Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-29 @ 5:47 PM
Study NCT ID:
NCT01332357
Status:
COMPLETED
Last Update Posted:
2017-07-06
First Post:
2011-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Use of Fluticasone Propionate/Salmeterol Combination Post Emergency Department Visit
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D004630', 'term': 'Emergencies'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068298', 'term': 'Fluticasone'}], 'ancestors': [{'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'}]}}, '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 is a retrospective study of pre-existing medical records and/or health insurance claims data; all data are de-identified, and thus no assessments of Serious or Non-serious Adverse Events are possible.', 'eventGroups': [{'id': 'EG000', 'title': 'Total Population', 'description': 'Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With an Asthma-related Event Occurring Between 1 and 6 Months Following the Index Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6139', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Population', 'description': 'Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.'}], 'classes': [{'categories': [{'measurements': [{'value': '915', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.96', 'ciLowerLimit': '1.56', 'ciUpperLimit': '2.46', 'pValueComment': 'The unadjusted risk of experiencing a recurrent event associated with not initiating a controller medication at index event discharge', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.79', 'ciLowerLimit': '1.42', 'ciUpperLimit': '2.25', 'pValueComment': 'The adjusted risk of experiencing a recurrent event associated with not initiating a controller medication at index event discharge', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Covariates included demographics, IP or ED index event, primary asthma diagnosis, Charlson score, and pre-index medication'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.008', 'ciLowerLimit': '1.005', 'ciUpperLimit': '1.011', 'pValueComment': 'The risk of experiencing a recurrent event associated with not initiating a controller medication at index event discharge by time interaction', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Evaluates the impact of each day treatment with a controller was delayed'}], 'paramType': 'NUMBER', 'timeFrame': 'Data were collected during a 4-year period from January 1, 2004 to December 31, 2008.', 'description': 'A subsequent asthma-related inpatient (IP) visit or emergency department (ED) visit were defined as visits within 6 months of the index event. The index event was defined as an asthma-related hospitalization or ED visit occuring between 2004 and 2008.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Total Population', 'description': 'Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6139'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6139'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Participants 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 cohort. All diagnoses and treatments are recorded in the course of routine medical practice.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6139', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Total Population', 'description': 'Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '22.36', 'spread': '17.30', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3392', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2747', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Type of Index Event', 'classes': [{'title': 'Inpatient hospitalizations', 'categories': [{'measurements': [{'value': '1331', 'groupId': 'BG000'}]}]}, {'title': 'Emergency Department Visit', 'categories': [{'measurements': [{'value': '4808', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'The number of inpatient visits and emergency department visits that defined the index event are reported.', 'unitOfMeasure': 'visits'}, {'title': 'Charlson Comorbidity Index Scores', 'classes': [{'categories': [{'measurements': [{'value': '1.14', 'spread': '0.57', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The Charlson Comorbidity Index estimates 10-year mortality risk. Scores range from 0 - 37, with a lower score indicating a higher chance of survival.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-06', 'studyFirstSubmitDate': '2011-04-07', 'resultsFirstSubmitDate': '2011-09-08', 'studyFirstSubmitQcDate': '2011-04-07', 'lastUpdatePostDateStruct': {'date': '2017-07-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-09-08', 'studyFirstPostDateStruct': {'date': '2011-04-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With an Asthma-related Event Occurring Between 1 and 6 Months Following the Index Event', 'timeFrame': 'Data were collected during a 4-year period from January 1, 2004 to December 31, 2008.', 'description': 'A subsequent asthma-related inpatient (IP) visit or emergency department (ED) visit were defined as visits within 6 months of the index event. The index event was defined as an asthma-related hospitalization or ED visit occuring between 2004 and 2008.'}]}, 'conditionsModule': {'keywords': ['fluticasone/propionate salmeterol combination', 'hospitalization', 'emergency department', 'asthma'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare readmission to the emergency department for asthma in asthma patients who receive treatment with fluticasone propionate and salmeterol oral inhaler after an initial emergency department visit using a retrospective observational cohort study design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study intends to identify subjects with asthma discharged from an emergency department that received fluticasone propionate/salmeterol from either an ED physician or from an outpatient physician', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with asthma as determined by ICD-9 codes and asthma drug use\n* at least 12 years of age\n* discharged from an initial Emergency Department visit within 12 months\n\nExclusion Criteria:\n\n* Subjects with COPD or treatment for COPD'}, 'identificationModule': {'nctId': 'NCT01332357', 'briefTitle': 'Use of Fluticasone Propionate/Salmeterol Combination Post Emergency Department Visit', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Use of Fluticasone Propionate/Salmeterol Combination Post Emergency Department Visit', 'orgStudyIdInfo': {'id': '112606'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fluticasone propionate/salmeterol combination ED MD', 'description': 'Asthma subjects discharged from an institution after treatment for severe asthma exacerbation that receive fluticasone propionate/salmeterol combination from the ED physician', 'interventionNames': ['Drug: Fluticasone propionate/salmeterol combination ED MD']}, {'label': 'Fluticasone propionate/salmeterol combination OP MD', 'description': 'Asthma subjects discharged from an institution after treatment for severe asthma exacerbation that receive fluticasone propionate/salmeterol combination from the OP physician', 'interventionNames': ['Drug: Fluticasone propionate/salmeterol combination OP MD']}], 'interventions': [{'name': 'Fluticasone propionate/salmeterol combination ED MD', 'type': 'DRUG', 'description': 'Receipt of fluticasone propionate/salmeterol combination from the ED physician', 'armGroupLabels': ['Fluticasone propionate/salmeterol combination ED MD']}, {'name': 'Fluticasone propionate/salmeterol combination OP MD', 'type': 'DRUG', 'description': 'Receipt of fluticasone propionate/salmeterol combination from the OP physician', 'armGroupLabels': ['Fluticasone propionate/salmeterol combination OP MD']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}