Clinical Assessment Of GW815SF HFA MDI In Pediatric Patients With Bronchial Asthma

details{'conditions': ['Bronchial Asthma'], 'countries': ['Japan'], 'interventions': [{'name': 'GW815SF HFA MDI', 'type': 'DRUG', 'description': 'salmeterol and fluticasone propionate combination'}, {'name': 'salmeterol and fluticasone propionate', 'type': 'DRUG', 'description': 'salmeterol + fluticasone propionate'}], 'sponsors': [{'name': 'GlaxoSmithKline', 'role': 'lead', 'agency_class': 'INDUSTRY'}], 'facilities': [{'zip': '260-0001', 'city': 'Chiba', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Japan'}, {'zip': '245-0018', 'city': 'Kanagawa', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Japan'}, {'zip': '360-0018', 'city': 'Saitama', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Japan'}, {'zip': '360-0812', 'city': 'Saitama', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Japan'}, {'zip': '154-0002', 'city': 'Tokyo', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Japan'}, {'zip': '154-0017', 'city': 'Tokyo', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Japan'}, {'zip': '158-0083', 'city': 'Tokyo', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Japan'}, {'zip': '158-0097', 'city': 'Tokyo', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Japan'}], 'outcomes': [{'type': 'PRIMARY', 'title': 'Adjusted Mean Change From Baseline in Morning PEF (Peak Expiratory Flow) During the 4-week Treatment Periods', 'time_frame': 'Crossover Period Weeks 1-4, and 7-10', 'description': 'Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period \\[Weeks 1-4/Weeks 7-10\\]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out (i.e., the last 7 days prior to the day of starting treatment period \\[Weeks 1-4/Weeks 7-10\\]).'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 4-week Treatment Periods', 'time_frame': 'Crossover Period Weeks 1-4, 7-10', 'description': 'Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period \\[Weeks 1-4/Weeks 7-10\\]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 4-week Treatment Periods', 'time_frame': 'Crossover Period weeks 1-4, 7-10', 'description': 'Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period \\[Weeks 1-4/Weeks 7-10\\]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline in Evening PEF During the 4-week Treatment Periods', 'time_frame': 'Crossover Period weeks 1-4, 7-10', 'description': 'Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period \\[Weeks 1-4/Weeks 7-10\\]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline of Circadian Variation in Morning PEF(%) During the 4-week Treatment Periods', 'time_frame': 'Crossover Period Weeks 1-4, 7-10', 'description': 'Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period \\[Weeks 1-4/Weeks 7-10\\]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Symptom-Free Nights & Days', 'time_frame': 'Crossover Period Week 1-4, 7-10', 'description': 'Percentage of subjects with Symptom Free Nights \\& Days after 4 weeks of Treatment'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Rescue Medication-Free Nights and Days', 'time_frame': 'Crossover Period Weeks 1-4, 7-10', 'description': 'Percentage of subjects with Rescue Medication Free Nights \\& Days after 4 weeks of Treatment'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline in Morning PEF During the 20-week Extension Treatment Period', 'time_frame': 'Extension Period Weeks 11-30', 'description': 'Mean change from baseline = value at assessment period (mean of the values obtained at assessment period (Weeks 11-30).) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting of the Extension period (Weeks 11-30).'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 20-Week Extension Treatment Period', 'time_frame': 'Extension Period weeks 11-30', 'description': 'Mean change from baseline = value at assessment period (mean of the values obtained at assessment period \\[Weeks 11-30\\]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 20-week Extension Treatment Period', 'time_frame': 'Extension Period weeks 11-30', 'description': 'Mean change from baseline = value at assessment period (mean of the values obtained at assessment period \\[Weeks 11-30\\]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline in Evening PEF During the 20-week Extension Treatment Period', 'time_frame': 'Extension Period weeks 11-30', 'description': 'Mean change from baseline = value at assessment period (mean of the values obtained at assessment period \\[Weeks 11-30\\]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline of Circadian Variation in PEF(%) During the 20-Week Extension Treatment Period', 'time_frame': 'Extension Period weeks 11-30', 'description': 'Mean change from baseline = value at assessment period (mean of the values obtained at assessment period \\[Weeks 11-30\\]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Symptom-Free Nights & Days After 20 Weeks of Treatment', 'time_frame': 'Extension Period Weeks 11-30', 'description': 'Percentage of subjects with Symptom Free Nights \\& Days after 20 weeks of Treatment (at week 30).'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Rescue Medication-Free Nights & Days After 20 Weeks of Treatment', 'time_frame': 'Extension Period Weeks 11-30', 'description': 'Percentage of subjects with Rescue Medication Free Nights \\& Days after 20 weeks of Treatment (at week 30).'}], 'brief_summary': 'To evaluate the efficacy and safety of GW815SF HFA MDI 25/50µg 1 inhalation bid in comparison with concomitant treatment with salmeterol xinafoate DPI 25µg 1 inhalation bid plus fluticasone propionate DPI 50µg 1 inhalation bid in paediatric patients with asthma.\n\nTo evaluate the safety of long-term treatment of GW815SF HFA MDI 25/50µg 1 inhalation bid in paediatric patients with asthma.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'GlaxoSmithKline', 'results_first_posted_date': '2009-08-11', 'has_results_basis': 'results_first_posted_date'}→{'conditions': ['Bronchial Asthma'], 'countries': ['Japan'], 'interventions': [{'name': 'GW815SF HFA MDI', 'type': 'DRUG', 'description': 'salmeterol and fluticasone propionate combination', 'other_names': ['salmeterol/fluticasone propionate combination'], 'design_groups': [{'id': 421433981, 'type': 'ACTIVE_COMPARATOR', 'title': 'SLM+FP First', 'description': 'SLM(salmeterol) 25mcg + FP(fluticasone propionate) 50mcg twice daily in first intervention period and SFC(salmeterol/fluticasone propionate) 25/50mcg twice daily in second intervention period and (after washout period).'}, {'id': 421433982, 'type': 'ACTIVE_COMPARATOR', 'title': 'SFC First', 'description': 'SFC (Salmeterol/Fluticasone propionate combination) 25/50mcg twice daily in first intervention period and SLM (Salmeterol) 25mcg + FP (Fluticasone Propionate) 50mcg twice daily in second intervention period (after washout period).'}, {'id': 421433983, 'type': 'EXPERIMENTAL', 'title': 'SFC', 'description': 'SFC (salmeterol/fluticasone propionate combination) 25/50mcg twice daily in Extension period (after cross-over period).'}]}, {'name': 'salmeterol and fluticasone propionate', 'type': 'DRUG', 'description': 'salmeterol + fluticasone propionate', 'other_names': [], 'design_groups': [{'id': 421433981, 'type': 'ACTIVE_COMPARATOR', 'title': 'SLM+FP First', 'description': 'SLM(salmeterol) 25mcg + FP(fluticasone propionate) 50mcg twice daily in first intervention period and SFC(salmeterol/fluticasone propionate) 25/50mcg twice daily in second intervention period and (after washout period).'}, {'id': 421433982, 'type': 'ACTIVE_COMPARATOR', 'title': 'SFC First', 'description': 'SFC (Salmeterol/Fluticasone propionate combination) 25/50mcg twice daily in first intervention period and SLM (Salmeterol) 25mcg + FP (Fluticasone Propionate) 50mcg twice daily in second intervention period (after washout period).'}]}], 'composition_semantics': 'study_intervention_labels_not_product_formula', 'sponsors': [{'name': 'GlaxoSmithKline', 'role': 'lead', 'agency_class': 'INDUSTRY'}], 'facilities': [{'zip': '260-0001', 'city': 'Chiba', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Japan'}, {'zip': '245-0018', 'city': 'Kanagawa', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Japan'}, {'zip': '360-0018', 'city': 'Saitama', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Japan'}, {'zip': '360-0812', 'city': 'Saitama', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Japan'}, {'zip': '154-0002', 'city': 'Tokyo', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Japan'}, {'zip': '154-0017', 'city': 'Tokyo', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Japan'}, {'zip': '158-0083', 'city': 'Tokyo', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Japan'}, {'zip': '158-0097', 'city': 'Tokyo', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Japan'}], 'outcomes': [{'type': 'PRIMARY', 'title': 'Adjusted Mean Change From Baseline in Morning PEF (Peak Expiratory Flow) During the 4-week Treatment Periods', 'time_frame': 'Crossover Period Weeks 1-4, and 7-10', 'description': 'Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period \\[Weeks 1-4/Weeks 7-10\\]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out (i.e., the last 7 days prior to the day of starting treatment period \\[Weeks 1-4/Weeks 7-10\\]).'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 4-week Treatment Periods', 'time_frame': 'Crossover Period Weeks 1-4, 7-10', 'description': 'Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period \\[Weeks 1-4/Weeks 7-10\\]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 4-week Treatment Periods', 'time_frame': 'Crossover Period weeks 1-4, 7-10', 'description': 'Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period \\[Weeks 1-4/Weeks 7-10\\]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline in Evening PEF During the 4-week Treatment Periods', 'time_frame': 'Crossover Period weeks 1-4, 7-10', 'description': 'Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period \\[Weeks 1-4/Weeks 7-10\\]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline of Circadian Variation in Morning PEF(%) During the 4-week Treatment Periods', 'time_frame': 'Crossover Period Weeks 1-4, 7-10', 'description': 'Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period \\[Weeks 1-4/Weeks 7-10\\]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Symptom-Free Nights & Days', 'time_frame': 'Crossover Period Week 1-4, 7-10', 'description': 'Percentage of subjects with Symptom Free Nights \\& Days after 4 weeks of Treatment'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Rescue Medication-Free Nights and Days', 'time_frame': 'Crossover Period Weeks 1-4, 7-10', 'description': 'Percentage of subjects with Rescue Medication Free Nights \\& Days after 4 weeks of Treatment'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline in Morning PEF During the 20-week Extension Treatment Period', 'time_frame': 'Extension Period Weeks 11-30', 'description': 'Mean change from baseline = value at assessment period (mean of the values obtained at assessment period (Weeks 11-30).) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting of the Extension period (Weeks 11-30).'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 20-Week Extension Treatment Period', 'time_frame': 'Extension Period weeks 11-30', 'description': 'Mean change from baseline = value at assessment period (mean of the values obtained at assessment period \\[Weeks 11-30\\]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 20-week Extension Treatment Period', 'time_frame': 'Extension Period weeks 11-30', 'description': 'Mean change from baseline = value at assessment period (mean of the values obtained at assessment period \\[Weeks 11-30\\]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline in Evening PEF During the 20-week Extension Treatment Period', 'time_frame': 'Extension Period weeks 11-30', 'description': 'Mean change from baseline = value at assessment period (mean of the values obtained at assessment period \\[Weeks 11-30\\]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline of Circadian Variation in PEF(%) During the 20-Week Extension Treatment Period', 'time_frame': 'Extension Period weeks 11-30', 'description': 'Mean change from baseline = value at assessment period (mean of the values obtained at assessment period \\[Weeks 11-30\\]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Symptom-Free Nights & Days After 20 Weeks of Treatment', 'time_frame': 'Extension Period Weeks 11-30', 'description': 'Percentage of subjects with Symptom Free Nights \\& Days after 20 weeks of Treatment (at week 30).'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Rescue Medication-Free Nights & Days After 20 Weeks of Treatment', 'time_frame': 'Extension Period Weeks 11-30', 'description': 'Percentage of subjects with Rescue Medication Free Nights \\& Days after 20 weeks of Treatment (at week 30).'}], 'brief_summary': 'To evaluate the efficacy and safety of GW815SF HFA MDI 25/50µg 1 inhalation bid in comparison with concomitant treatment with salmeterol xinafoate DPI 25µg 1 inhalation bid plus fluticasone propionate DPI 50µg 1 inhalation bid in paediatric patients with asthma.\n\nTo evaluate the safety of long-term treatment of GW815SF HFA MDI 25/50µg 1 inhalation bid in paediatric patients with asthma.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'GlaxoSmithKline', 'results_first_posted_date': '2009-08-11', 'has_results_basis': 'results_first_posted_date', 'start_date_type': None, 'start_month_year': '2007-04', 'start_date_precision': 'month', 'completion_date_type': 'ACTUAL', 'completion_month_year': '2008-01', 'completion_date_precision': 'month', 'primary_completion_date': '2008-01-31', 'primary_completion_month_year': '2008-01', 'primary_completion_date_precision': 'month', 'primary_completion_date_type': 'ACTUAL', 'intervention_component_groups': [['unmapped:gw815sf-hfa-mdi'], ['fluticasone', 'salmeterol']], 'intervention_normalization': [{'name': 'GW815SF HFA MDI', 'selected_label': 'GW815SF HFA MDI', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['unmapped:gw815sf-hfa-mdi'], 'unverified_label_components': ['unmapped:gw815sf-hfa-mdi'], 'items': [{'original': 'GW815SF HFA MDI', 'component': 'unmapped:gw815sf-hfa-mdi', 'status': 'unresolved', 'method': 'no_verified_mapping'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}, {'name': 'salmeterol and fluticasone propionate', 'selected_label': 'salmeterol and fluticasone propionate', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['fluticasone', 'salmeterol'], 'unverified_label_components': [], 'items': [{'original': 'salmeterol', 'component': 'salmeterol', 'status': 'resolved', 'method': 'versioned_lexicon'}, {'original': 'fluticasone propionate', 'component': 'fluticasone', 'status': 'resolved', 'method': 'versioned_lexicon'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}]}