| GSK Investigational Site | Veldhoven | 5504 DB | Netherlands |
| GSK Investigational Site | Zwolle | 8011 JW | Netherlands |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D016535 | Bronchial Hyperreactivity |
| 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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