Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-03-06 @ 5:46 AM
Study NCT ID:
NCT02141633
Status:
COMPLETED
Last Update Posted:
2016-12-16
First Post:
2014-03-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Airway and Pulmonary Vascular Endothelial Function in Healthy Smokers: Effect of Inhaled Glucocorticosteroid Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000420', 'term': 'Albuterol'}, {'id': 'D000068298', 'term': 'Fluticasone'}], 'ancestors': [{'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': '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': {'email': 'awanner@med.miami.edu', 'phone': '(305) 243-3045', 'title': 'Dr Adam Wanner Professor of Medicine Division of Pulmonary and Critical Care Medicine', 'organization': 'University of Miami'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '2 years and 10 month', 'eventGroups': [{'id': 'EG000', 'title': 'Smokers', 'description': 'No AE or SAE had occurred', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non-smokers', 'description': 'No AE or SAE had occurred', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Airway Blood Flow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Smokers', 'description': 'participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol.\n\nechocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol\n\nairway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol'}, {'id': 'OG001', 'title': 'Non-smokers', 'description': 'participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol\n\nechocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol\n\nairway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol'}], 'classes': [{'categories': [{'measurements': [{'value': '2.13', 'spread': '2.52', 'groupId': 'OG000'}, {'value': '13.05', 'spread': '1.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'before and 15 minutes after albuterol inhalation', 'description': 'compare inhaled albuterol-induced changes in airway blood flow (ΔQaw) in healthy current smokers and lifetime non-smokers as an index of endothelial function in the airway circulation and to compare the results between smokers and non-smokers', 'unitOfMeasure': 'ΔQaw (ul/min/ml)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Echocardiogram', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Smokers', 'description': 'participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol.\n\nechocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol\n\nairway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol'}, {'id': 'OG001', 'title': 'Non-smokers', 'description': 'participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol\n\nechocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol\n\nairway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.70', 'spread': '1.37', 'groupId': 'OG000'}, {'value': '-9.04', 'spread': '0.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'MPAP before and 15 minutes after albuterol inhalation in smokers vs non-smokers', 'description': 'to compare inhaled albuterol-induced changes in echocardiogram measuring mean pulmonary artery pressure (MPAP)in healthy current smokers and lifetime non-smokers as an index of endothelial function in the pulmonary circulation and to compare the results between smokers and non-smokers', 'unitOfMeasure': 'ΔMPAP (mmHg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Smokers', 'description': 'participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol.\n\nechocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol\n\nairway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol'}, {'id': 'FG001', 'title': 'Non-smokers', 'description': 'participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol\n\nechocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol\n\nairway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Smokers', 'description': 'echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol\n\nairway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol'}, {'id': 'BG001', 'title': 'Non-smokers', 'description': 'echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol\n\nairway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'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': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', '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': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.6', 'spread': '2.0', 'groupId': 'BG000'}, {'value': '44.7', 'spread': '2.0', 'groupId': 'BG001'}, {'value': '46.2', 'spread': '2.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-25', 'studyFirstSubmitDate': '2014-03-25', 'resultsFirstSubmitDate': '2016-07-07', 'studyFirstSubmitQcDate': '2014-05-16', 'lastUpdatePostDateStruct': {'date': '2016-12-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-10-25', 'studyFirstPostDateStruct': {'date': '2014-05-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Airway Blood Flow', 'timeFrame': 'before and 15 minutes after albuterol inhalation', 'description': 'compare inhaled albuterol-induced changes in airway blood flow (ΔQaw) in healthy current smokers and lifetime non-smokers as an index of endothelial function in the airway circulation and to compare the results between smokers and non-smokers'}], 'secondaryOutcomes': [{'measure': 'Echocardiogram', 'timeFrame': 'MPAP before and 15 minutes after albuterol inhalation in smokers vs non-smokers', 'description': 'to compare inhaled albuterol-induced changes in echocardiogram measuring mean pulmonary artery pressure (MPAP)in healthy current smokers and lifetime non-smokers as an index of endothelial function in the pulmonary circulation and to compare the results between smokers and non-smokers'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['smokers', 'airway blood flow', 'fluticasone', 'echocardiogram'], 'conditions': ['Smoking']}, 'descriptionModule': {'briefSummary': 'The purposes of the present proposal are to 1) compare inhaled albuterol-induced changes in airway blood flow (Qaw), and in CO and Ppas in healthy current smokers and lifetime non-smokers as an index of endothelial function in the airway and pulmonary circulations, 2) compare the results between smokers and non-smokers, and 3) determine the effect of a 4-week treatment with an ICS on albuterol responsiveness of Qaw and the echocardiographic parameters. With this protocol the Investigators will test the hypotheses that a) there is a correlation between airway and pulmonary vascular endothelial function within the current smoker and non-smoker groups, and b) ICS treatment improves airway and pulmonary vascular endothelial function in the current smoker group.', 'detailedDescription': 'With this protocol the Investigators will test the hypotheses that a) there is a correlation between airway and pulmonary vascular endothelial function within the current smoker and non-smoker groups, and b) ICS treatment improves airway and pulmonary vascular endothelial function in the current smoker group.\n\nFifteen healthy current smokers with a \\>10 pack-year history of smoking and 15 healthy never-smokers will be enrolled. Males and females between 25 and 75 years of age will be recruited There will be 1-4 visits to the laboratory (one for non-smokers, 4 for smokers). All subjects will have the first visit. Current smokers will have 3 additional visits. Current smokers will be asked not to smoke before coming to the laboratory on the 3 study days. All subjects will be instructed to abstain from ingesting alcoholic beverages, coffee or caffeinated drinks for at least 12 hours the night before each study day. The subjects will also be instructed not to use PDE5 inhibitors for 24 hours before coming to the laboratory. On each study day, the protocol will start at the same time (in the morning).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fifteen healthy current smokers with a \\>10 pack-year history of smoking and 15 healthy never-smokers will be enrolled. Males and females between 25 and 75 years of age will be recruited.\n\nExclusion Criteria:\n\n* Women of childbearing potential who do not use accepted birth control measures; pregnant and breast feeding women\n* Cardiovascular disease and/or use of cardiovascular medications\n* Subjects with known beta-adrenergic agonist intolerance\n* A physician diagnosis of chronic airway disease (asthma, COPD, bronchiectasis, cystic fibrosis)\n* Acute respiratory infection within four weeks prior to the study\n* Use of any airway medication\n* Abnormal pulmonary function'}, 'identificationModule': {'nctId': 'NCT02141633', 'acronym': 'smoker3', 'briefTitle': 'Airway and Pulmonary Vascular Endothelial Function in Healthy Smokers: Effect of Inhaled Glucocorticosteroid Treatment', 'nctIdAliases': ['NCT02026375'], 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Airway and Pulmonary Vascular Endothelial Function in Healthy Smokers: Effect of Inhaled Glucocorticosteroid Treatment', 'orgStudyIdInfo': {'id': '20120896'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'smokers', 'description': 'participants with smoking history ( \\> 10 pack/year) will be enrolled and perform airway blood flow and echocardiogram before and 15 minutes after albuterol inhalation', 'interventionNames': ['Procedure: echocardiogram plus albuterol', 'Procedure: airway blood flow plus albuterol', 'Drug: Fluticasone propionate', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'non-smokers', 'description': 'healthy life-time non smokers will be enrolled and perform airway blood flow and echocardiogram before and 15 minutes after albuterol inhalation', 'interventionNames': ['Procedure: echocardiogram plus albuterol', 'Procedure: airway blood flow plus albuterol']}], 'interventions': [{'name': 'echocardiogram plus albuterol', 'type': 'PROCEDURE', 'description': 'participants will performed echocardiogram before and 15 minutes after inhaled albuterol', 'armGroupLabels': ['non-smokers', 'smokers']}, {'name': 'airway blood flow plus albuterol', 'type': 'PROCEDURE', 'otherNames': ['Qaw'], 'description': 'participants will performed echocardiogram before and 15 minutes after inhaled albuterol', 'armGroupLabels': ['non-smokers', 'smokers']}, {'name': 'Fluticasone propionate', 'type': 'DRUG', 'description': 'participant will be received a 4-week course of inhaled fluticasone (220 μg fluticasone twice a day administered as a MDI using a spacer)', 'armGroupLabels': ['smokers']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'participant will be received a 4-week course of identically appearing placebo (2 puffs twice a day via spacer).', 'armGroupLabels': ['smokers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami School of Medicine', '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'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Professor', 'investigatorFullName': 'Adam Wanner', 'investigatorAffiliation': 'University of Miami'}}}}