Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 4:09 AM
Study NCT ID:
NCT01347060
Status:
COMPLETED
Last Update Posted:
2017-05-25
First Post:
2010-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Outcomes for Medicare Asthma Patients Taking Fluticasone Propionate/Salmeterol Xinafoate Combination Versus Inhaled Corticosteroids or Other Combination Therapy
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 any 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 precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'This was a retrospective observational study using a large health insurance claims database. Serious adverse events and non-serious adverse events were not collected.', 'eventGroups': [{'id': 'EG000', 'title': 'Fluticasone Propionate and Salmeterol', 'description': 'Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Inhaled Corticosteroids', 'description': 'Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9868', 'groupId': 'OG000'}, {'value': '7580', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Propionate and Salmeterol', 'description': 'Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg'}, {'id': 'OG001', 'title': 'Inhaled Corticosteroids', 'description': 'Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.'}], 'classes': [{'title': 'Inpatient visits', 'categories': [{'measurements': [{'value': '0.033', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '0.046', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': 'Emergency department visits', 'categories': [{'measurements': [{'value': '0.022', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '0.027', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': 'Inpatient/emergency department visits', 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0051', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.68', 'ciUpperLimit': '0.93', 'pValueComment': 'The P-value relates to differences in combined inpatient/emergency department.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline differences'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 7 years from July 1, 2001 to June 30, 2008', 'description': 'Asthma-related events were defined as events with any primary ICD-9 code of 493.xx for hospitalizations, emergency department visits, and combined hospitalization/emergency department visits. The post-index period is defined as 3-12 months after either the first administration of fluticasone propionate and salmetrol or inhaled corticosteroids. Medical and pharmacy claims are recorded healthcare encounters in a large managed care administrative insurance database.', 'unitOfMeasure': 'Asthma-related events', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants contributing to the PharMetrics database (a large, multiplan insurance encounter database) who were identified in the study as having at least one pharmacy claim for fluticasone propionate/salmeterol or inhaled corticosteroids, had an ICD-9 code of 493.xx for asthma, and were at least 65 years of age within the time frame of the study.'}, {'type': 'SECONDARY', 'title': 'Mean Asthma-related Costs in the Post-index Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9868', 'groupId': 'OG000'}, {'value': '7580', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Propionate and Salmeterol', 'description': 'Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg'}, {'id': 'OG001', 'title': 'Inhaled Corticosteroids', 'description': 'Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.'}], 'classes': [{'title': 'Medical Services Costs', 'categories': [{'measurements': [{'value': '381', 'spread': '2859', 'groupId': 'OG000'}, {'value': '462', 'spread': '2859', 'groupId': 'OG001'}]}]}, {'title': 'Pharmacy Costs', 'categories': [{'measurements': [{'value': '1128', 'spread': '1077', 'groupId': 'OG000'}, {'value': '939', 'spread': '1125', 'groupId': 'OG001'}]}]}, {'title': 'Total Asthma Costs', 'categories': [{'measurements': [{'value': '1509', 'spread': '3832', 'groupId': 'OG000'}, {'value': '1401', 'spread': '3151', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '883.23', 'ciLowerLimit': '731.66', 'ciUpperLimit': '1041.69', 'pValueComment': 'The P-value is on the adjusted difference in total asthma costs.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Generalized Linear Model with a log-link and a gamma distribution adjusting for differences at baseline'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 7 years from July 1, 2001 to June 30, 2008', 'description': 'Asthma-related costs were calculated as pharmacy costs, medical costs, and total asthma (pharmacy plus medical) costs. Medical costs were made up of asthma-related visits, hospitalizations, emergency department visits, and medical office visits. Pharmacy costs were comprised of all asthma-related medications used during the follow-up period. Medical services were identified by place of service and PharMetrics-specific confinement codes. Prescriptions were counted by 30-day fills, with fills less than 30 days rounded up to indicate one fill.', 'unitOfMeasure': 'United States dollars', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants contributing to the PharMetrics database (a large, multiplan insurance encounter database) who were identified in the study as having at least one pharmacy claim for fluticasone propionate/salmeterol or inhaled corticosteroids, had an ICD-9 code of 493.xx for asthma, and were at least 65 years of age within the time frame of the study.'}, {'type': 'SECONDARY', 'title': 'Mean Number of Albuterol (Short-acting β-Agonists) Canisters Dispensed Per Pharmacy Claim Per Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9868', 'groupId': 'OG000'}, {'value': '7580', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone Propionate and Salmeterol', 'description': 'Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg'}, {'id': 'OG001', 'title': 'Inhaled Corticosteroids', 'description': 'Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.01', 'spread': '2.26', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '2.95', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 7 years from July 1, 2001 to June 30, 2008', 'description': 'The number of albuterol canisters dispensed was used as a surrogate marker of asthma symptoms.', 'unitOfMeasure': 'albuterol canisters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants contributing to the PharMetrics database (a large, multiplan insurance encounter database) who were identified in the study as having at least one pharmacy claim for fluticasone propionate/salmeterol or inhaled corticosteroids, had an ICD-9 code of 493.xx for asthma, and were at least 65 years of age within the time frame of the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fluticasone Propionate and Salmeterol', 'description': 'Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg'}, {'id': 'FG001', 'title': 'Inhaled Corticosteroids', 'description': 'Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9868'}, {'groupId': 'FG001', 'numSubjects': '7580'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9868'}, {'groupId': 'FG001', 'numSubjects': '7580'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymized and used to develop a patient cohort. All diagnoses and treatments are recorded in the course of routine medical practice.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9868', 'groupId': 'BG000'}, {'value': '7580', 'groupId': 'BG001'}, {'value': '17448', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fluticasone Propionate and Salmeterol', 'description': 'Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg'}, {'id': 'BG001', 'title': 'Inhaled Corticosteroids', 'description': 'Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '65-69 years old', 'categories': [{'measurements': [{'value': '4153', 'groupId': 'BG000'}, {'value': '3064', 'groupId': 'BG001'}, {'value': '7217', 'groupId': 'BG002'}]}]}, {'title': '70-74 years old', 'categories': [{'measurements': [{'value': '2694', 'groupId': 'BG000'}, {'value': '2669', 'groupId': 'BG001'}, {'value': '5363', 'groupId': 'BG002'}]}]}, {'title': '75-79 years old', 'categories': [{'measurements': [{'value': '3021', 'groupId': 'BG000'}, {'value': '1847', 'groupId': 'BG001'}, {'value': '4868', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6083', 'groupId': 'BG000'}, {'value': '4800', 'groupId': 'BG001'}, {'value': '10883', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3785', 'groupId': 'BG000'}, {'value': '2780', 'groupId': 'BG001'}, {'value': '6565', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants with comorbid COPD at baseline', 'classes': [{'categories': [{'measurements': [{'value': '9227', 'groupId': 'BG000'}, {'value': '7153', 'groupId': 'BG001'}, {'value': '16380', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'International Classification of Disease-9 (ICD-9) codes 491, 492, 496, 490-492.8, 493.00-493.91, 494, 495.0-505, 506.4', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17448}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-23', 'studyFirstSubmitDate': '2010-06-10', 'resultsFirstSubmitDate': '2011-05-05', 'studyFirstSubmitQcDate': '2011-05-03', 'lastUpdatePostDateStruct': {'date': '2017-05-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-05-05', 'studyFirstPostDateStruct': {'date': '2011-05-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims', 'timeFrame': 'Up to 7 years from July 1, 2001 to June 30, 2008', 'description': 'Asthma-related events were defined as events with any primary ICD-9 code of 493.xx for hospitalizations, emergency department visits, and combined hospitalization/emergency department visits. The post-index period is defined as 3-12 months after either the first administration of fluticasone propionate and salmetrol or inhaled corticosteroids. Medical and pharmacy claims are recorded healthcare encounters in a large managed care administrative insurance database.'}], 'secondaryOutcomes': [{'measure': 'Mean Asthma-related Costs in the Post-index Period', 'timeFrame': 'Up to 7 years from July 1, 2001 to June 30, 2008', 'description': 'Asthma-related costs were calculated as pharmacy costs, medical costs, and total asthma (pharmacy plus medical) costs. Medical costs were made up of asthma-related visits, hospitalizations, emergency department visits, and medical office visits. Pharmacy costs were comprised of all asthma-related medications used during the follow-up period. Medical services were identified by place of service and PharMetrics-specific confinement codes. Prescriptions were counted by 30-day fills, with fills less than 30 days rounded up to indicate one fill.'}, {'measure': 'Mean Number of Albuterol (Short-acting β-Agonists) Canisters Dispensed Per Pharmacy Claim Per Participant', 'timeFrame': 'Up to 7 years from July 1, 2001 to June 30, 2008', 'description': 'The number of albuterol canisters dispensed was used as a surrogate marker of asthma symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma', 'treatment', 'Advair and inhaled corticosteroids', 'Medicare', 'Outcomes', 'costs'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare healthcare utilization and costs in Medicare-eligible asthma patients (aged \\>65) who receive fluticasone propionate/salmeterol xinafoate combination or inhaled corticosteroids in a typical clinical practice using a retrospective observational cohort study design of large managed care database. Outcomes on interest include asthma related severe exacerbations defined as asthma related emergency department visits, hospitalizations or combined emergency department/hospitalization. Other outcomes of interest include use of albuterol, oral corticosteroids and overall asthma related costs. Outcomes of interest will be compared between the two treatment cohorts (fluticasone propionate/salmeterol xinafoate combination or inhaled corticosteroids). Dichotomous outcomes (emergency visits, hospitalizations etc) will be compared using Cox regression hazards analysis assessing time to first event for each asthma related endpoint adjusting for differences in baseline demographics such as age, gender, previous asthma medication use, co morbidities, costs, and plan demographics. Total asthma related costs will also be compared using generalized linear models adjusting for baseline differences.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Medicare-eligible subjects age 65 years and older with a diagnosis of asthma being treated with an inhaled corticosteroid', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with asthma as determined by ICD-9 codes and asthma drug use\n* at least 65 years of age\n* prescription for an inhaled corticosteroid\n\nExclusion Criteria:\n\n* a diagnosis of chronic obstructive pulmonary disease or\n* a prescription for a chronic obstructive pulmonary disease treatment'}, 'identificationModule': {'nctId': 'NCT01347060', 'briefTitle': 'Outcomes for Medicare Asthma Patients Taking Fluticasone Propionate/Salmeterol Xinafoate Combination Versus Inhaled Corticosteroids or Other Combination Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Outcomes for Medicare Asthma Patients Taking Fluticasone Propionate/Salmeterol Xinafoate Combination Versus Inhaled Corticosteroids or Other Combination Therapy', 'orgStudyIdInfo': {'id': '112605'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Medicare-eligible subjects with asthma', 'description': 'Asthma subjects at least 65 years of age enrolled in a large Medicare managed care health plan.', 'interventionNames': ['Drug: fluticasone propionate/salmeterol xinafoate combination', 'Drug: inhaled corticosteroids']}], 'interventions': [{'name': 'fluticasone propionate/salmeterol xinafoate combination', 'type': 'DRUG', 'otherNames': ['Advair (TM)'], 'description': 'Fluticasone propionate/salmeterol xinafoate combination for asthma, all doses (100mcg/50mcg, 250 mcg/50mcg and 500 mcg/50mcg)', 'armGroupLabels': ['Medicare-eligible subjects with asthma']}, {'name': 'inhaled corticosteroids', 'type': 'DRUG', 'description': 'Inhaled corticosteroids: beclomethasone dipropionte, mometasone, fluticasone propionate, budesonide, and flunisolide', 'armGroupLabels': ['Medicare-eligible subjects with asthma']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}