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This study is being conducted to demonstrate the superior clinical effectiveness of Salmeterol/Fluticasone Propionate compared to montelukast in the management of persistent asthma in children aged 6-14 years, and to assess the effect of each treatment [Salmeterol/Fluticasone Propionate (50/100 mcg) and montelukast (5 mg)] on lung function, asthma control, Health Outcomes including the child's quality of life as measured by Paediatric Asthma Quality of Life Questionnaire (PAQLQ) and the caregiver's quality of life as measured by Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) at selected centers where a valid translation is available.
Pediatric Asthma Clinical Effectiveness study (PEACE). A Randomized, Double-Blind, Double Dummy, Parallel Group comparative clinical study of Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID) via DISKUS† with Oral montelukast (5mg QD) Chewable Tablets in Children 6-14 years of Age with Persistent Asthma
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| montelukast (5mg QD) | Drug | |||
| Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mean morning PEFR (Peak Expiratory Flow Rate) at endpoint. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline to endpoint of:morning pre-dose FEV1 (Forced expiratory volume) symptom free 24 hour-periods rescue medication-free 24 hour-periods mean evening PEFR |
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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 | Santa Fe | Santa Fe Province | 3000 | Argentina | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18803991 | Background | Maspero J, Guerra F, Cuevas F, Gutierrez JP, Soto-Ramos M, Anderton S, Mechali D, Chan R, Pedersen S. Efficacy and tolerability of salmeterol/fluticasone propionate versus montelukast in childhood asthma: A prospective, randomized, double-blind, double-dummy, parallel-group study. Clin Ther. 2008 Aug;30(8):1492-504. doi: 10.1016/j.clinthera.2008.07.018. |
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| Buenos Aires |
| C1121ABE |
| Argentina |
| GSK Investigational Site | Capital Federal-Buenos Aires | C1424BSF | Argentina |
| GSK Investigational Site | Bogotá | 11001000 | Colombia |
| GSK Investigational Site | Cali | 76001000 | Colombia |
| GSK Investigational Site | Medellín | 05001000 | Colombia |
| GSK Investigational Site | San José | Costa Rica |
| GSK Investigational Site | Chihuahua City | Chihuahua | 31020 | Mexico |
| GSK Investigational Site | Guadalajara | Jalisco | 44340 | Mexico |
| GSK Investigational Site | Monterrey | Nuevo León | 64460 | Mexico |
| GSK Investigational Site | Mexico City | 03020 | Mexico |
| GSK Investigational Site | Mexico City | 14080 | Mexico |
| GSK Investigational Site | México | 04530 | Mexico |
| GSK Investigational Site | México | 6720 | Mexico |
| GSK Investigational Site | Lima | Lima Province | Lima 1 | Peru |
| GSK Investigational Site | Lima | Lima Province | Lima 27 | Peru |
| GSK Investigational Site | Adana | 1330 | Turkey (Türkiye) |
| GSK Investigational Site | Ankara | 6100 | Turkey (Türkiye) |
| GSK Investigational Site | Antalya | 7070 | Turkey (Türkiye) |
| GSK Investigational Site | Bursa | 16059 | Turkey (Türkiye) |
| GSK Investigational Site | Istanbul | 34303 | Turkey (Türkiye) |
| GSK Investigational Site | Istanbul | 34668 | Turkey (Türkiye) |
| GSK Investigational Site | Izmir | 35100 | Turkey (Türkiye) |
| GSK Investigational Site | Caracas | 1010 | Venezuela |
| GSK Investigational Site | Caracas | 1060 | Venezuela |
| GSK Investigational Site | Caracas | 1080 | Venezuela |
| 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 |
|---|---|
| C093875 | montelukast |
| D000068299 | Salmeterol Xinafoate |
| C494814 | BID protein, human |
| ID | Term |
|---|---|
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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