Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2025-12-29 @ 9:23 PM
Study NCT ID:
NCT01216735
Status:
COMPLETED
Last Update Posted:
2016-06-29
First Post:
2010-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of an Inhaled Glucocorticosteroid (ICS) on Endothelial Dysfunction in Cigarette Smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068298', 'term': 'Fluticasone'}, {'id': 'D000073893', 'term': 'Sugars'}], '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'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'awanner@med.miami.edu', 'phone': '(305) 243-2568', 'title': 'Adam Wanner, MD', 'organization': 'University of Miami'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'The AEs were collected during the duration of the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Fluticasone', 'description': 'The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI). The subjects and the investigators will be blinded to the random choice of inhaler.\n\nFluticasone: 220 ug twice a day for 3 weeks\n\nPlacebo: Placebo for 3 weeks', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'The current smokers will be given a 3-week treatment course of inhaled placebo MDI. The subjects and the investigators will be blinded to the random choice of inhaler.\n\nFluticasone: 220 ug twice a day for 3 weeks\n\nPlacebo: Placebo for 3 weeks', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Albuterol Induced Change in Qaw Before and After Fluticasone or Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone', 'description': 'The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI). The subjects and the investigators will be blinded to the random choice of inhaler.\n\nFluticasone: 220 ug twice a day administered as a metered dose inhaled (MDI)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The current smokers will be given a 3-week treatment course of inhaled placebo MDI. The subjects and the investigators will be blinded to the random choice of inhaler.\n\nPlacebo: Placebo MDI'}], 'classes': [{'categories': [{'measurements': [{'value': '40.9', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '3.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks treatment period of ICS or placebo', 'description': 'Airway Blood flow (Qaw) will be measured before and 15 minutes after albuterol inhalation (delta Qaw).', 'unitOfMeasure': '% change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Flow-mediated Brachial Vasodilation (FMD% Peak Delta)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fluticasone', 'description': 'The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI). The subjects and the investigators will be blinded to the random choice of inhaler.\n\nFluticasone: 220 ug twice a day administered as a metered dose inhaled (MDI)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The current smokers will be given a 3-week treatment course of inhaled placebo MDI. The subjects and the investigators will be blinded to the random choice of inhaler.\n\nPlacebo: Placebo MDI'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks of treatment', 'description': 'Flow-mediated vasodilation response in the brachial artery will be measured before and 15 minutes.after albuterol inhalation', 'unitOfMeasure': '% change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fluticasone First, Then Placebo', 'description': 'The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI) or placebo. The subjects and the investigators will be blinded to the random choice of inhaler.\n\nFluticasone: 220 ug twice a day administered as a metered dose inhaled (MDI) or matching placebo'}, {'id': 'FG001', 'title': 'Placebo First, Then Fluticasone', 'description': 'The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI) or placebo. The subjects and the investigators will be blinded to the random choice of inhaler.\n\nFluticasone: 220 ug twice a day administered as a metered dose inhaled (MDI) or matching placebo'}], 'periods': [{'title': 'First Intervention (3 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout (3 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (3 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '17 Non-smokers were enrolled to provide baseline measures and did not receive any intervention or treatment'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Smokers', 'description': 'The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI). The subjects and the investigators will be blinded to the random choice of inhaler.\n\nFluticasone: 220 ug twice a day administered as a metered dose inhaled (MDI)'}, {'id': 'BG001', 'title': 'Non-smokers', 'description': 'this group served as controls for baseline data. No intervention or treatment were assigned to this group.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'age', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000', 'lowerLimit': '36', 'upperLimit': '58'}, {'value': '38', 'groupId': 'BG001', 'lowerLimit': '32', 'upperLimit': '54'}, {'value': '42', 'groupId': 'BG002', 'lowerLimit': '32', 'upperLimit': '58'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Airway blood flow (Qaw)', 'classes': [{'categories': [{'measurements': [{'value': '50.3', 'spread': '3.7', 'groupId': 'BG000'}, {'value': '46.2', 'spread': '3.5', 'groupId': 'BG001'}, {'value': '48.2', 'spread': '3.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'um/ml/ul', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': '32 participants were enrolled divided in two groups smokers and controls'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-27', 'studyFirstSubmitDate': '2010-10-06', 'resultsFirstSubmitDate': '2014-09-05', 'studyFirstSubmitQcDate': '2010-10-06', 'lastUpdatePostDateStruct': {'date': '2016-06-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-11-26', 'studyFirstPostDateStruct': {'date': '2010-10-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Albuterol Induced Change in Qaw Before and After Fluticasone or Placebo', 'timeFrame': '3 weeks treatment period of ICS or placebo', 'description': 'Airway Blood flow (Qaw) will be measured before and 15 minutes after albuterol inhalation (delta Qaw).'}], 'secondaryOutcomes': [{'measure': 'Flow-mediated Brachial Vasodilation (FMD% Peak Delta)', 'timeFrame': '3 weeks of treatment', 'description': 'Flow-mediated vasodilation response in the brachial artery will be measured before and 15 minutes.after albuterol inhalation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['smokers', 'inhaled corticosteroids', 'brachial flow', 'airway blood flow', 'albuterol', 'spirometry', 'endothelial dysfunction'], 'conditions': ['Tobacco Abuse Smoke']}, 'referencesModule': {'references': [{'pmid': '16608935', 'type': 'BACKGROUND', 'citation': 'Mendes ES, Campos MA, Wanner A. Airway blood flow reactivity in healthy smokers and in ex-smokers with or without COPD. Chest. 2006 Apr;129(4):893-8. doi: 10.1378/chest.129.4.893.'}, {'pmid': '18467553', 'type': 'BACKGROUND', 'citation': 'Mendes ES, Horvath G, Rebolledo P, Monzon ME, Casalino-Matsuda SM, Wanner A. Effect of an inhaled glucocorticoid on endothelial function in healthy smokers. J Appl Physiol (1985). 2008 Jul;105(1):54-7. doi: 10.1152/japplphysiol.90334.2008. Epub 2008 May 8.'}, {'pmid': '16414297', 'type': 'BACKGROUND', 'citation': 'Wanner A, Campos MA, Mendes E. Airway blood flow reactivity in smokers. Pulm Pharmacol Ther. 2007;20(2):126-9. doi: 10.1016/j.pupt.2005.12.004. Epub 2006 Jan 18.'}]}, 'descriptionModule': {'briefSummary': 'The hypothesis underlying the proposed study is that the blunted endothelium-dependent vasodilation seen in the airway of current smokers is also present in the brachial artery, and that the same inhaled corticosteroid (ICS) treatment regime that reversed endothelial function in the airway of current smokers will also restore endothelium-dependent relaxation in the brachial artery. Non-smokers will be used as controls and will not receive any intervention or treatment.', 'detailedDescription': 'Cigarette smoking can lead to systemic endothelial dysfunction. Since the airway circulation is exposed to a high concentration of cigarette smoke constituents, we reasoned that airway vascular endothelial dysfunction could be present in healthy smokers without systemic endothelial dysfunction.\n\nThe purpose of this study was to compare airway and systemic endothelial function and measure markers of systemic inflammation in lung-healthy current smokers. Since endothelial dysfunction in smokers has been related to systemic inflammation, we also investigated its response to an inhaled glucocorticosteroid (ICS).\n\nVascular endothelial function was assessed in the airway by the airway blood-flow (Qaw) response to inhaled albuterol (ΔQaw) and in the extrapulmonary circulation by brachial arterial flow-mediated vasodilation (FMD). Venous blood was collected for C-reactive protein and IL-6.\n\nQaw was measured with a noninvasive inhaled soluble gas uptake technique. The uptake of the gas from the anatomical deadspace reflecting airways perfused by the airway circulation was quantitated.\n\nQaw was express as μL/min normalized for anatomical deadspace: μL/min/mL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor both healthy non-smokers and healthy current smokers:\n\nnormal spirometry Healthy current smokers: history of \\>10 pack-year smoking\n\nExclusion Criteria:\n\nWomen of childbearing potential who do not use accepted birth control measures; pregnant and breast feeding women. Cardiovascular disease and/or use of cardiovascular medications. Subjects with known beta-adrenergic agonist or nitroglycerin intolerance. A physician diagnosis of chronic airway disease (asthma, COPD, bronchiectasis, cystic fibrosis).\n\nAcute respiratory infection within four weeks prior to the study. Use of any airway medication. FEV1 \\< 80% of predicted and FEV1/FVC \\< 0.7. A body mass index \\> 30.'}, 'identificationModule': {'nctId': 'NCT01216735', 'briefTitle': 'Effect of an Inhaled Glucocorticosteroid (ICS) on Endothelial Dysfunction in Cigarette Smokers', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Effect of an Inhaled Glucocorticosteroid (ICS) on Endothelial Dysfunction in Cigarette Smokers', 'orgStudyIdInfo': {'id': '20070896'}, 'secondaryIdInfos': [{'id': 'GSK 11340', 'type': 'OTHER', 'domain': 'Sponsor'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'smokers, Fluticasone first, then Placebo', 'description': 'The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI) . The subjects and the investigators will be blinded to the random choice of inhaler.', 'interventionNames': ['Drug: Fluticasone', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'smokers Placebo first, then Fluticasone', 'description': 'The current smokers will be given a 3-week treatment course of inhaled placebo MDI. The subjects and the investigators will be blinded to the random choice of inhaler.', 'interventionNames': ['Drug: Fluticasone', 'Drug: Placebo']}, {'type': 'NO_INTERVENTION', 'label': 'health non-smokers', 'description': 'The healthy non-smokers will have only visit 1 and no intervention.'}], 'interventions': [{'name': 'Fluticasone', 'type': 'DRUG', 'otherNames': ['flovent'], 'description': '220 ug twice a day for 3 weeks', 'armGroupLabels': ['smokers Placebo first, then Fluticasone', 'smokers, Fluticasone first, then Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['sugar pill'], 'description': 'Placebo for 3 weeks', 'armGroupLabels': ['smokers Placebo first, then Fluticasone', 'smokers, Fluticasone first, then Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Human Research Laboratory - University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Adam Wanner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Adam Wanner', 'investigatorAffiliation': 'University of Miami'}}}}