Airway Hyper-responsiveness Study In Asthma Using Salmeterol/Fluticasone Propionate Combination Product
Нормализованный состав
salmeterol
fluticasone propionate combination
COMPLETED
Первоисточник ↗
Информация
Изменилось с прошлой загрузки
Информация
Результаты не размещены (факт источника)
Информация
Связь с регистрацией не подтверждена
Факт источника
Основные сведения
- Компания / организация
- GlaxoSmithKline
- Протокол
- SAM49071
- Фаза
- PHASE4
- Статус
- COMPLETED
- Дата начала
- 30.11.2005
- Дата завершения
- 31.07.2007
- Участники
- 150
- Результаты
- Не найдены
Нормализация
Исходный и нормализованный состав
Факт источника
Salmeterol + fluticasone propionate combination
Значение сохранено без подмены исходного факта.
Нормализованное значение
salmeterol
fluticasone propionate combination
Используется для поиска, сравнения и связывания.
Сопоставление
Связанные записи
История
Изменения относительно загрузок
details{'conditions': ['Asthma'], 'countries': ['Belgium', 'Estonia', 'Finland', 'France', 'Germany', 'Italy', 'Latvia', 'Netherlands', 'Spain', 'Sweden'], 'interventions': [{'name': 'Salmeterol/fluticasone propionate combination', 'type': 'DRUG', 'description': None}], 'sponsors': [{'name': 'GlaxoSmithKline', 'role': 'lead', 'agency_class': 'INDUSTRY'}], 'facilities': [{'zip': '9000', 'city': 'Ghent', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': '4000', 'city': 'Liège', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': '51014', 'city': 'Tartu', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Estonia'}, {'zip': '40100', 'city': 'Jyväskylä', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Finland'}, {'zip': '33100', 'city': 'Tampere', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Finland'}, {'zip': '59042', 'city': 'Lille', 'name': 'GSK Investigational Site', 'state': None, 'country': 'France'}, {'zip': '34295', 'city': 'Montpellier', 'name': 'GSK Investigational Site', 'state': None, 'country': 'France'}, {'zip': '86000 cedex', 'city': 'Poitiers', 'name': 'GSK Investigational Site', 'state': None, 'country': 'France'}, {'zip': '74889', 'city': 'Sinsheim', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '53123', 'city': 'Bonn', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '10559', 'city': 'Berlin', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': '13353', 'city': 'Berlin', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': '13359', 'city': 'Berlin', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': '71100', 'city': 'Foggia', 'name': 'GSK Investigational Site', 'state': 'Apulia', 'country': 'Italy'}, {'zip': '09126', 'city': 'Cagliari', 'name': 'GSK Investigational Site', 'state': 'Sardinia', 'country': 'Italy'}, {'zip': '60020', 'city': 'Torrette (AN)', 'name': 'GSK Investigational Site', 'state': 'The Marches', 'country': 'Italy'}, {'zip': '56124', 'city': 'Pisa', 'name': 'GSK Investigational Site', 'state': 'Tuscany', 'country': 'Italy'}, {'zip': '37012', 'city': 'Bussolengo (VR)', 'name': 'GSK Investigational Site', 'state': 'Veneto', 'country': 'Italy'}, {'zip': '84100', 'city': 'Salerno', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Italy'}, {'zip': 'LV 1003', 'city': 'Riga', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Latvia'}, {'zip': 'LV 1035', 'city': 'Riga', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Latvia'}, {'zip': '4819 EV', 'city': 'Breda', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '9721 SW', 'city': 'Groningen', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '3844 DG', 'city': 'Harderwijk', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '5707 HA', 'city': 'Helmond', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '1624 NP', 'city': 'Hoorn', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '3435 CM', 'city': 'Nieuwegein', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '5504 DB', 'city': 'Veldhoven', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '08022', 'city': 'Barcelona', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Spain'}, {'zip': '28006', 'city': 'Madrid', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Spain'}, {'zip': '08221', 'city': 'Tarrasa, Barcelona', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Spain'}, {'zip': '46017', 'city': 'Valencia', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Spain'}, {'zip': 'SE-413 45', 'city': 'Gothenburg', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Sweden'}, {'zip': 'SE-585 81', 'city': 'Linköping', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Sweden'}, {'zip': 'SE-221 85', 'city': 'Lund', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Sweden'}], 'outcomes': [], 'brief_summary': "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.", 'study_type': 'INTERVENTIONAL', 'source_organization': 'GlaxoSmithKline', 'results_first_posted_date': None, 'has_results_basis': 'results_first_posted_date'}→{'conditions': ['Asthma'], 'countries': ['Belgium', 'Estonia', 'Finland', 'France', 'Germany', 'Italy', 'Latvia', 'Netherlands', 'Spain', 'Sweden'], 'interventions': [{'name': 'Salmeterol/fluticasone propionate combination', 'type': 'DRUG', 'description': None, 'other_names': [], 'design_groups': []}], 'composition_semantics': 'study_intervention_labels_not_product_formula', 'sponsors': [{'name': 'GlaxoSmithKline', 'role': 'lead', 'agency_class': 'INDUSTRY'}], 'facilities': [{'zip': '9000', 'city': 'Ghent', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': '4000', 'city': 'Liège', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Belgium'}, {'zip': '51014', 'city': 'Tartu', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Estonia'}, {'zip': '40100', 'city': 'Jyväskylä', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Finland'}, {'zip': '33100', 'city': 'Tampere', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Finland'}, {'zip': '59042', 'city': 'Lille', 'name': 'GSK Investigational Site', 'state': None, 'country': 'France'}, {'zip': '34295', 'city': 'Montpellier', 'name': 'GSK Investigational Site', 'state': None, 'country': 'France'}, {'zip': '86000 cedex', 'city': 'Poitiers', 'name': 'GSK Investigational Site', 'state': None, 'country': 'France'}, {'zip': '74889', 'city': 'Sinsheim', 'name': 'GSK Investigational Site', 'state': 'Baden-Wurttemberg', 'country': 'Germany'}, {'zip': '53123', 'city': 'Bonn', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '10559', 'city': 'Berlin', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': '13353', 'city': 'Berlin', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': '13359', 'city': 'Berlin', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Germany'}, {'zip': '71100', 'city': 'Foggia', 'name': 'GSK Investigational Site', 'state': 'Apulia', 'country': 'Italy'}, {'zip': '09126', 'city': 'Cagliari', 'name': 'GSK Investigational Site', 'state': 'Sardinia', 'country': 'Italy'}, {'zip': '60020', 'city': 'Torrette (AN)', 'name': 'GSK Investigational Site', 'state': 'The Marches', 'country': 'Italy'}, {'zip': '56124', 'city': 'Pisa', 'name': 'GSK Investigational Site', 'state': 'Tuscany', 'country': 'Italy'}, {'zip': '37012', 'city': 'Bussolengo (VR)', 'name': 'GSK Investigational Site', 'state': 'Veneto', 'country': 'Italy'}, {'zip': '84100', 'city': 'Salerno', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Italy'}, {'zip': 'LV 1003', 'city': 'Riga', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Latvia'}, {'zip': 'LV 1035', 'city': 'Riga', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Latvia'}, {'zip': '4819 EV', 'city': 'Breda', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '9721 SW', 'city': 'Groningen', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '3844 DG', 'city': 'Harderwijk', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '5707 HA', 'city': 'Helmond', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '1624 NP', 'city': 'Hoorn', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '3435 CM', 'city': 'Nieuwegein', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '5504 DB', 'city': 'Veldhoven', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '08022', 'city': 'Barcelona', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Spain'}, {'zip': '28006', 'city': 'Madrid', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Spain'}, {'zip': '08221', 'city': 'Tarrasa, Barcelona', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Spain'}, {'zip': '46017', 'city': 'Valencia', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Spain'}, {'zip': 'SE-413 45', 'city': 'Gothenburg', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Sweden'}, {'zip': 'SE-585 81', 'city': 'Linköping', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Sweden'}, {'zip': 'SE-221 85', 'city': 'Lund', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Sweden'}], 'outcomes': [], 'brief_summary': "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.", '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': '2005-11', 'start_date_precision': 'month', 'completion_date_type': 'ACTUAL', 'completion_month_year': '2007-07', 'completion_date_precision': 'month', 'primary_completion_date': '2007-07-31', 'primary_completion_month_year': '2007-07', 'primary_completion_date_precision': 'month', 'primary_completion_date_type': 'ACTUAL', 'intervention_component_groups': [['salmeterol', 'unmapped:fluticasone-propionate-combination']], 'intervention_normalization': [{'name': 'Salmeterol/fluticasone propionate combination', 'selected_label': 'Salmeterol/fluticasone propionate combination', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['salmeterol', 'unmapped:fluticasone-propionate-combination'], 'unverified_label_components': ['unmapped:fluticasone-propionate-combination'], 'items': [{'original': 'Salmeterol', 'component': 'salmeterol', 'status': 'resolved', 'method': 'versioned_lexicon'}, {'original': 'fluticasone propionate combination', 'component': 'unmapped:fluticasone-propionate-combination', 'status': 'unresolved', 'method': 'no_verified_mapping'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}]}