Ignite Creation Date:
2025-12-24 @ 10:42 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT00448435
Status:
COMPLETED
Last Update Posted:
2010-06-08
First Post:
2007-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Assessment Of GW815SF HFA MDI In Pediatric Patients With Bronchial Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068297', 'term': 'Fluticasone-Salmeterol Drug Combination'}], 'ancestors': [{'id': 'D000068299', 'term': 'Salmeterol Xinafoate'}, {'id': 'D000420', 'term': 'Albuterol'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000068298', 'term': 'Fluticasone'}, {'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit an investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not preceed the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'SFC 50/100 Mcg/Day', 'description': 'Safety Population who received GW815SF (SFC, Salmeterol/Fluticasone Propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily in Crossover Period Weeks 1-4 and 7-10', 'otherNumAtRisk': 51, 'otherNumAffected': 12, 'seriousNumAtRisk': 51, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'SLM 50 + FP 100 Mcg/Day', 'description': 'Safety Population who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily in Crossover Period Weeks 1-4 and 7-10', 'otherNumAtRisk': 50, 'otherNumAffected': 10, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'SFC 50/100mcg/Day (Extension Period)', 'description': 'Safety Population who switched to Extension Period and received GW815SF HFA MDI 25/50mcg twice daily during the Extension period', 'otherNumAtRisk': 51, 'otherNumAffected': 35, 'seriousNumAtRisk': 51, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Upper Respiratory Tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adjusted Mean Change From Baseline in Morning PEF (Peak Expiratory Flow) During the 4-week Treatment Periods', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SFC 50/100 Mcg/Day', 'description': 'Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily'}, {'id': 'OG001', 'title': 'SLM 50 Mcg + FP 100 Mcg/Day', 'description': 'Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '14.3', 'spread': '4.53', 'groupId': 'OG000'}, {'value': '17.1', 'spread': '4.53', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6383', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '2.8', 'ciLowerLimit': '-9.10', 'ciUpperLimit': '14.69', 'pValueComment': 'Confidence Interval', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.91', 'groupDescription': 'Difference between treatments \\[(SLM + FP)- SFC\\](SE) 2.8 (5.91)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Equivalence margin + or - 15 L/min'}], 'paramType': 'MEAN', 'timeFrame': '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\\]).', 'unitOfMeasure': 'Liters/minute', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS (Per Protocol Set): randomized subjects less those who did not complete treatment.'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 4-week Treatment Periods', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SFC 50/100 Mcg/Day', 'description': 'Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily'}, {'id': 'OG001', 'title': 'SLM 50 Mcg + FP 100 Mcg/Day', 'description': 'Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '5.38', 'spread': '1.543', 'groupId': 'OG000'}, {'value': '6.73', 'spread': '1.543', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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.', 'unitOfMeasure': 'Percentage of predicted value', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 4-week Treatment Periods', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SFC 50/100 Mcg/Day', 'description': 'Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily'}, {'id': 'OG001', 'title': 'SLM 50mcg + FP 100 Mcg/Day', 'description': 'Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg + FP (Fluticasone Propionate) DPI 50 mcg twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '5.01', 'spread': '1.480', 'groupId': 'OG000'}, {'value': '6.46', 'spread': '1.480', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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.', 'unitOfMeasure': 'Percentage of personal best value', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline in Evening PEF During the 4-week Treatment Periods', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SFC 50/100 Mcg/Day', 'description': 'Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily'}, {'id': 'OG001', 'title': 'SLM 50 Mcg + FP 100 Mcg/Day', 'description': 'Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '16.3', 'spread': '3.74', 'groupId': 'OG000'}, {'value': '15.8', 'spread': '3.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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.', 'unitOfMeasure': 'L/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline of Circadian Variation in Morning PEF(%) During the 4-week Treatment Periods', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SFC 50/100 Mcg/Day', 'description': 'Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily'}, {'id': 'OG001', 'title': 'SLM 50 Mcg + FP 100 Mcg/Day', 'description': 'Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.06', 'spread': '0.638', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.638', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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.', 'unitOfMeasure': 'Percentage of circadian variation', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Symptom-Free Nights & Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SFC 50/100 Mcg/Day', 'description': 'Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily'}, {'id': 'OG001', 'title': 'SLM 50 Mcg + FP 100 Mcg/Day', 'description': 'Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '72.9', 'groupId': 'OG000'}, {'value': '81.3', 'groupId': 'OG001'}]}]}, {'title': 'After 4 Weeks of Treatment', 'categories': [{'measurements': [{'value': '91.7', 'groupId': 'OG000'}, {'value': '81.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Crossover Period Week 1-4, 7-10', 'description': 'Percentage of subjects with Symptom Free Nights \\& Days after 4 weeks of Treatment', 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Rescue Medication-Free Nights and Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SFC 50/100 Mcg/Day', 'description': 'Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily'}, {'id': 'OG001', 'title': 'SLM 50 Mcg + FP 100 Mcg/Day', 'description': 'Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000'}, {'value': '87.5', 'groupId': 'OG001'}]}]}, {'title': 'After 4 Weeks of Treatment', 'categories': [{'measurements': [{'value': '93.8', 'groupId': 'OG000'}, {'value': '87.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Crossover Period Weeks 1-4, 7-10', 'description': 'Percentage of subjects with Rescue Medication Free Nights \\& Days after 4 weeks of Treatment', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline in Morning PEF During the 20-week Extension Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SFC 50/100 Mcg/Day', 'description': 'Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '24.56', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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).', 'unitOfMeasure': 'L/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 20-Week Extension Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SFC 50/100 Mcg/Day', 'description': 'Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '1.46', 'spread': '9.568', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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).', 'unitOfMeasure': 'Percentage of predicted value', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 20-week Extension Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SFC 50/100 Mcg/Day', 'description': 'Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '1.29', 'spread': '8.541', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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).', 'unitOfMeasure': 'Percentage of personal best value', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline in Evening PEF During the 20-week Extension Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SFC 50/100 Mcg/Day', 'description': 'Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'spread': '23.43', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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).', 'unitOfMeasure': 'L/Min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Full Analysis Set) during the Exension period: all subjects switched to Extension period and received GW815SF HFA MDI.'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Change From Baseline of Circadian Variation in PEF(%) During the 20-Week Extension Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SFC 50/100 Mcg/Day', 'description': 'Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.37', 'spread': '3.568', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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).', 'unitOfMeasure': 'Percentage of circadian variation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Symptom-Free Nights & Days After 20 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SFC 50/100 Mcg/Day', 'description': 'Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '84.0', 'groupId': 'OG000'}]}]}, {'title': 'After 20 weeks of treatment (at week 30)', 'categories': [{'measurements': [{'value': '84.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Extension Period Weeks 11-30', 'description': 'Percentage of subjects with Symptom Free Nights \\& Days after 20 weeks of Treatment (at week 30).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Rescue Medication-Free Nights & Days After 20 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SFC 50/100 Mcg/Day', 'description': 'Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '90.0', 'groupId': 'OG000'}]}]}, {'title': 'After 20 weeks of treatment (at week 30)', 'categories': [{'measurements': [{'value': '89.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Extension Period Weeks 11-30', 'description': 'Percentage of subjects with Rescue Medication Free Nights \\& Days after 20 weeks of Treatment (at week 30).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SFC 50/100 Mcg/Day First', 'description': 'GW815SF (SFC; Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily in first intervention period and SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg + FP (Fluticasone Propionate) DPI 50 mcg twice daily in second intervention period (after washout period).'}, {'id': 'FG001', 'title': 'SLM 50 Mcg + FP 100 Mcg/Day First', 'description': 'SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg + FP (Fluticasone Propionate) DPI 50 mcg twice daily in first intervention period and GW815SF (SFC; Salmeterol/Fluticasone Propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily in second intervention period (after washout period).'}], 'periods': [{'title': 'Treatment Period I - 4 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout Period - 2 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period II - 4 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Extension Period - 20 Weeks', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study Population', 'description': 'Randomized Population'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'spread': '2.41', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian-Japanese Heritage', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-03', 'studyFirstSubmitDate': '2007-03-14', 'resultsFirstSubmitDate': '2009-01-19', 'studyFirstSubmitQcDate': '2007-03-15', 'lastUpdatePostDateStruct': {'date': '2010-06-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-06-25', 'studyFirstPostDateStruct': {'date': '2007-03-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adjusted Mean Change From Baseline in Morning PEF (Peak Expiratory Flow) During the 4-week Treatment Periods', 'timeFrame': '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\\]).'}], 'secondaryOutcomes': [{'measure': 'Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 4-week Treatment Periods', 'timeFrame': '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.'}, {'measure': 'Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 4-week Treatment Periods', 'timeFrame': '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.'}, {'measure': 'Adjusted Mean Change From Baseline in Evening PEF During the 4-week Treatment Periods', 'timeFrame': '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.'}, {'measure': 'Adjusted Mean Change From Baseline of Circadian Variation in Morning PEF(%) During the 4-week Treatment Periods', 'timeFrame': '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.'}, {'measure': 'Percentage of Subjects With Symptom-Free Nights & Days', 'timeFrame': 'Crossover Period Week 1-4, 7-10', 'description': 'Percentage of subjects with Symptom Free Nights \\& Days after 4 weeks of Treatment'}, {'measure': 'Percentage of Subjects With Rescue Medication-Free Nights and Days', 'timeFrame': 'Crossover Period Weeks 1-4, 7-10', 'description': 'Percentage of subjects with Rescue Medication Free Nights \\& Days after 4 weeks of Treatment'}, {'measure': 'Adjusted Mean Change From Baseline in Morning PEF During the 20-week Extension Treatment Period', 'timeFrame': '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).'}, {'measure': 'Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 20-Week Extension Treatment Period', 'timeFrame': '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).'}, {'measure': 'Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 20-week Extension Treatment Period', 'timeFrame': '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).'}, {'measure': 'Adjusted Mean Change From Baseline in Evening PEF During the 20-week Extension Treatment Period', 'timeFrame': '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).'}, {'measure': 'Adjusted Mean Change From Baseline of Circadian Variation in PEF(%) During the 20-Week Extension Treatment Period', 'timeFrame': '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).'}, {'measure': 'Percentage of Subjects With Symptom-Free Nights & Days After 20 Weeks of Treatment', 'timeFrame': 'Extension Period Weeks 11-30', 'description': 'Percentage of subjects with Symptom Free Nights \\& Days after 20 weeks of Treatment (at week 30).'}, {'measure': 'Percentage of Subjects With Rescue Medication-Free Nights & Days After 20 Weeks of Treatment', 'timeFrame': 'Extension Period Weeks 11-30', 'description': 'Percentage of subjects with Rescue Medication Free Nights \\& Days after 20 weeks of Treatment (at week 30).'}]}, 'conditionsModule': {'keywords': ['Salmeterol', 'Fluticasone propionate', 'Salmeterol/Fluticasone propionate combination', 'Pediatric bronchial asthma'], 'conditions': ['Bronchial Asthma']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Inclusion Criteria for Entry in Run-in Period\n\nA pediatric patient already diagnosed as having bronchial asthma who meets all of the following criteria is eligible for the study:\n\n* Male or female patients aged ≥5 and ≤14 years. Enrolment of a female patient of childbearing potential is allowed only if she is tested negative in the pregnancy testing at the start of Treatment Period 1 and if she agrees to undergo pregnancy testing at the protocol-specified timings and to take contraceptive measures without fail.\n* Written informed consent must be obtained from a legally acceptable representative of the subject. Consent of the subject him/herself should also be obtained, wherever possible, after giving an explanation in an as easy to understand as possible manner.\n* An outpatient who has been treated with ICS (FP 100μg/day or equivalent) for at least 4 weeks prior to Visit 1.\n* Able to use a peak flow meter in a correct manner in the investigator's/subinvestigator's judgment.\n* Able to use MDI and DPI in a correct manner (with the assistance of his/her caregiver as necessary) in the investigator's/subinvestigator's judgment.\n\nInclusion Criteria for Entry in Treatment Period 1 A subject will be randomized to one of the two treatment groups only if he/she has completed the run-in period and meets all the following criteria.\n\n1. Has a mean of morning PEF measurements in the last 7 days of the run-in period (excluding the first day of Treatment Period 1) ≤90% of his/her best PEF measurement .\n2. Was able to perform entry in the asthma diary and PEF measurements in a correct manner in the investigator's/subinvestigator's judgment.\n3. Able to use MDI and DPI in a correct manner (with the assistance of his/her caregiver as necessary) in the investigator's/subinvestigator's judgment.\n\nExclusion criteria:\n\n* Exclusion Criteria for Entry in Run-in Period\n\nA patient who applies any of the following criteria is not eligible for the study:\n\n* Admitted to the hospital due to asthma exacerbation within 8 weeks prior to Visit 1.\n* Used systemic steroid within 4 weeks prior to Visit 1.\n* Received antibacterials or antivirals for treatment of upper or lower respiratory tract infection within 2 weeks prior to Visit 1.\n* Has a safety problem in participation in the study because of a serious, uncontrolled systemic disease including nervous system disorder.\n* Has or is suspected to have deep-seated mycosis or infection to which no effective antibacterial agent is available.\n* Has or is suspected to have hypersensitivity to the investigational product, rescue medication or any ingredients of them.\n* Is pregnant or lactating, may be pregnant, or plans for pregnancy during the study period.\n* Has received the last dose in another clinical study within 2 months prior to this study.\n* Is not eligible for the study in the investigator's/subinvestigator's judgment.\n\nExclusion Criteria for Entry in Treatment Period 1\n\nEnrolment of a subject completing the run-in period into Treatment Period 1 will not be allowed if any of the following applies:\n\n1. Admitted to the hospital due to asthma exacerbation during the run-in period.\n2. Had upper or lower respiratory tract infection during the 2 weeks just before Visit 2.\n3. Used prohibited drugs during the 2 weeks just before Visit 2.\n4. Is not eligible for the study in the investigator's/subinvestigator's judgment.\n\nExclusion Criteria for Entry in Treatment Period 2\n\nEnrolment of a subject completing the washout period into Treatment Period 2 will not be allowed if any of the following applies:\n\n1. Admitted to the hospital due to asthma exacerbation during the washout period.\n2. Had upper or lower respiratory tract infection during the 2 weeks just before Visit 4.\n3. Used prohibited drugs during the 2 weeks just before Visit 4.\n4. Is not eligible for entry in Treatment Period 2 in the investigator's/subinvestigator's judgment."}, 'identificationModule': {'nctId': 'NCT00448435', 'briefTitle': 'Clinical Assessment Of GW815SF HFA MDI In Pediatric Patients With Bronchial Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Study to Compare GW815SF HFA MDI With Concomitant Treatment With Salmeterol Xinafoate DPI Plus Fluticasone Propionate DPI and to Assess Long-term Safety of GW815SF HFA MDI', 'orgStudyIdInfo': {'id': '110099'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '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).', 'interventionNames': ['Drug: GW815SF HFA MDI', 'Drug: salmeterol and fluticasone propionate']}, {'type': 'ACTIVE_COMPARATOR', 'label': '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).', 'interventionNames': ['Drug: GW815SF HFA MDI', 'Drug: salmeterol and fluticasone propionate']}, {'type': 'EXPERIMENTAL', 'label': 'SFC', 'description': 'SFC (salmeterol/fluticasone propionate combination) 25/50mcg twice daily in Extension period (after cross-over period).', 'interventionNames': ['Drug: GW815SF HFA MDI']}], 'interventions': [{'name': 'GW815SF HFA MDI', 'type': 'DRUG', 'otherNames': ['salmeterol/fluticasone propionate combination'], 'description': 'salmeterol and fluticasone propionate combination', 'armGroupLabels': ['SFC', 'SFC First', 'SLM+FP First']}, {'name': 'salmeterol and fluticasone propionate', 'type': 'DRUG', 'description': 'salmeterol + fluticasone propionate', 'armGroupLabels': ['SFC First', 'SLM+FP First']}]}, 'contactsLocationsModule': {'locations': [{'zip': '260-0001', 'city': 'Chiba', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '245-0018', 'city': 'Kanagawa', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'zip': '360-0018', 'city': 'Saitama', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '360-0812', 'city': 'Saitama', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '154-0002', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '154-0017', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '158-0083', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '158-0097', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'GSK'}}}}