Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets

details{'conditions': ['Asthma'], 'countries': ['Argentina', 'Colombia', 'Costa Rica', 'Mexico', 'Peru', 'Turkey (Türkiye)', 'Venezuela'], 'interventions': [{'name': 'montelukast (5mg QD)', 'type': 'DRUG', 'description': None}, {'name': 'Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID)', 'type': 'DRUG', 'description': None}], 'sponsors': [{'name': 'GlaxoSmithKline', 'role': 'lead', 'agency_class': 'INDUSTRY'}], 'facilities': [{'zip': '3000', 'city': 'Santa Fe', 'name': 'GSK Investigational Site', 'state': 'Santa Fe Province', 'country': 'Argentina'}, {'zip': 'C1121ABE', 'city': 'Buenos Aires', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Argentina'}, {'zip': 'C1424BSF', 'city': 'Capital Federal-Buenos Aires', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Argentina'}, {'zip': '11001000', 'city': 'Bogotá', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Colombia'}, {'zip': '76001000', 'city': 'Cali', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Colombia'}, {'zip': '05001000', 'city': 'Medellín', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Colombia'}, {'zip': None, 'city': 'San José', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Costa Rica'}, {'zip': '31020', 'city': 'Chihuahua City', 'name': 'GSK Investigational Site', 'state': 'Chihuahua', 'country': 'Mexico'}, {'zip': '44340', 'city': 'Guadalajara', 'name': 'GSK Investigational Site', 'state': 'Jalisco', 'country': 'Mexico'}, {'zip': '64460', 'city': 'Monterrey', 'name': 'GSK Investigational Site', 'state': 'Nuevo León', 'country': 'Mexico'}, {'zip': '03020', 'city': 'Mexico City', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Mexico'}, {'zip': '14080', 'city': 'Mexico City', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Mexico'}, {'zip': '04530', 'city': 'México', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Mexico'}, {'zip': '6720', 'city': 'México', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Mexico'}, {'zip': 'Lima 1', 'city': 'Lima', 'name': 'GSK Investigational Site', 'state': 'Lima Province', 'country': 'Peru'}, {'zip': 'Lima 27', 'city': 'Lima', 'name': 'GSK Investigational Site', 'state': 'Lima Province', 'country': 'Peru'}, {'zip': '1330', 'city': 'Adana', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Turkey (Türkiye)'}, {'zip': '6100', 'city': 'Ankara', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Turkey (Türkiye)'}, {'zip': '7070', 'city': 'Antalya', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Turkey (Türkiye)'}, {'zip': '16059', 'city': 'Bursa', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Turkey (Türkiye)'}, {'zip': '34303', 'city': 'Istanbul', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Turkey (Türkiye)'}, {'zip': '34668', 'city': 'Istanbul', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Turkey (Türkiye)'}, {'zip': '35100', 'city': 'Izmir', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Turkey (Türkiye)'}, {'zip': '1010', 'city': 'Caracas', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Venezuela'}, {'zip': '1060', 'city': 'Caracas', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Venezuela'}, {'zip': '1080', 'city': 'Caracas', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Venezuela'}], 'outcomes': [], 'brief_summary': "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.", 'study_type': 'INTERVENTIONAL', 'source_organization': 'GlaxoSmithKline', 'results_first_posted_date': None, 'has_results_basis': 'results_first_posted_date'}→{'conditions': ['Asthma'], 'countries': ['Argentina', 'Colombia', 'Costa Rica', 'Mexico', 'Peru', 'Turkey (Türkiye)', 'Venezuela'], 'interventions': [{'name': 'montelukast (5mg QD)', 'type': 'DRUG', 'description': None, 'other_names': [], 'design_groups': []}, {'name': 'Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID)', 'type': 'DRUG', 'description': None, 'other_names': ['montelukast (5mg QD)'], 'design_groups': []}], 'composition_semantics': 'study_intervention_labels_not_product_formula', 'sponsors': [{'name': 'GlaxoSmithKline', 'role': 'lead', 'agency_class': 'INDUSTRY'}], 'facilities': [{'zip': '3000', 'city': 'Santa Fe', 'name': 'GSK Investigational Site', 'state': 'Santa Fe Province', 'country': 'Argentina'}, {'zip': 'C1121ABE', 'city': 'Buenos Aires', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Argentina'}, {'zip': 'C1424BSF', 'city': 'Capital Federal-Buenos Aires', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Argentina'}, {'zip': '11001000', 'city': 'Bogotá', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Colombia'}, {'zip': '76001000', 'city': 'Cali', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Colombia'}, {'zip': '05001000', 'city': 'Medellín', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Colombia'}, {'zip': None, 'city': 'San José', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Costa Rica'}, {'zip': '31020', 'city': 'Chihuahua City', 'name': 'GSK Investigational Site', 'state': 'Chihuahua', 'country': 'Mexico'}, {'zip': '44340', 'city': 'Guadalajara', 'name': 'GSK Investigational Site', 'state': 'Jalisco', 'country': 'Mexico'}, {'zip': '64460', 'city': 'Monterrey', 'name': 'GSK Investigational Site', 'state': 'Nuevo León', 'country': 'Mexico'}, {'zip': '03020', 'city': 'Mexico City', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Mexico'}, {'zip': '14080', 'city': 'Mexico City', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Mexico'}, {'zip': '04530', 'city': 'México', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Mexico'}, {'zip': '6720', 'city': 'México', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Mexico'}, {'zip': 'Lima 1', 'city': 'Lima', 'name': 'GSK Investigational Site', 'state': 'Lima Province', 'country': 'Peru'}, {'zip': 'Lima 27', 'city': 'Lima', 'name': 'GSK Investigational Site', 'state': 'Lima Province', 'country': 'Peru'}, {'zip': '1330', 'city': 'Adana', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Turkey (Türkiye)'}, {'zip': '6100', 'city': 'Ankara', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Turkey (Türkiye)'}, {'zip': '7070', 'city': 'Antalya', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Turkey (Türkiye)'}, {'zip': '16059', 'city': 'Bursa', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Turkey (Türkiye)'}, {'zip': '34303', 'city': 'Istanbul', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Turkey (Türkiye)'}, {'zip': '34668', 'city': 'Istanbul', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Turkey (Türkiye)'}, {'zip': '35100', 'city': 'Izmir', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Turkey (Türkiye)'}, {'zip': '1010', 'city': 'Caracas', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Venezuela'}, {'zip': '1060', 'city': 'Caracas', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Venezuela'}, {'zip': '1080', 'city': 'Caracas', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Venezuela'}], 'outcomes': [], 'brief_summary': "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.", 'study_type': 'INTERVENTIONAL', 'source_organization': 'GlaxoSmithKline', 'results_first_posted_date': None, 'has_results_basis': 'results_first_posted_date', 'start_date_type': 'ACTUAL', 'start_month_year': '2005-10', 'start_date_precision': 'month', 'completion_date_type': 'ACTUAL', 'completion_month_year': '2007-04', 'completion_date_precision': 'month', 'primary_completion_date': '2007-04-30', 'primary_completion_month_year': '2007-04', 'primary_completion_date_precision': 'month', 'primary_completion_date_type': 'ACTUAL', 'intervention_component_groups': [['unmapped:montelukast-5mg-qd'], ['salmeterol', 'unmapped:100mcg-bid', 'unmapped:fluticasone-propionate-inhalation-powder-50']], 'intervention_normalization': [{'name': 'montelukast (5mg QD)', 'selected_label': 'montelukast (5mg QD)', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['unmapped:montelukast-5mg-qd'], 'unverified_label_components': ['unmapped:montelukast-5mg-qd'], 'items': [{'original': 'montelukast (5mg QD)', 'component': 'unmapped:montelukast-5mg-qd', 'status': 'unresolved', 'method': 'no_verified_mapping'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}, {'name': 'Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID)', 'selected_label': 'Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID)', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['salmeterol', 'unmapped:100mcg-bid', 'unmapped:fluticasone-propionate-inhalation-powder-50'], 'unverified_label_components': ['unmapped:100mcg-bid', 'unmapped:fluticasone-propionate-inhalation-powder-50'], 'items': [{'original': 'Salmeterol', 'component': 'salmeterol', 'status': 'resolved', 'method': 'versioned_lexicon'}, {'original': 'Fluticasone propionate Inhalation Powder (50', 'component': 'unmapped:fluticasone-propionate-inhalation-powder-50', 'status': 'unresolved', 'method': 'no_verified_mapping'}, {'original': '100mcg BID)', 'component': 'unmapped:100mcg-bid', 'status': 'unresolved', 'method': 'no_verified_mapping'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}]}