Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-03 @ 9:02 AM
Study NCT ID:
NCT03270332
Status:
COMPLETED
Last Update Posted:
2021-08-30
First Post:
2017-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Inhaled Albuterol in Pulmonary Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000420', 'term': 'Albuterol'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'awanner@miami.edu', 'phone': '3053010563', 'title': 'Dr. Adam Wanner', 'organization': 'University of Miami'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 day', 'eventGroups': [{'id': 'EG000', 'title': 'Albuterol Group', 'description': 'This is a cross-over study. All participants received albuterol.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Group', 'description': 'This is a cross-over study. All participants received placebo.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Mean Pulmonary Artery Pressure (MPAP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albuterol Group', 'description': 'This is a cross-over study design. All participants received albuterol'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'This is a cross-over design. All participants received placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '3.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, up to 30 minutes after inhalation', 'description': 'Change in MPAP will be measured using echocardiogram', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'This is a cross-over study design. All enrolled participants received both the albuterol and placebo intervention.'}, {'type': 'SECONDARY', 'title': 'Change in Pulmonary Vascular Resistance (PVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albuterol Group', 'description': 'This is a cross-over study. All participants received albuterol.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'This is a cross-over study. All participants received placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '217', 'spread': '92', 'groupId': 'OG000'}, {'value': '108', 'spread': '153', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, up to 30 minutes after inhalation', 'description': 'Change in PVR will be measured using echocardiogram', 'unitOfMeasure': 'dyn.s.cm-5', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'This is a cross-over study design. All enrolled participants received both the albuterol and placebo intervention.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Albuterol Followed by Placebo', 'description': 'Participants in this group will receive albuterol first followed by Placebo on the next visit\n\nAlbuterol: inhalation of 270μg albuterol through a spacer\n\nPlacebo: inhalation of placebo through a spacer'}, {'id': 'FG001', 'title': 'Placebo Followed by Albuterol', 'description': 'Participants in this group will receive placebo first followed by albuterol on the next visit\n\nAlbuterol: inhalation of 270μg albuterol through a spacer\n\nPlacebo: inhalation of placebo through a spacer'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Albuterol Followed by Placebo', 'description': 'Participants in this group will receive albuterol first followed by Placebo on the next visit\n\nAlbuterol: inhalation of 270μg albuterol through a spacer\n\nPlacebo: inhalation of placebo through a spacer'}, {'id': 'BG001', 'title': 'Placebo Followed by Albuterol', 'description': 'Participants in this group will receive placebo first followed by albuterol on the next visit\n\nAlbuterol: inhalation of 270μg albuterol through a spacer\n\nPlacebo: inhalation of placebo through a spacer'}, {'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': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', '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': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-04', 'size': 208717, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-08-04T15:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-04', 'studyFirstSubmitDate': '2017-08-30', 'resultsFirstSubmitDate': '2021-08-04', 'studyFirstSubmitQcDate': '2017-08-30', 'lastUpdatePostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-04', 'studyFirstPostDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Mean Pulmonary Artery Pressure (MPAP)', 'timeFrame': 'Baseline, up to 30 minutes after inhalation', 'description': 'Change in MPAP will be measured using echocardiogram'}], 'secondaryOutcomes': [{'measure': 'Change in Pulmonary Vascular Resistance (PVR)', 'timeFrame': 'Baseline, up to 30 minutes after inhalation', 'description': 'Change in PVR will be measured using echocardiogram'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of the present pilot study is to test the hypothesis that in patients with group 1 pulmonary arterial hypertension (PAH) who are on regular oral pulmonary vasodilator therapy, inhaled albuterol causes transient pulmonary vasodilation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A Mean Pulmonary Artery Pressure \\>25mmHg, Pulmonary Vascular Resistance \\>3 wood/units and pulmonary arterial wedge pressure \\<15mmHg, as documented by right heart catheterization within the last 3 years\n* Regular use of oral pulmonary vasodilators\n\nExclusion Criteria:\n\n* Presence of chronic respiratory disease (as documented by prior lung imaging and pulmonary function tests), cardiovascular disease (as documented by prior echocardiography and/or left heart catheterization), thromboembolic PAH (as documented by pulmonary angiography)\n* women of childbearing potential who do not use accepted birth- control measures\n* pregnant and breast-feeding women\n* respiratory infection within 4 weeks of testing\n* A systemic systolic arterial BP\\> 150 and/or diastolic arterial BP\\>100 on the experiment day\n* A resting O2 saturation of \\< 90%\n* Current smoking\n* BMI \\>35 kg/m2 and/or a diagnosis of obstructive sleep apnea\n* Use of inhaled or intravenous pulmonary vasodilators'}, 'identificationModule': {'nctId': 'NCT03270332', 'briefTitle': 'Effect of Inhaled Albuterol in Pulmonary Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Effect of Inhaled Albuterol on Pulmonary Hemodynamics in Patients With Group 1 Pulmonary Arterial Hypertension on Oral Pulmonary Vasodilator Therapy: A Proof of Concept Study', 'orgStudyIdInfo': {'id': '20170552'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Albuterol followed by placebo', 'description': 'Participants in this group will receive albuterol first followed by Placebo on the next visit', 'interventionNames': ['Drug: Albuterol', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo followed by albuterol', 'description': 'Participants in this group will receive placebo first followed by albuterol on the next visit', 'interventionNames': ['Drug: Albuterol', 'Drug: Placebo']}], 'interventions': [{'name': 'Albuterol', 'type': 'DRUG', 'description': 'inhalation of 270μg albuterol through a spacer', 'armGroupLabels': ['Albuterol followed by placebo', 'Placebo followed by albuterol']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'inhalation of placebo through a spacer', 'armGroupLabels': ['Albuterol followed by placebo', 'Placebo followed by albuterol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Adam Wanner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Adam Wanner', 'investigatorAffiliation': 'University of Miami'}}}}