Childhood Asthma Research and Education (CARE) Network Trial - Best Add-On Therapy Giving Effective Response (BADGER)
Нормализованный состав
fluticasone
montelukast
salmeterol
Завершено
Первоисточник ↗
Информация
Изменилось с прошлой загрузки
Информация
Связь с регистрацией не подтверждена
Факт источника
Основные сведения
- Компания / организация
- Milton S. Hershey Medical Center
- Протокол
- 444
- Фаза
- PHASE3
- Статус
- Завершено
- Дата начала
- 31.03.2007
- Дата завершения
- 31.12.2011
- Участники
- 182
- Результаты
- Опубликованы
Нормализация
Исходный и нормализованный состав
Факт источника
fluticasone propionate + montelukast + fluticasone propionate + fluticasone propionate + salmeterol
Значение сохранено без подмены исходного факта.
Нормализованное значение
fluticasone
montelukast
salmeterol
Используется для поиска, сравнения и связывания.
Сопоставление
Связанные записи
История
Изменения относительно загрузок
details{'conditions': ['Asthma'], 'countries': ['United States'], 'interventions': [{'name': 'fluticasone propionate + montelukast', 'type': 'DRUG', 'description': 'Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)'}, {'name': 'fluticasone propionate', 'type': 'DRUG', 'description': 'Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)'}, {'name': 'fluticasone propionate + salmeterol', 'type': 'DRUG', 'description': 'Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)'}], 'sponsors': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'role': 'collaborator', 'agency_class': 'NIH'}, {'name': 'Milton S. Hershey Medical Center', 'role': 'lead', 'agency_class': 'OTHER'}], 'facilities': [{'zip': '85724', 'city': 'Tucson', 'name': 'University of Arizona College of Medicine', 'state': 'Arizona', 'country': 'United States'}, {'zip': '92111', 'city': 'San Diego', 'name': 'Kaiser Permanente Medical Center', 'state': 'California', 'country': 'United States'}, {'zip': '80206', 'city': 'Denver', 'name': 'National Jewish Medical and Research Center', 'state': 'Colorado', 'country': 'United States'}, {'zip': '63110', 'city': 'St Louis', 'name': 'Washington University School of Medicine', 'state': 'Missouri', 'country': 'United States'}, {'zip': '53792', 'city': 'Madison', 'name': 'University of Wisconsin - Madison', 'state': 'Wisconsin', 'country': 'United States'}], 'outcomes': [{'type': 'PRIMARY', 'title': 'The Number of Participants With a Differential Response to the Three Step-up Therapies Based on Fixed Threshold Criteria for the Following Three Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations, Asthma Control Days and FEV1.', 'time_frame': 'Measured during the last 12 weeks of each 16-week treatment period', 'description': 'One treatment period was ranked as better than another if the total amount of prednisone received during the period was at least 180 mg less, if the number of annualized asthma-control days during the final 12 weeks of the period was increased by at least 31 days, or if the FEV1 at the end of the period was at least 5% higher. If the prednisone threshold was met, then we ignored the number of asthmacontrol days and the FEV1. If the threshold for asthma-control days was met, then we ignored the FEV1. Otherwise, the order of response was determined by the FEV1.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) % Predicted', 'time_frame': 'Measured during the last 12 weeks of each 16-week treatment period', 'description': None}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Post-bronchodilator FEV1 Percent Predicted', 'time_frame': 'Measured during the last 12 weeks of each 16-week treatment period', 'description': None}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Pre-bronchodilator Forced Vital Capacity (FVC) % Predicted', 'time_frame': 'Measured during the last 12 weeks of each 16-week treatment period', 'description': None}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Pre-bronchodilator FEV1/FVC Ratio', 'time_frame': 'Measured during the last 12 weeks of each 16-week treatment period', 'description': None}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Morning Peak Expiratory Flow Rate (PEFR) % Predicted', 'time_frame': 'Measured during the last 12 weeks of each 16-week treatment period', 'description': None}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Evening Peak Expiratory Flow Rate (PEFR) % Predicted', 'time_frame': 'Measured during the last 12 weeks of each 16-week treatment period', 'description': None}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Peak Expiratory Flow Rate (PEFR) Variability', 'time_frame': 'Measured during the last 12 weeks of each 16-week treatment period', 'description': 'PEFR variability is calculated as 100% times the difference between the evening and morning PEFR values, divided by the average of the evening and morning PEFR values, i.e., PEFR variability = 100% x (morning PEFR - evening PEFR)/((morning PEFR + evening PEFR)/2)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Impulse Oscillometry Resistance at 5 Hertz', 'time_frame': 'Measured during the last 12 weeks of each 16-week treatment period', 'description': 'Change from baseline in the impulse oscillometry resistance at 5 Hertz, measured in kiloPascals per liters per second'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Logarithm Base 2 of the Methacholine PC20', 'time_frame': 'Measured during the last 12 weeks of each 16-week treatment period', 'description': 'The methacholine PC20 is the concentration of methacholine that causes a 20% decrease in the pre-bronchodilator FEV1. The logarithm base 2 transformation converts the PC20 into doubling dilutions.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Natural Logarithm of Exhaled Nitric Oxide (eNO)', 'time_frame': 'Measured during the last 12 weeks of each 16-week treatment period', 'description': None}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Asthma Control Test (ACT)', 'time_frame': 'Measured during the last 12 weeks of each 16-week treatment period', 'description': 'The ACT consists of five items, each scored as 1 (worst) to 5 (best). The five items are averaged.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Asthma Quality of Life', 'time_frame': 'Measured during the last 12 weeks of each 16-week treatment period', 'description': 'Asthma quality of life is measured as the average of 23 questions, each of which is scored from 1 (worse) to 7 (best)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Asthma Exacerbations', 'time_frame': 'Measured during the last 12 weeks of each 16-week treatment period', 'description': 'An asthma exacerbation was defined as the administration of a course of oral/systemic prednisone for the treatment of asthma.'}], 'brief_summary': 'Asthma is a common, serious illness among children in the United States. While a low dose of inhaled corticosteroids (ICS) may effectively control symptoms, some children may require additional medications to maintain adequate asthma control. This study compares the effectiveness of a higher dose of ICS, ICS combined with a long-acting beta-agonist (LABA) medication, and ICS combined with a leukotriene receptor antagonist (LTRA) medication at reducing the impact and severity of asthma exacerbations that occur in children with mild to moderate persistent asthma.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'Milton S. Hershey Medical Center', 'results_first_posted_date': '2010-09-17', 'has_results_basis': 'results_first_posted_date'}→{'conditions': ['Asthma'], 'countries': ['United States'], 'interventions': [{'name': 'fluticasone propionate + montelukast', 'type': 'DRUG', 'description': 'Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)', 'other_names': ['Flovent Diskus® + Singulair®'], 'design_groups': [{'id': 421057839, 'type': 'EXPERIMENTAL', 'title': 'Sequence #1', 'description': 'fluticasone propionate + montelukast, followed by fluticasone propionate, followed by fluticasone propionate + salmeterol'}, {'id': 421057840, 'type': 'EXPERIMENTAL', 'title': 'Sequence #2', 'description': 'fluticasone propionate + montelukast, followed by fluticasone propionate + salmeterol, followed by followed by fluticasone propionate'}, {'id': 421057841, 'type': 'EXPERIMENTAL', 'title': 'Sequence #3', 'description': 'fluticasone propionate + salmeterol, followed by fluticasone propionate, followed by fluticasone propionate + montelukast'}, {'id': 421057842, 'type': 'EXPERIMENTAL', 'title': 'Sequence #4', 'description': 'fluticasone propionate + salmeterol, followed by fluticasone propionate + montelukast, followed by fluticasone propionate'}, {'id': 421057843, 'type': 'EXPERIMENTAL', 'title': 'Sequence #5', 'description': 'fluticasone propionate, followed by fluticasone propionate + salmeterol, followed by fluticasone propionate + montelukast'}, {'id': 421057844, 'type': 'EXPERIMENTAL', 'title': 'Sequence #6', 'description': 'fluticasone propionate, followed by fluticasone propionate + montelukast, followed by fluticasone propionate + salmeterol'}]}, {'name': 'fluticasone propionate', 'type': 'DRUG', 'description': 'Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)', 'other_names': ['Flovent Diskus®'], 'design_groups': [{'id': 421057839, 'type': 'EXPERIMENTAL', 'title': 'Sequence #1', 'description': 'fluticasone propionate + montelukast, followed by fluticasone propionate, followed by fluticasone propionate + salmeterol'}, {'id': 421057840, 'type': 'EXPERIMENTAL', 'title': 'Sequence #2', 'description': 'fluticasone propionate + montelukast, followed by fluticasone propionate + salmeterol, followed by followed by fluticasone propionate'}, {'id': 421057841, 'type': 'EXPERIMENTAL', 'title': 'Sequence #3', 'description': 'fluticasone propionate + salmeterol, followed by fluticasone propionate, followed by fluticasone propionate + montelukast'}, {'id': 421057842, 'type': 'EXPERIMENTAL', 'title': 'Sequence #4', 'description': 'fluticasone propionate + salmeterol, followed by fluticasone propionate + montelukast, followed by fluticasone propionate'}, {'id': 421057843, 'type': 'EXPERIMENTAL', 'title': 'Sequence #5', 'description': 'fluticasone propionate, followed by fluticasone propionate + salmeterol, followed by fluticasone propionate + montelukast'}, {'id': 421057844, 'type': 'EXPERIMENTAL', 'title': 'Sequence #6', 'description': 'fluticasone propionate, followed by fluticasone propionate + montelukast, followed by fluticasone propionate + salmeterol'}]}, {'name': 'fluticasone propionate + salmeterol', 'type': 'DRUG', 'description': 'Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)', 'other_names': ['Advair Diskus®'], 'design_groups': [{'id': 421057839, 'type': 'EXPERIMENTAL', 'title': 'Sequence #1', 'description': 'fluticasone propionate + montelukast, followed by fluticasone propionate, followed by fluticasone propionate + salmeterol'}, {'id': 421057840, 'type': 'EXPERIMENTAL', 'title': 'Sequence #2', 'description': 'fluticasone propionate + montelukast, followed by fluticasone propionate + salmeterol, followed by followed by fluticasone propionate'}, {'id': 421057841, 'type': 'EXPERIMENTAL', 'title': 'Sequence #3', 'description': 'fluticasone propionate + salmeterol, followed by fluticasone propionate, followed by fluticasone propionate + montelukast'}, {'id': 421057842, 'type': 'EXPERIMENTAL', 'title': 'Sequence #4', 'description': 'fluticasone propionate + salmeterol, followed by fluticasone propionate + montelukast, followed by fluticasone propionate'}, {'id': 421057843, 'type': 'EXPERIMENTAL', 'title': 'Sequence #5', 'description': 'fluticasone propionate, followed by fluticasone propionate + salmeterol, followed by fluticasone propionate + montelukast'}, {'id': 421057844, 'type': 'EXPERIMENTAL', 'title': 'Sequence #6', 'description': 'fluticasone propionate, followed by fluticasone propionate + montelukast, followed by fluticasone propionate + salmeterol'}]}], 'composition_semantics': 'study_intervention_labels_not_product_formula', 'sponsors': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'role': 'collaborator', 'agency_class': 'NIH'}, {'name': 'Milton S. Hershey Medical Center', 'role': 'lead', 'agency_class': 'OTHER'}], 'facilities': [{'zip': '85724', 'city': 'Tucson', 'name': 'University of Arizona College of Medicine', 'state': 'Arizona', 'country': 'United States'}, {'zip': '92111', 'city': 'San Diego', 'name': 'Kaiser Permanente Medical Center', 'state': 'California', 'country': 'United States'}, {'zip': '80206', 'city': 'Denver', 'name': 'National Jewish Medical and Research Center', 'state': 'Colorado', 'country': 'United States'}, {'zip': '63110', 'city': 'St Louis', 'name': 'Washington University School of Medicine', 'state': 'Missouri', 'country': 'United States'}, {'zip': '53792', 'city': 'Madison', 'name': 'University of Wisconsin - Madison', 'state': 'Wisconsin', 'country': 'United States'}], 'outcomes': [{'type': 'PRIMARY', 'title': 'The Number of Participants With a Differential Response to the Three Step-up Therapies Based on Fixed Threshold Criteria for the Following Three Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations, Asthma Control Days and FEV1.', 'time_frame': 'Measured during the last 12 weeks of each 16-week treatment period', 'description': 'One treatment period was ranked as better than another if the total amount of prednisone received during the period was at least 180 mg less, if the number of annualized asthma-control days during the final 12 weeks of the period was increased by at least 31 days, or if the FEV1 at the end of the period was at least 5% higher. If the prednisone threshold was met, then we ignored the number of asthmacontrol days and the FEV1. If the threshold for asthma-control days was met, then we ignored the FEV1. Otherwise, the order of response was determined by the FEV1.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) % Predicted', 'time_frame': 'Measured during the last 12 weeks of each 16-week treatment period', 'description': None}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Post-bronchodilator FEV1 Percent Predicted', 'time_frame': 'Measured during the last 12 weeks of each 16-week treatment period', 'description': None}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Pre-bronchodilator Forced Vital Capacity (FVC) % Predicted', 'time_frame': 'Measured during the last 12 weeks of each 16-week treatment period', 'description': None}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Pre-bronchodilator FEV1/FVC Ratio', 'time_frame': 'Measured during the last 12 weeks of each 16-week treatment period', 'description': None}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Morning Peak Expiratory Flow Rate (PEFR) % Predicted', 'time_frame': 'Measured during the last 12 weeks of each 16-week treatment period', 'description': None}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Evening Peak Expiratory Flow Rate (PEFR) % Predicted', 'time_frame': 'Measured during the last 12 weeks of each 16-week treatment period', 'description': None}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Peak Expiratory Flow Rate (PEFR) Variability', 'time_frame': 'Measured during the last 12 weeks of each 16-week treatment period', 'description': 'PEFR variability is calculated as 100% times the difference between the evening and morning PEFR values, divided by the average of the evening and morning PEFR values, i.e., PEFR variability = 100% x (morning PEFR - evening PEFR)/((morning PEFR + evening PEFR)/2)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Impulse Oscillometry Resistance at 5 Hertz', 'time_frame': 'Measured during the last 12 weeks of each 16-week treatment period', 'description': 'Change from baseline in the impulse oscillometry resistance at 5 Hertz, measured in kiloPascals per liters per second'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Logarithm Base 2 of the Methacholine PC20', 'time_frame': 'Measured during the last 12 weeks of each 16-week treatment period', 'description': 'The methacholine PC20 is the concentration of methacholine that causes a 20% decrease in the pre-bronchodilator FEV1. The logarithm base 2 transformation converts the PC20 into doubling dilutions.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Natural Logarithm of Exhaled Nitric Oxide (eNO)', 'time_frame': 'Measured during the last 12 weeks of each 16-week treatment period', 'description': None}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Asthma Control Test (ACT)', 'time_frame': 'Measured during the last 12 weeks of each 16-week treatment period', 'description': 'The ACT consists of five items, each scored as 1 (worst) to 5 (best). The five items are averaged.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Asthma Quality of Life', 'time_frame': 'Measured during the last 12 weeks of each 16-week treatment period', 'description': 'Asthma quality of life is measured as the average of 23 questions, each of which is scored from 1 (worse) to 7 (best)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Asthma Exacerbations', 'time_frame': 'Measured during the last 12 weeks of each 16-week treatment period', 'description': 'An asthma exacerbation was defined as the administration of a course of oral/systemic prednisone for the treatment of asthma.'}], 'brief_summary': 'Asthma is a common, serious illness among children in the United States. While a low dose of inhaled corticosteroids (ICS) may effectively control symptoms, some children may require additional medications to maintain adequate asthma control. This study compares the effectiveness of a higher dose of ICS, ICS combined with a long-acting beta-agonist (LABA) medication, and ICS combined with a leukotriene receptor antagonist (LTRA) medication at reducing the impact and severity of asthma exacerbations that occur in children with mild to moderate persistent asthma.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'Milton S. Hershey Medical Center', 'results_first_posted_date': '2010-09-17', 'has_results_basis': 'results_first_posted_date', 'start_date_type': None, 'start_month_year': '2007-03', 'start_date_precision': 'month', 'completion_date_type': 'ACTUAL', 'completion_month_year': '2011-12', 'completion_date_precision': 'month', 'primary_completion_date': '2011-12-31', 'primary_completion_month_year': '2011-12', 'primary_completion_date_precision': 'month', 'primary_completion_date_type': 'ACTUAL', 'intervention_component_groups': [['fluticasone', 'unmapped:montelukast'], ['fluticasone'], ['fluticasone', 'salmeterol']], 'intervention_normalization': [{'name': 'fluticasone propionate + montelukast', 'selected_label': 'fluticasone propionate + montelukast', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['fluticasone', 'unmapped:montelukast'], 'unverified_label_components': ['unmapped:montelukast'], 'items': [{'original': 'fluticasone propionate', 'component': 'fluticasone', 'status': 'resolved', 'method': 'versioned_lexicon'}, {'original': 'montelukast', 'component': 'unmapped:montelukast', 'status': 'unresolved', 'method': 'no_verified_mapping'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}, {'name': 'fluticasone propionate', 'selected_label': 'fluticasone propionate', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['fluticasone'], 'unverified_label_components': [], 'items': [{'original': 'fluticasone propionate', 'component': 'fluticasone', 'status': 'resolved', 'method': 'versioned_lexicon'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}, {'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': []}]}