Study to Assess the Incidence of Local Oropharyngeal and Laryngeal Adverse Effects of Advair DISKUS 250/50 mcg BID
Факт источника
Основные сведения
- Компания / организация
- Allergy & Asthma Medical Group & Research Center
- Протокол
- NONE0-L00081
- Фаза
- PHASE4
- Статус
- COMPLETED
- Дата начала
- 31.08.2005
- Дата завершения
- 30.11.2005
- Участники
- 13
- Результаты
- Не найдены
Нормализация
Исходный и нормализованный состав
Сопоставление
Связанные записи
История
Изменения относительно загрузок
details{'conditions': ['Asthma', 'Candidiasis, Oral', 'Voice Disorders'], 'countries': ['United States'], 'interventions': [{'name': 'fluticasone/salmeterol DISKUS 250/50', 'type': 'DRUG', 'description': None}], 'sponsors': [{'name': 'Allergy & Asthma Medical Group & Research Center', 'role': 'lead', 'agency_class': 'OTHER'}], 'facilities': [{'zip': '92123', 'city': 'San Diego', 'name': 'Allergy & Asthma Medical Group & Research Center', 'state': 'California', 'country': 'United States'}], 'outcomes': [], 'brief_summary': 'This Pilot study is designed to explore the rate of local side effects of fluticasone as delivered by Advair and to determine the best outcome measure to assess these effects. This study is the initial step, and will be followed by a larger scale study.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'Allergy & Asthma Medical Group & Research Center', 'results_first_posted_date': None, 'has_results_basis': 'results_first_posted_date'}→{'conditions': ['Asthma', 'Candidiasis, Oral', 'Voice Disorders'], 'countries': ['United States'], 'interventions': [{'name': 'fluticasone/salmeterol DISKUS 250/50', 'type': 'DRUG', 'description': None, 'other_names': [], 'design_groups': []}], 'composition_semantics': 'study_intervention_labels_not_product_formula', 'sponsors': [{'name': 'Allergy & Asthma Medical Group & Research Center', 'role': 'lead', 'agency_class': 'OTHER'}], 'facilities': [{'zip': '92123', 'city': 'San Diego', 'name': 'Allergy & Asthma Medical Group & Research Center', 'state': 'California', 'country': 'United States'}], 'outcomes': [], 'brief_summary': 'This Pilot study is designed to explore the rate of local side effects of fluticasone as delivered by Advair and to determine the best outcome measure to assess these effects. This study is the initial step, and will be followed by a larger scale study.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'Allergy & Asthma Medical Group & Research Center', 'results_first_posted_date': None, 'has_results_basis': 'results_first_posted_date', 'start_date_type': None, 'start_month_year': '2005-08', 'start_date_precision': 'month', 'completion_date_type': None, 'completion_month_year': '2005-11', 'completion_date_precision': 'month', 'primary_completion_date': None, 'primary_completion_month_year': None, 'primary_completion_date_precision': None, 'primary_completion_date_type': None, 'intervention_component_groups': [['fluticasone', 'unmapped:50', 'unmapped:salmeterol-diskus-250']], 'intervention_normalization': [{'name': 'fluticasone/salmeterol DISKUS 250/50', 'selected_label': 'fluticasone/salmeterol DISKUS 250/50', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['fluticasone', 'unmapped:50', 'unmapped:salmeterol-diskus-250'], 'unverified_label_components': ['unmapped:50', 'unmapped:salmeterol-diskus-250'], 'items': [{'original': 'fluticasone', 'component': 'fluticasone', 'status': 'resolved', 'method': 'versioned_lexicon'}, {'original': 'salmeterol DISKUS 250', 'component': 'unmapped:salmeterol-diskus-250', 'status': 'unresolved', 'method': 'no_verified_mapping'}, {'original': '50', 'component': 'unmapped:50', 'status': 'unresolved', 'method': 'no_verified_mapping'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}]}