A Comparative Study To Determine If Motivating Asthma Education (Compliance Enhancement) Has An Effect On Asthma Control
Факт источника
Основные сведения
- Компания / организация
- GlaxoSmithKline
- Протокол
- ACE104325
- Фаза
- PHASE4
- Статус
- COMPLETED
- Дата начала
- 26.07.2005
- Дата завершения
- 13.06.2007
- Участники
- 274
- Результаты
- Не найдены
Нормализация
Исходный и нормализованный состав
Сопоставление
Связанные записи
История
Изменения относительно загрузок
details{'conditions': ['Asthma'], 'countries': ['Denmark', 'Switzerland'], 'interventions': [{'name': 'salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training', 'type': 'DRUG', 'description': 'Salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training will be provided to intervention group in Period 2.'}, {'name': 'salmeterol/fluticasone propionate 50/250 µg', 'type': 'DRUG', 'description': 'Salmeterol/fluticasone propionate 50/250 µg will be administered to control group in Period 2'}], 'sponsors': [{'name': 'GlaxoSmithKline', 'role': 'lead', 'agency_class': 'INDUSTRY'}], 'facilities': [{'zip': 'DK-9100', 'city': 'Aalborg', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Denmark'}, {'zip': 'DK-8000', 'city': 'Aarhus C', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Denmark'}, {'zip': '2650', 'city': 'Hvidovre', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Denmark'}, {'zip': '2400', 'city': 'København NV', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Denmark'}, {'zip': '4700', 'city': 'Næstved', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Denmark'}, {'zip': '5000', 'city': 'Odense C', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Denmark'}, {'zip': '5000', 'city': 'Aarau', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '4123', 'city': 'Allschwil', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '4001', 'city': 'Basel', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '4031', 'city': 'Basel', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '4053', 'city': 'Basel', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '4054', 'city': 'Basel', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '4058', 'city': 'Basel', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '3007', 'city': 'Bern', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '3011', 'city': 'Bern', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '3012', 'city': 'Bern', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '7502', 'city': 'Bever', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '4805', 'city': 'Brittnau', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '6532', 'city': 'Castione', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '3186', 'city': 'Düdingen', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '8132', 'city': 'Egg', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '8639', 'city': 'Faltigberg-Wald', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '6048', 'city': 'Horw', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '7250', 'city': 'Klosters Platz', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '6713', 'city': 'Malvaglia', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '6900', 'city': 'Massagno', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '6963', 'city': 'Pregassona', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '8266', 'city': 'Steckborn', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '3600', 'city': 'Thun', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '8636', 'city': 'Wald', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '8556', 'city': 'Wigoltingen', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '3076', 'city': 'Worb', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}], 'outcomes': [], 'brief_summary': 'This study will investigate whether study subjects with previously uncontrolled asthma treated with SERETIDE Diskus 50/250 CCI18781+GR33343 mcg twice a day can attain a level of Total Control of their condition and whether adherence to treatment can be enhanced by teaching the subjects. Two groups of equal size with identical medical treatment will be compared with each other, the test group receiving three training modules during study visits and the control group regular study visits only.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'GlaxoSmithKline', 'results_first_posted_date': None, 'has_results_basis': 'results_first_posted_date'}→{'conditions': ['Asthma'], 'countries': ['Denmark', 'Switzerland'], 'interventions': [{'name': 'salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training', 'type': 'DRUG', 'description': 'Salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training will be provided to intervention group in Period 2.', 'other_names': [], 'design_groups': [{'id': 421426096, 'type': 'EXPERIMENTAL', 'title': 'Interventional group: Period 2', 'description': 'Randomized subjects will receive salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training in Period 2'}]}, {'name': 'salmeterol/fluticasone propionate 50/250 µg', 'type': 'DRUG', 'description': 'Salmeterol/fluticasone propionate 50/250 µg will be administered to control group in Period 2', 'other_names': [], 'design_groups': [{'id': 421426097, 'type': 'ACTIVE_COMPARATOR', 'title': 'Control group: Period 2', 'description': 'Randomized subjects will receive salmeterol/fluticasone propionate 50/250 µg in treatment Period 2'}, {'id': 421426098, 'type': 'EXPERIMENTAL', 'title': 'Subjects receiving salmeterol/fluticasone propionate: Period 1', 'description': 'All subjects treated with salmeterol/fluticasone propionate 50/250 µg b.i.d without any other intervention will be included in Period 1'}]}], 'composition_semantics': 'study_intervention_labels_not_product_formula', 'sponsors': [{'name': 'GlaxoSmithKline', 'role': 'lead', 'agency_class': 'INDUSTRY'}], 'facilities': [{'zip': 'DK-9100', 'city': 'Aalborg', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Denmark'}, {'zip': 'DK-8000', 'city': 'Aarhus C', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Denmark'}, {'zip': '2650', 'city': 'Hvidovre', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Denmark'}, {'zip': '2400', 'city': 'København NV', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Denmark'}, {'zip': '4700', 'city': 'Næstved', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Denmark'}, {'zip': '5000', 'city': 'Odense C', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Denmark'}, {'zip': '5000', 'city': 'Aarau', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '4123', 'city': 'Allschwil', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '4001', 'city': 'Basel', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '4031', 'city': 'Basel', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '4053', 'city': 'Basel', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '4054', 'city': 'Basel', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '4058', 'city': 'Basel', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '3007', 'city': 'Bern', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '3011', 'city': 'Bern', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '3012', 'city': 'Bern', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '7502', 'city': 'Bever', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '4805', 'city': 'Brittnau', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '6532', 'city': 'Castione', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '3186', 'city': 'Düdingen', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '8132', 'city': 'Egg', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '8639', 'city': 'Faltigberg-Wald', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '6048', 'city': 'Horw', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '7250', 'city': 'Klosters Platz', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '6713', 'city': 'Malvaglia', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '6900', 'city': 'Massagno', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '6963', 'city': 'Pregassona', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '8266', 'city': 'Steckborn', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '3600', 'city': 'Thun', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '8636', 'city': 'Wald', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '8556', 'city': 'Wigoltingen', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}, {'zip': '3076', 'city': 'Worb', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Switzerland'}], 'outcomes': [], 'brief_summary': 'This study will investigate whether study subjects with previously uncontrolled asthma treated with SERETIDE Diskus 50/250 CCI18781+GR33343 mcg twice a day can attain a level of Total Control of their condition and whether adherence to treatment can be enhanced by teaching the subjects. Two groups of equal size with identical medical treatment will be compared with each other, the test group receiving three training modules during study visits and the control group regular study visits only.', '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': '2005-07-26', 'start_date_precision': 'day', 'completion_date_type': 'ACTUAL', 'completion_month_year': '2007-06-13', 'completion_date_precision': 'day', 'primary_completion_date': '2007-06-13', 'primary_completion_month_year': '2007-06-13', 'primary_completion_date_precision': 'day', 'primary_completion_date_type': 'ACTUAL', 'intervention_component_groups': [['salmeterol', 'unmapped:250-g', 'unmapped:3-training-sessions-of-compliance-enhancement-training', 'unmapped:fluticasone-propionate-50'], ['salmeterol', 'unmapped:250-g', 'unmapped:fluticasone-propionate-50']], 'intervention_normalization': [{'name': 'salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training', 'selected_label': 'salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['salmeterol', 'unmapped:250-g', 'unmapped:3-training-sessions-of-compliance-enhancement-training', 'unmapped:fluticasone-propionate-50'], 'unverified_label_components': ['unmapped:250-g', 'unmapped:3-training-sessions-of-compliance-enhancement-training', 'unmapped:fluticasone-propionate-50'], 'items': [{'original': 'salmeterol', 'component': 'salmeterol', 'status': 'resolved', 'method': 'versioned_lexicon'}, {'original': 'fluticasone propionate 50', 'component': 'unmapped:fluticasone-propionate-50', 'status': 'unresolved', 'method': 'no_verified_mapping'}, {'original': '250 µg', 'component': 'unmapped:250-g', 'status': 'unresolved', 'method': 'no_verified_mapping'}, {'original': '3 training sessions of compliance enhancement training', 'component': 'unmapped:3-training-sessions-of-compliance-enhancement-training', 'status': 'unresolved', 'method': 'no_verified_mapping'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}, {'name': 'salmeterol/fluticasone propionate 50/250 µg', 'selected_label': 'salmeterol/fluticasone propionate 50/250 µg', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['salmeterol', 'unmapped:250-g', 'unmapped:fluticasone-propionate-50'], 'unverified_label_components': ['unmapped:250-g', 'unmapped:fluticasone-propionate-50'], 'items': [{'original': 'salmeterol', 'component': 'salmeterol', 'status': 'resolved', 'method': 'versioned_lexicon'}, {'original': 'fluticasone propionate 50', 'component': 'unmapped:fluticasone-propionate-50', 'status': 'unresolved', 'method': 'no_verified_mapping'}, {'original': '250 µg', 'component': 'unmapped:250-g', 'status': 'unresolved', 'method': 'no_verified_mapping'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}]}