Сформировано 12.08.2026 · 13:15 CSV Экспорт XLSX
AACT · ClinicalTrials.gov Офлайн-снимок AACT · ClinicalTrials.gov NCT00296491 Международное исследование

Study Of Allergic Rhinitis In Patients Who Also Have Asthma

Нормализованный состав
fluticasone advair diskus fluticasone propionate fp montelukast mon salmeterol fsc +2
Информация Изменилось с прошлой загрузки Информация Связь с регистрацией не подтверждена

Факт источника

Основные сведения

Компания / организация
GlaxoSmithKline
Протокол
ADA103575
Фаза
PHASE4
Статус
COMPLETED
Дата начала
30.09.2005
Дата завершения
31.10.2007
Участники
725
Результаты
Опубликованы

Нормализация

Исходный и нормализованный состав

Факт источника fluticasone propionate + salmeterol (FSC) + montelukast (MON) + fluticasone propionate (FP) + placebo nasal + ADVAIR DISKUS + placebo capsule + placebo DISKUS Значение сохранено без подмены исходного факта.
Нормализованное значение
fluticasone advair diskus fluticasone propionate fp montelukast mon salmeterol fsc
Используется для поиска, сравнения и связывания.

Сопоставление

54

История

Изменения относительно загрузок

1

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'Canada'}, {'zip': 'G8T 7A1', 'city': 'Trois-Rivières', 'name': 'GSK Investigational Site', 'state': 'Quebec', 'country': 'Canada'}, {'zip': '13419', 'city': 'Tallinn', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Estonia'}, {'zip': '51014', 'city': 'Tartu', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Estonia'}, {'zip': '15-025', 'city': 'Bialystok', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Poland'}, {'zip': '15-274', 'city': 'Bialystok', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Poland'}, {'zip': '31-023', 'city': 'Krakow', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Poland'}, {'zip': '93-513', 'city': 'Lodz', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Poland'}], 'outcomes': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline at Endpoint in Morning Peak Expiration Flow (PEF) for Intent-to-Treat Population', 'time_frame': 'Baseline to Endpoint (weeks 3-4)', 'description': 'Endpoint was defined as the average of the data reported from the last week of treatment. Data collected by patient throughout the treatment period between visits. The peak expiratory flow rate measures how fast a person can breathe out (exhale) air. It is one of many tests that measure how well your airways work.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline at Endpoint in Morning Peak Expiratory Flow (PEF) for Per Protocol Population', 'time_frame': 'Baseline to Endpoint (weeks 3-4)', 'description': 'Endpoint was defined as the average of the data reported from the last week of treatment. Data collected by patient throughout the treatment period between visits. The peak expiratory flow rate measures how fast a person can breathe out (exhale) air. It is one of many tests that measure how well your airways work.'}, {'type': 'SECONDARY', 'title': 'Rhinitis: Mean Change From Baseline at 1-2 Weeks in Daytime Total Nasal Symptom Scores (D-TNNS).', 'time_frame': 'Baseline to 1-2 Weeks', 'description': 'The sum of scores of each of the four daytime symptoms (nasal congestion, itching, rhinorrhea, and sneezing). Scale: 0=none (no sign/symptom evident)1=mild (sign/symptom clearly present; easily tolerated)2=moderate (definite awareness of sign/symptom that is bothersome but tolerable)3=severe (sign/symptom is hard to tolerate)'}, {'type': 'SECONDARY', 'title': 'Rhinitis: Mean Change From Baseline at 1-2 Weeks in Nightime Total Nasal Symptom Scores (N-TNSS)', 'time_frame': 'Baseline To 1-2 Weeks', 'description': 'The scores of 3 nighttime symptoms (nasal congestion upon awakening, difficulty going to sleep due to nasal symptoms, nighttime awakenings due to nasal symptoms). Scale: 0=not noticeable, 1=noticeable but not bothersome, 2=noticeable and bothersome some of the time, 3=bothersome most of the time and/or very bothersome some of the time.'}, {'type': 'SECONDARY', 'title': 'Asthma: Mean Change From Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Intent-to-Treat Population', 'time_frame': 'Baseline to Endpoint (weeks 3-4)', 'description': "Endpoint was defined as the average of the last week's worth of evaluable data. The volume of air that can be forced out taking a deep breath, an important measure of pulmonary function. FEV1 is forced expiratory volume in one second."}, {'type': 'SECONDARY', 'title': 'Asthma: Mean Change From Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Per Protocol Population', 'time_frame': 'Baseline to Endpoint (weeks 3-4)', 'description': "Endpoint was defined as the average of the last week's worth of evaluable data. The volume of air that can be forced out taking a deep breath, an important measure of pulmonary function. FEV1 is forced expiratory volume in one second."}, {'type': 'SECONDARY', 'title': 'Asthma: Mean Change From Baseline at Endpoint in Percentage of Asthma Symptom-Free Days for Intent-to-Treat Population', 'time_frame': 'Baseline to Endpoint (weeks 3-4)', 'description': 'Endpoint was defined as the average of the data reported from the last week of treatment.Asthma symptom scores and the subject-rated overall satisfaction with treatment, related to the percentage of asthma symptom-free days. Same scale used as in outcome 8.'}, {'type': 'SECONDARY', 'title': 'Asthma: Mean Change From Baseline at Endpoint in Percentage of Asthma Symptom-Free Days for Per Protocol Population', 'time_frame': 'Baseline to Endpoint (weeks 3-4)', 'description': 'Asthma symptom score:0=no symptoms,1=symptoms 1 short period,2=symptoms 2 or more short periods,3=symptoms most of day not affect activities,4=symptoms most of day did affect activities,5=symptoms severe.Overall satisfaction score:0=very dissatisfied,1=dissatisfied,2=slightly dissatisfied,3=neutral,4=slightly satisfied,5=satisfied 6=very satisfied'}, {'type': 'SECONDARY', 'title': 'Asthma: Mean Change From Baseline at Endpoint in Percentage of Albuterol-Salbutamol Free Days for Intent-to-Treat Population', 'time_frame': 'Baseline to Endpoint (weeks 3-4)', 'description': 'Endpoint was defined as the average of the data reported from the last week of treatment. Albuterol/salbutamol use (related to percentage of asthma rescue-free days).'}, {'type': 'SECONDARY', 'title': 'Asthma: Mean Change From Baseline at Endpoint in Percentage of Albuterol/Salbutamol-Free Days for Per Protocol Population', 'time_frame': 'Baseline to Endpoint (weeks 3-4)', 'description': 'Endpoint was defined as the average of the data reported from the last week of treatment. Albuterol/salbutamol use (related to percentage of asthma rescue-free days).'}], 'brief_summary': 'This study will last up to 6 weeks. Subjects will visit the clinic up to 5 times. Certain clinic visits will include a physical examination, medical history review, and lung function tests. All study related medications and medical examinations will be provided at no cost to the subject. The drugs used in this study are approved for the age group under study.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'GlaxoSmithKline', 'results_first_posted_date': '2009-05-13', 'has_results_basis': 'results_first_posted_date'}{'conditions': ['Asthma'], 'countries': ['Canada', 'Estonia', 'Poland', 'United States'], 'interventions': [{'name': 'fluticasone propionate/salmeterol (FSC)', 'type': 'DRUG', 'description': 'fluticasone propionate/salmeterol DISKUS combination', 'other_names': [], 'design_groups': [{'id': 421736808, 'type': 'ACTIVE_COMPARATOR', 'title': 'Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)', 'description': 'Fluticasone propionate/salmeterol DISKUS combination product (FSC) twice daily (BID) plus vehicle placebo nasal spray once daily (QD) plus montelukast capsule 10mg (MON) QD'}, {'id': 421736809, 'type': 'ACTIVE_COMPARATOR', 'title': 'Fluticasone Propionate/Salmeterol (FSC)', 'description': 'FSC BID plus vehicle placebo nasal spray QD plus placebo capsule QD'}, {'id': 421736810, 'type': 'ACTIVE_COMPARATOR', 'title': 'Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS)', 'description': 'Fluticasone propionate/salmeterol DISKUS combination product (FSC)100/50mcg BID plus fluticasone propionate aqueous nasal spray 200mcg (FPANS) QD plus placebo capsule QD'}]}, {'name': 'montelukast (MON)', 'type': 'DRUG', 'description': 'montelukast capsule', 'other_names': [], 'design_groups': [{'id': 421736808, 'type': 'ACTIVE_COMPARATOR', 'title': 'Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)', 'description': 'Fluticasone propionate/salmeterol DISKUS combination product (FSC) twice daily (BID) plus vehicle placebo nasal spray once daily (QD) plus montelukast capsule 10mg (MON) QD'}, {'id': 421736811, 'type': 'ACTIVE_COMPARATOR', 'title': 'Montelukast (MON)', 'description': 'Placebo DISKUS BID plus vehicle placebo nasal spray QD plus MON QD'}]}, {'name': 'fluticasone propionate (FP)', 'type': 'DRUG', 'description': 'fluticasone propionate aqueous nasal spray', 'other_names': [], 'design_groups': [{'id': 421736810, 'type': 'ACTIVE_COMPARATOR', 'title': 'Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS)', 'description': 'Fluticasone propionate/salmeterol DISKUS combination product (FSC)100/50mcg BID plus fluticasone propionate aqueous nasal spray 200mcg (FPANS) QD plus placebo capsule QD'}]}, {'name': 'placebo nasal', 'type': 'DRUG', 'description': 'vehicle placebo nasal spray', 'other_names': [], 'design_groups': [{'id': 421736808, 'type': 'ACTIVE_COMPARATOR', 'title': 'Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)', 'description': 'Fluticasone propionate/salmeterol DISKUS combination product (FSC) twice daily (BID) plus vehicle placebo nasal spray once daily (QD) plus montelukast capsule 10mg (MON) QD'}, {'id': 421736809, 'type': 'ACTIVE_COMPARATOR', 'title': 'Fluticasone Propionate/Salmeterol (FSC)', 'description': 'FSC BID plus vehicle placebo nasal spray QD plus placebo capsule QD'}, {'id': 421736811, 'type': 'ACTIVE_COMPARATOR', 'title': 'Montelukast (MON)', 'description': 'Placebo DISKUS BID plus vehicle placebo nasal spray QD plus MON QD'}]}, {'name': 'ADVAIR DISKUS', 'type': 'DRUG', 'description': 'ADVAIR DISKUS', 'other_names': [], 'design_groups': [{'id': 421736808, 'type': 'ACTIVE_COMPARATOR', 'title': 'Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)', 'description': 'Fluticasone propionate/salmeterol DISKUS combination product (FSC) twice daily (BID) plus vehicle placebo nasal spray once daily (QD) plus montelukast capsule 10mg (MON) QD'}, {'id': 421736809, 'type': 'ACTIVE_COMPARATOR', 'title': 'Fluticasone Propionate/Salmeterol (FSC)', 'description': 'FSC BID plus vehicle placebo nasal spray QD plus placebo capsule QD'}, {'id': 421736810, 'type': 'ACTIVE_COMPARATOR', 'title': 'Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS)', 'description': 'Fluticasone propionate/salmeterol DISKUS combination product (FSC)100/50mcg BID 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'name': 'GSK Investigational Site', 'state': 'Ontario', 'country': 'Canada'}, {'zip': 'K2C 3R2', 'city': 'Ottawa', 'name': 'GSK Investigational Site', 'state': 'Ontario', 'country': 'Canada'}, {'zip': 'G1V 4M6', 'city': 'Québec', 'name': 'GSK Investigational Site', 'state': 'Quebec', 'country': 'Canada'}, {'zip': 'G8T 7A1', 'city': 'Trois-Rivières', 'name': 'GSK Investigational Site', 'state': 'Quebec', 'country': 'Canada'}, {'zip': '13419', 'city': 'Tallinn', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Estonia'}, {'zip': '51014', 'city': 'Tartu', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Estonia'}, {'zip': '15-025', 'city': 'Bialystok', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Poland'}, {'zip': '15-274', 'city': 'Bialystok', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Poland'}, {'zip': '31-023', 'city': 'Krakow', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Poland'}, {'zip': '93-513', 'city': 'Lodz', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Poland'}], 'outcomes': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline at Endpoint in Morning Peak Expiration Flow (PEF) for Intent-to-Treat Population', 'time_frame': 'Baseline to Endpoint (weeks 3-4)', 'description': 'Endpoint was defined as the average of the data reported from the last week of treatment. Data collected by patient throughout the treatment period between visits. The peak expiratory flow rate measures how fast a person can breathe out (exhale) air. It is one of many tests that measure how well your airways work.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline at Endpoint in Morning Peak Expiratory Flow (PEF) for Per Protocol Population', 'time_frame': 'Baseline to Endpoint (weeks 3-4)', 'description': 'Endpoint was defined as the average of the data reported from the last week of treatment. Data collected by patient throughout the treatment period between visits. The peak expiratory flow rate measures how fast a person can breathe out (exhale) air. It is one of many tests that measure how well your airways work.'}, {'type': 'SECONDARY', 'title': 'Rhinitis: Mean Change From Baseline at 1-2 Weeks in Daytime Total Nasal Symptom Scores (D-TNNS).', 'time_frame': 'Baseline to 1-2 Weeks', 'description': 'The sum of scores of each of the four daytime symptoms (nasal congestion, itching, rhinorrhea, and sneezing). Scale: 0=none (no sign/symptom evident)1=mild (sign/symptom clearly present; easily tolerated)2=moderate (definite awareness of sign/symptom that is bothersome but tolerable)3=severe (sign/symptom is hard to tolerate)'}, {'type': 'SECONDARY', 'title': 'Rhinitis: Mean Change From Baseline at 1-2 Weeks in Nightime Total Nasal Symptom Scores (N-TNSS)', 'time_frame': 'Baseline To 1-2 Weeks', 'description': 'The scores of 3 nighttime symptoms (nasal congestion upon awakening, difficulty going to sleep due to nasal symptoms, nighttime awakenings due to nasal symptoms). Scale: 0=not noticeable, 1=noticeable but not bothersome, 2=noticeable and bothersome some of the time, 3=bothersome most of the time and/or very bothersome some of the time.'}, {'type': 'SECONDARY', 'title': 'Asthma: Mean Change From Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Intent-to-Treat Population', 'time_frame': 'Baseline to Endpoint (weeks 3-4)', 'description': "Endpoint was defined as the average of the last week's worth of evaluable data. The volume of air that can be forced out taking a deep breath, an important measure of pulmonary function. FEV1 is forced expiratory volume in one second."}, {'type': 'SECONDARY', 'title': 'Asthma: Mean Change From Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Per Protocol Population', 'time_frame': 'Baseline to Endpoint (weeks 3-4)', 'description': "Endpoint was defined as the average of the last week's worth of evaluable data. The volume of air that can be forced out taking a deep breath, an important measure of pulmonary function. FEV1 is forced expiratory volume in one second."}, {'type': 'SECONDARY', 'title': 'Asthma: Mean Change From Baseline at Endpoint in Percentage of Asthma Symptom-Free Days for Intent-to-Treat Population', 'time_frame': 'Baseline to Endpoint (weeks 3-4)', 'description': 'Endpoint was defined as the average of the data reported from the last week of treatment.Asthma symptom scores and the subject-rated overall satisfaction with treatment, related to the percentage of asthma symptom-free days. Same scale used as in outcome 8.'}, {'type': 'SECONDARY', 'title': 'Asthma: Mean Change From Baseline at Endpoint in Percentage of Asthma Symptom-Free Days for Per Protocol Population', 'time_frame': 'Baseline to Endpoint (weeks 3-4)', 'description': 'Asthma symptom score:0=no symptoms,1=symptoms 1 short period,2=symptoms 2 or more short periods,3=symptoms most of day not affect activities,4=symptoms most of day did affect activities,5=symptoms severe.Overall satisfaction score:0=very dissatisfied,1=dissatisfied,2=slightly dissatisfied,3=neutral,4=slightly satisfied,5=satisfied 6=very satisfied'}, {'type': 'SECONDARY', 'title': 'Asthma: Mean Change From Baseline at Endpoint in Percentage of Albuterol-Salbutamol Free Days for Intent-to-Treat Population', 'time_frame': 'Baseline to Endpoint (weeks 3-4)', 'description': 'Endpoint was defined as the average of the data reported from the last week of treatment. Albuterol/salbutamol use (related to percentage of asthma rescue-free days).'}, {'type': 'SECONDARY', 'title': 'Asthma: Mean Change From Baseline at Endpoint in Percentage of Albuterol/Salbutamol-Free Days for Per Protocol Population', 'time_frame': 'Baseline to Endpoint (weeks 3-4)', 'description': 'Endpoint was defined as the average of the data reported from the last week of treatment. Albuterol/salbutamol use (related to percentage of asthma rescue-free days).'}], 'brief_summary': 'This study will last up to 6 weeks. Subjects will visit the clinic up to 5 times. Certain clinic visits will include a physical examination, medical history review, and lung function tests. All study related medications and medical examinations will be provided at no cost to the subject. The drugs used in this study are approved for the age group under study.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'GlaxoSmithKline', 'results_first_posted_date': '2009-05-13', 'has_results_basis': 'results_first_posted_date', 'start_date_type': None, 'start_month_year': '2005-09', 'start_date_precision': 'month', 'completion_date_type': 'ACTUAL', 'completion_month_year': '2007-10', 'completion_date_precision': 'month', 'primary_completion_date': '2007-10-31', 'primary_completion_month_year': '2007-10', 'primary_completion_date_precision': 'month', 'primary_completion_date_type': 'ACTUAL', 'intervention_component_groups': [['fluticasone', 'unmapped:salmeterol-fsc'], ['unmapped:montelukast-mon'], ['unmapped:fluticasone-propionate-fp'], ['unmapped:advair-diskus']], 'intervention_normalization': [{'name': 'fluticasone propionate/salmeterol (FSC)', 'selected_label': 'fluticasone propionate/salmeterol (FSC)', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['fluticasone', 'unmapped:salmeterol-fsc'], 'unverified_label_components': ['unmapped:salmeterol-fsc'], 'items': [{'original': 'fluticasone propionate', 'component': 'fluticasone', 'status': 'resolved', 'method': 'versioned_lexicon'}, {'original': 'salmeterol (FSC)', 'component': 'unmapped:salmeterol-fsc', 'status': 'unresolved', 'method': 'no_verified_mapping'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}, {'name': 'montelukast (MON)', 'selected_label': 'montelukast (MON)', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['unmapped:montelukast-mon'], 'unverified_label_components': ['unmapped:montelukast-mon'], 'items': [{'original': 'montelukast (MON)', 'component': 'unmapped:montelukast-mon', 'status': 'unresolved', 'method': 'no_verified_mapping'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}, {'name': 'fluticasone propionate (FP)', 'selected_label': 'fluticasone propionate (FP)', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['unmapped:fluticasone-propionate-fp'], 'unverified_label_components': ['unmapped:fluticasone-propionate-fp'], 'items': [{'original': 'fluticasone propionate (FP)', 'component': 'unmapped:fluticasone-propionate-fp', 'status': 'unresolved', 'method': 'no_verified_mapping'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}, {'name': 'placebo nasal', 'role': 'accessory', 'components': [], 'excluded_accessory_parts': ['placebo nasal']}, {'name': 'ADVAIR DISKUS', 'selected_label': 'ADVAIR DISKUS', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['unmapped:advair-diskus'], 'unverified_label_components': ['unmapped:advair-diskus'], 'items': [{'original': 'ADVAIR DISKUS', 'component': 'unmapped:advair-diskus', 'status': 'unresolved', 'method': 'no_verified_mapping'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}, {'name': 'placebo capsule', 'role': 'accessory', 'components': [], 'excluded_accessory_parts': ['placebo capsule']}, {'name': 'placebo DISKUS', 'role': 'accessory', 'components': [], 'excluded_accessory_parts': ['placebo DISKUS']}]}

normalized_displayФлутиказон + unmapped:advair-diskus + unmapped:fluticasone-propionate-fp + unmapped:montelukast-mon + unmapped:placebo-capsule + unmapped:placebo-diskus + unmapped:placebo-nasal + unmapped:salmeterol-fscФлутиказон + unmapped:advair-diskus + unmapped:fluticasone-propionate-fp + unmapped:montelukast-mon + unmapped:salmeterol-fsc