Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-30 @ 2:54 AM
Study NCT ID:
NCT02129803
Status:
COMPLETED
Last Update Posted:
2021-01-06
First Post:
2014-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluating High Flow Humidification Therapy in Patients With Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bruce.rubin@vcuhealth.org', 'phone': '804 828 9604', 'title': 'Bruce K. Rubin MEngr, MD, MBA, FRCPC', 'organization': 'Virginia Commonwealth University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Length of hospital stay - up to 3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental Therapy', 'description': 'High-Flow, 20 LPM (via Optiflow cannula) Heated (34C) Humidified Air\n\nHigh-Flow, 20 LPM (via Optiflow cannula): Nasal high flow humidification (20LPM) therapy will be administered using Optiflow with Airvo 2.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Therapy (Low Flow)', 'description': 'Low FLow, 5 LPM (via Optiflow cannula) Room Temperature (23-26C) Ambient Air\n\nLow FLow, 5 LPM (via Optiflow cannula): standard humidified wall medical air.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 1, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Therapy', 'description': 'High-Flow, 20 LPM (via Optiflow cannula) Heated (34C) Humidified Air\n\nHigh-Flow, 20 LPM (via Optiflow cannula): Nasal high flow humidification (20LPM) therapy will be administered using Optiflow with Airvo 2.'}, {'id': 'OG001', 'title': 'Control Therapy (Low Flow)', 'description': 'Low FLow, 5 LPM (via Optiflow cannula) Room Temperature (23-26C) Ambient Air\n\nLow FLow, 5 LPM (via Optiflow cannula): standard humidified wall medical air.'}], 'classes': [{'title': 'Physical functioning subscale', 'categories': [{'measurements': [{'value': '0.056', 'spread': '0.105', 'groupId': 'OG000'}, {'value': '0.052', 'spread': '0.152', 'groupId': 'OG001'}]}]}, {'title': 'Vitality subscale', 'categories': [{'measurements': [{'value': '0.192', 'spread': '0.139', 'groupId': 'OG000'}, {'value': '0.194', 'spread': '0.115', 'groupId': 'OG001'}]}]}, {'title': 'Emotional state subscale', 'categories': [{'measurements': [{'value': '-0.089', 'spread': '0.139', 'groupId': 'OG000'}, {'value': '0.033', 'spread': '0.087', 'groupId': 'OG001'}]}]}, {'title': 'Social limitations subscale', 'categories': [{'measurements': [{'value': '-0.056', 'spread': '0.096', 'groupId': 'OG000'}, {'value': '-0.028', 'spread': '0.154', 'groupId': 'OG001'}]}]}, {'title': 'Role limitations subscale', 'categories': [{'measurements': [{'value': '-0.056', 'spread': '0.192', 'groupId': 'OG000'}, {'value': '0.010', 'spread': '0.175', 'groupId': 'OG001'}]}]}, {'title': 'Body image subscale', 'categories': [{'measurements': [{'value': '0.037', 'spread': '0.170', 'groupId': 'OG000'}, {'value': '0.125', 'spread': '0.192', 'groupId': 'OG001'}]}]}, {'title': 'Eating disturbances subscale', 'categories': [{'measurements': [{'value': '0.037', 'spread': '0.280', 'groupId': 'OG000'}, {'value': '0.097', 'spread': '0.162', 'groupId': 'OG001'}]}]}, {'title': 'Treatment constraints subscale', 'categories': [{'measurements': [{'value': '-0.037', 'spread': '0.170', 'groupId': 'OG000'}, {'value': '-0.097', 'spread': '0.093', 'groupId': 'OG001'}]}]}, {'title': 'Respiratory symptoms subscale', 'categories': [{'measurements': [{'value': '0.019', 'spread': '0.170', 'groupId': 'OG000'}, {'value': '-0.125', 'spread': '0.856', 'groupId': 'OG001'}]}]}, {'title': 'Digestive symptoms subscale', 'categories': [{'measurements': [{'value': '0.111', 'spread': '0.192', 'groupId': 'OG000'}, {'value': '0.028', 'spread': '0.098', 'groupId': 'OG001'}]}]}, {'title': 'Weight subscale', 'categories': [{'measurements': [{'value': '-0.222', 'spread': '0.192', 'groupId': 'OG000'}, {'value': '0.083', 'spread': '0.236', 'groupId': 'OG001'}]}]}, {'title': 'Health status subscale', 'categories': [{'measurements': [{'value': '-0.083', 'spread': '0.399', 'groupId': 'OG000'}, {'value': '0.000', 'spread': '0.103', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 to Day 6 or upon discharge from the hospital, whichever comes first', 'description': 'The Cystic Fibrosis Questionnaire-Revised (CFQ-R) is a validated health-related quality of life measure for CF that meets US Food and Drug Administration psychometric requirements for patient reported outcomes. It contains both generic and CF-specific scales and has demonstrated responsiveness in previous clinical studies. Scores range from 0 to 100 with higher scores indicating better health.', 'unitOfMeasure': 'change in score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Results could not be reported for 4 participants due to missing baseline data in one case, missing followup data in one case, and no CFQ-R data in two cases.'}, {'type': 'SECONDARY', 'title': 'Sputum Collection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Therapy', 'description': 'High-Flow, 20 LPM (via Optiflow cannula) Heated (34C) Humidified Air\n\nHigh-Flow, 20 LPM (via Optiflow cannula): Nasal high flow humidification (20LPM) therapy will be administered using Optiflow with Airvo 2.'}, {'id': 'OG001', 'title': 'Control Therapy (Low Flow)', 'description': 'Low FLow, 5 LPM (via Optiflow cannula) Room Temperature (23-26C) Ambient Air\n\nLow FLow, 5 LPM (via Optiflow cannula): standard humidified wall medical air.'}], 'timeFrame': '10 minutes', 'description': 'Sputum is collected during pulmonary function test (PFT) to later measure the biophysical properties of cystic fibrosis sputum.', 'reportingStatus': 'POSTED', 'populationDescription': 'We were unable to collect sputum samples from the participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental Therapy', 'description': 'High-Flow, 20 LPM (via Optiflow cannula) Heated (34C) Humidified Air\n\nHigh-Flow, 20 LPM (via Optiflow cannula): Nasal high flow humidification (20LPM) therapy will be administered using Optiflow with Airvo 2.'}, {'id': 'FG001', 'title': 'Control Therapy (Low Flow)', 'description': 'Low FLow, 5 LPM (via Optiflow cannula) Room Temperature (23-26C) Ambient Air\n\nLow FLow, 5 LPM (via Optiflow cannula): standard humidified wall medical air.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Difficulty sleeping', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Morning headache', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental Therapy', 'description': 'High-Flow, 20 LPM (via Optiflow cannula) Heated (34C) Humidified Air\n\nHigh-Flow, 20 LPM (via Optiflow cannula): Nasal high flow humidification (20LPM) therapy will be administered using Optiflow with Airvo 2.'}, {'id': 'BG001', 'title': 'Control Therapy (Low Flow)', 'description': 'Low FLow, 5 LPM (via Optiflow cannula) Room Temperature (23-26C) Ambient Air\n\nLow FLow, 5 LPM (via Optiflow cannula): standard humidified wall medical air.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '19.4', 'spread': '5.4', 'groupId': 'BG000'}, {'value': '21.7', 'spread': '6.7', 'groupId': 'BG001'}, {'value': '20.5', 'spread': '6.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', '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'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', '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': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', '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'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-05-25', 'size': 386738, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-11-20T11:22', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'dispFirstSubmitDate': '2020-04-28', 'completionDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-04', 'studyFirstSubmitDate': '2014-04-10', 'dispFirstSubmitQcDate': '2020-05-01', 'resultsFirstSubmitDate': '2020-11-30', 'studyFirstSubmitQcDate': '2014-05-01', 'dispFirstPostDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-04', 'studyFirstPostDateStruct': {'date': '2014-05-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R)', 'timeFrame': 'Day 0 to Day 6 or upon discharge from the hospital, whichever comes first', 'description': 'The Cystic Fibrosis Questionnaire-Revised (CFQ-R) is a validated health-related quality of life measure for CF that meets US Food and Drug Administration psychometric requirements for patient reported outcomes. It contains both generic and CF-specific scales and has demonstrated responsiveness in previous clinical studies. Scores range from 0 to 100 with higher scores indicating better health.'}], 'secondaryOutcomes': [{'measure': 'Sputum Collection', 'timeFrame': '10 minutes', 'description': 'Sputum is collected during pulmonary function test (PFT) to later measure the biophysical properties of cystic fibrosis sputum.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Cystic Fibrosis, high flow 20 liters per minute (LPM) humidification therapy'], 'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'This study is a single center, randomized pilot study to evaluate the clinical effectiveness of nasal high flow 20LPM humidification therapy in subjects with Cystic Fibrosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of CF\n* Hospital admission for acute pulmonary exacerbation of CF (using Fuchs criteria 4/10)\n* 10 years of age and older\n* Subject is able to comply with the procedures scheduled in the protocol\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Receipt of any aerosolized experimental or investigational drugs within 1 month of enrollment\n* Subject had ear, nose, and throat (ENT) surgery, nasal bleeding, or nasal polyps within 6 months prior to study\n* Subject is unlikely to comply with the procedures scheduled in the protocol\n* Inability to give informed consent\n* Subject requires supplemental oxygen\n* History of obstructive sleep apnea\n* History of pressure headaches requiring therapy within one month of enrollment\n* Any other medical or psychological condition in which the study doctor(s) believe(s) would inhibit the individual from being an appropriate study subject.'}, 'identificationModule': {'nctId': 'NCT02129803', 'briefTitle': 'Evaluating High Flow Humidification Therapy in Patients With Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Evaluating High Flow Humidification Therapy in Patients With Cystic Fibrosis', 'orgStudyIdInfo': {'id': 'HM20002205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Therapy', 'description': 'High-Flow, 20 LPM (via Optiflow cannula) Heated (34C) Humidified Air', 'interventionNames': ['Device: High-Flow, 20 LPM (via Optiflow cannula)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Therapy (Low Flow)', 'description': 'Low FLow, 5 LPM (via Optiflow cannula) Room Temperature (23-26C) Ambient Air', 'interventionNames': ['Device: Low FLow, 5 LPM (via Optiflow cannula)']}], 'interventions': [{'name': 'High-Flow, 20 LPM (via Optiflow cannula)', 'type': 'DEVICE', 'description': 'Nasal high flow humidification (20LPM) therapy will be administered using Optiflow with Airvo 2.', 'armGroupLabels': ['Experimental Therapy']}, {'name': 'Low FLow, 5 LPM (via Optiflow cannula)', 'type': 'DEVICE', 'description': 'standard humidified wall medical air.', 'armGroupLabels': ['Control Therapy (Low Flow)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': "Children's Hospital of Richmond at VCU", 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Bruce K Rubin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}