Repeat Dose Study of Fluticasone Propionate/Salmeterol Versus Fluticasone Propionate + Salmeterol In Asthmatics
Факт источника
Основные сведения
- Компания / организация
- GlaxoSmithKline
- Протокол
- SAS10019
- Фаза
- PHASE1
- Статус
- COMPLETED
- Дата начала
- 28.01.2005
- Дата завершения
- 13.04.2005
- Участники
- 12
- Результаты
- Не найдены
Нормализация
Исходный и нормализованный состав
Сопоставление
Связанные записи
История
Изменения относительно загрузок
details{'conditions': ['Asthma'], 'countries': ['Germany'], 'interventions': [{'name': 'fluticasone propionate/salmeterol', 'type': 'DRUG', 'description': 'investigational drug'}], 'sponsors': [{'name': 'GlaxoSmithKline', 'role': 'lead', 'agency_class': 'INDUSTRY'}], 'facilities': [{'zip': '14050', 'city': 'Berlin', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Germany'}], 'outcomes': [], 'brief_summary': 'A new formulation of Fluticasone propionate/Salmeterol comparing a lower dose of fluticasone propionate and salmeterol was compared with concurrent administration of fluticasone propionate and salmeterol. Administration occurred over 14 days and tolerability, PK (pharmacokinetic) and PD (pharmacodynamic) measurements were performed.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'GlaxoSmithKline', 'results_first_posted_date': None, 'has_results_basis': 'results_first_posted_date'}→{'conditions': ['Asthma'], 'countries': ['Germany'], 'interventions': [{'name': 'fluticasone propionate/salmeterol', 'type': 'DRUG', 'description': 'investigational drug', 'other_names': [], 'design_groups': [{'id': 421214792, 'type': 'EXPERIMENTAL', 'title': 'Arm 1', 'description': 'investigational drug'}]}], 'composition_semantics': 'study_intervention_labels_not_product_formula', 'sponsors': [{'name': 'GlaxoSmithKline', 'role': 'lead', 'agency_class': 'INDUSTRY'}], 'facilities': [{'zip': '14050', 'city': 'Berlin', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Germany'}], 'outcomes': [], 'brief_summary': 'A new formulation of Fluticasone propionate/Salmeterol comparing a lower dose of fluticasone propionate and salmeterol was compared with concurrent administration of fluticasone propionate and salmeterol. Administration occurred over 14 days and tolerability, PK (pharmacokinetic) and PD (pharmacodynamic) measurements were performed.', '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': '2005-01-28', 'start_date_precision': 'day', 'completion_date_type': 'ACTUAL', 'completion_month_year': '2005-04-13', 'completion_date_precision': 'day', 'primary_completion_date': '2005-04-13', 'primary_completion_month_year': '2005-04-13', 'primary_completion_date_precision': 'day', 'primary_completion_date_type': 'ACTUAL', 'intervention_component_groups': [['fluticasone', 'salmeterol']], 'intervention_normalization': [{'name': 'fluticasone propionate/salmeterol', 'selected_label': 'fluticasone propionate/salmeterol', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['fluticasone', 'salmeterol'], 'unverified_label_components': [], 'items': [{'original': 'fluticasone propionate', 'component': 'fluticasone', 'status': 'resolved', 'method': 'versioned_lexicon'}, {'original': 'salmeterol', 'component': 'salmeterol', 'status': 'resolved', 'method': 'versioned_lexicon'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}]}