Study of Mometasone Furoate/Formoterol Combination and Fluticasone/Salmeterol in Persistent Asthmatics Previously Treated With Inhaled Glucocorticosteroids (P04139)
Нормализованный состав
fluticasone
10 mcg bid
50 mcg bid
mometasone furoate combination mdi 200
mometasone furoate combination mdi 400
salmeterol 250
salmeterol 500
+4
Завершено
Первоисточник ↗
Информация
Изменилось с прошлой загрузки
Информация
Связь с регистрацией не подтверждена
Факт источника
Основные сведения
- Компания / организация
- Organon and Co
- Протокол
- P04139
- Фаза
- PHASE3
- Статус
- Завершено
- Дата начала
- 30.06.2006
- Дата завершения
- 30.11.2007
- Участники
- 404
- Результаты
- Опубликованы
Нормализация
Исходный и нормализованный состав
Факт источника
mometasone furoate combination MDI 200 + 10 mcg BID + mometasone furoate combination MDI 400 + 10 mcg BID + Fluticasone + Salmeterol 250 + 50 mcg BID + Fluticasone + Salmeterol 500 + 50 mcg BID
Значение сохранено без подмены исходного факта.
Нормализованное значение
fluticasone
10 mcg bid
50 mcg bid
mometasone furoate combination mdi 200
mometasone furoate combination mdi 400
salmeterol 250
salmeterol 500
Используется для поиска, сравнения и связывания.
Сопоставление
Связанные записи
История
Изменения относительно загрузок
details{'conditions': ['Asthma'], 'countries': [], 'interventions': [{'name': 'mometasone furoate combination MDI 200/10 mcg BID', 'type': 'DRUG', 'description': 'MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year'}, {'name': 'mometasone furoate combination MDI 400/10 mcg BID', 'type': 'DRUG', 'description': 'MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year'}, {'name': 'Fluticasone/Salmeterol 250/50 mcg BID', 'type': 'DRUG', 'description': 'F/SC 250/50 twice daily for 1 year'}, {'name': 'Fluticasone/Salmeterol 500/50 mcg BID', 'type': 'DRUG', 'description': 'F/SC 500/50 twice daily for 1 year'}], 'sponsors': [{'name': 'Organon and Co', 'role': 'lead', 'agency_class': 'INDUSTRY'}], 'facilities': [], 'outcomes': [{'type': 'PRIMARY', 'title': 'The Number of All Randomized Subjects Reporting Adverse Events (AEs).', 'time_frame': '1 year', 'description': 'AEs that are considered Related, Severe, and Serious, as determined by the investigator and using specific criteria defined in the protocol, are included in the primary results.'}], 'brief_summary': 'The purpose of this study is to evaluate the long-term safety of mometasone furoate/formoterol (MF/F) metered dose inhaler (MDI) 200/10 mcg twice-a-day (BID) and MF/F MDI 400/10 mcg BID and two doses of fluticasone/salmeterol combination (F/SC) (250/50 mcg BID and 500/50 mcg BID) in subjects with persistent asthma who require maintenance treatment on inhaled glucocorticosteroids (ICS); evaluator-blind.\n\nIn addition, the extrapulmonary effects on 24-hour plasma cortisol area under curve (AUC), of MF/F MDI 200/10 mcg BID, MF/F MDI 400/10 mcg BID, F/SC MDI 250/50 mcg BID, and F/SC MDI 500/50 mcg BID will be evaluated.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'Organon and Co', 'results_first_posted_date': '2010-08-12', 'has_results_basis': 'results_first_posted_date'}→{'conditions': ['Asthma'], 'countries': [], 'interventions': [{'name': 'mometasone furoate combination MDI 200/10 mcg BID', 'type': 'DRUG', 'description': 'MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year', 'other_names': ['SCH 418131'], 'design_groups': [{'id': 421399939, 'type': 'EXPERIMENTAL', 'title': 'MF/F 200/10 mcg BID', 'description': None}]}, {'name': 'mometasone furoate combination MDI 400/10 mcg BID', 'type': 'DRUG', 'description': 'MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year', 'other_names': ['SCH 418131'], 'design_groups': [{'id': 421399940, 'type': 'EXPERIMENTAL', 'title': 'MF/F 400/10 mcg BID', 'description': None}]}, {'name': 'Fluticasone/Salmeterol 250/50 mcg BID', 'type': 'DRUG', 'description': 'F/SC 250/50 twice daily for 1 year', 'other_names': ['Seretide'], 'design_groups': [{'id': 421399941, 'type': 'ACTIVE_COMPARATOR', 'title': 'F/SC 250/50 mcg BID', 'description': None}]}, {'name': 'Fluticasone/Salmeterol 500/50 mcg BID', 'type': 'DRUG', 'description': 'F/SC 500/50 twice daily for 1 year', 'other_names': ['Seretide'], 'design_groups': [{'id': 421399942, 'type': 'ACTIVE_COMPARATOR', 'title': 'F/SC 500/50 mcg BID', 'description': None}]}], 'composition_semantics': 'study_intervention_labels_not_product_formula', 'sponsors': [{'name': 'Organon and Co', 'role': 'lead', 'agency_class': 'INDUSTRY'}], 'facilities': [], 'outcomes': [{'type': 'PRIMARY', 'title': 'The Number of All Randomized Subjects Reporting Adverse Events (AEs).', 'time_frame': '1 year', 'description': 'AEs that are considered Related, Severe, and Serious, as determined by the investigator and using specific criteria defined in the protocol, are included in the primary results.'}], 'brief_summary': 'The purpose of this study is to evaluate the long-term safety of mometasone furoate/formoterol (MF/F) metered dose inhaler (MDI) 200/10 mcg twice-a-day (BID) and MF/F MDI 400/10 mcg BID and two doses of fluticasone/salmeterol combination (F/SC) (250/50 mcg BID and 500/50 mcg BID) in subjects with persistent asthma who require maintenance treatment on inhaled glucocorticosteroids (ICS); evaluator-blind.\n\nIn addition, the extrapulmonary effects on 24-hour plasma cortisol area under curve (AUC), of MF/F MDI 200/10 mcg BID, MF/F MDI 400/10 mcg BID, F/SC MDI 250/50 mcg BID, and F/SC MDI 500/50 mcg BID will be evaluated.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'Organon and Co', 'results_first_posted_date': '2010-08-12', 'has_results_basis': 'results_first_posted_date', 'start_date_type': None, 'start_month_year': '2006-06', 'start_date_precision': 'month', 'completion_date_type': 'ACTUAL', 'completion_month_year': '2007-11', 'completion_date_precision': 'month', 'primary_completion_date': '2007-11-30', 'primary_completion_month_year': '2007-11', 'primary_completion_date_precision': 'month', 'primary_completion_date_type': 'ACTUAL', 'intervention_component_groups': [['unmapped:10-mcg-bid', 'unmapped:mometasone-furoate-combination-mdi-200'], ['unmapped:10-mcg-bid', 'unmapped:mometasone-furoate-combination-mdi-400'], ['fluticasone', 'unmapped:50-mcg-bid', 'unmapped:salmeterol-250'], ['fluticasone', 'unmapped:50-mcg-bid', 'unmapped:salmeterol-500']], 'intervention_normalization': [{'name': 'mometasone furoate combination MDI 200/10 mcg BID', 'selected_label': 'mometasone furoate combination MDI 200/10 mcg BID', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['unmapped:10-mcg-bid', 'unmapped:mometasone-furoate-combination-mdi-200'], 'unverified_label_components': ['unmapped:10-mcg-bid', 'unmapped:mometasone-furoate-combination-mdi-200'], 'items': [{'original': 'mometasone furoate combination MDI 200', 'component': 'unmapped:mometasone-furoate-combination-mdi-200', 'status': 'unresolved', 'method': 'no_verified_mapping'}, {'original': '10 mcg BID', 'component': 'unmapped:10-mcg-bid', 'status': 'unresolved', 'method': 'no_verified_mapping'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}, {'name': 'mometasone furoate combination MDI 400/10 mcg BID', 'selected_label': 'mometasone furoate combination MDI 400/10 mcg BID', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['unmapped:10-mcg-bid', 'unmapped:mometasone-furoate-combination-mdi-400'], 'unverified_label_components': ['unmapped:10-mcg-bid', 'unmapped:mometasone-furoate-combination-mdi-400'], 'items': [{'original': 'mometasone furoate combination MDI 400', 'component': 'unmapped:mometasone-furoate-combination-mdi-400', 'status': 'unresolved', 'method': 'no_verified_mapping'}, {'original': '10 mcg BID', 'component': 'unmapped:10-mcg-bid', 'status': 'unresolved', 'method': 'no_verified_mapping'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}, {'name': 'Fluticasone/Salmeterol 250/50 mcg BID', 'selected_label': 'Fluticasone/Salmeterol 250/50 mcg BID', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['fluticasone', 'unmapped:50-mcg-bid', 'unmapped:salmeterol-250'], 'unverified_label_components': ['unmapped:50-mcg-bid', 'unmapped:salmeterol-250'], 'items': [{'original': 'Fluticasone', 'component': 'fluticasone', 'status': 'resolved', 'method': 'versioned_lexicon'}, {'original': 'Salmeterol 250', 'component': 'unmapped:salmeterol-250', 'status': 'unresolved', 'method': 'no_verified_mapping'}, {'original': '50 mcg BID', 'component': 'unmapped:50-mcg-bid', 'status': 'unresolved', 'method': 'no_verified_mapping'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}, {'name': 'Fluticasone/Salmeterol 500/50 mcg BID', 'selected_label': 'Fluticasone/Salmeterol 500/50 mcg BID', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['fluticasone', 'unmapped:50-mcg-bid', 'unmapped:salmeterol-500'], 'unverified_label_components': ['unmapped:50-mcg-bid', 'unmapped:salmeterol-500'], 'items': [{'original': 'Fluticasone', 'component': 'fluticasone', 'status': 'resolved', 'method': 'versioned_lexicon'}, {'original': 'Salmeterol 500', 'component': 'unmapped:salmeterol-500', 'status': 'unresolved', 'method': 'no_verified_mapping'}, {'original': '50 mcg BID', 'component': 'unmapped:50-mcg-bid', 'status': 'unresolved', 'method': 'no_verified_mapping'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}]}