Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
Study NCT ID:
NCT04743206
Status:
TERMINATED
Last Update Posted:
2024-11-19
First Post:
2021-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Airway Clearance for Pediatric and Adult Cystic Fibrosis Patients Using a Portable Intra-Pulmonary Percussion Device
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}}}}, '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': 'silviadelgado@ufl.edu', 'phone': '7185684198', 'title': 'Silvia Delgado Villalta', 'organization': 'University of Florida'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'The collection time was between June 17, 2021 to June 26, 2021 - please clarify this is a 4 week study', 'description': 'NO Adverse events reported', 'eventGroups': [{'id': 'EG000', 'title': 'Vest Followed by PIADD', 'description': 'Vest airway clearance treatment for 2 weeks, followed by PIADD airway clearance treatment for 2 weeks', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Oxygen Saturation % by Pulse Oximetry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SOC Airway Clearance Device (VEST) Followed by PIAPD-Portable Internal Airway Percussion Device', 'description': 'Subjects will use Standard of Care (SCA) airway clearance Device (VEST) for 2 weeks followed by Interventional Airway Clearance Device (PIAPD) for 2 weeks.'}], 'classes': [{'title': 'week 1 Vest pretreatment', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}]}]}, {'title': 'week 1 Vest post treatment', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}]}]}, {'title': 'week 2 Vest pretreatment', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}]}]}, {'title': 'week 2 Vest post treatment', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}]}]}, {'title': 'week 1 PIAPD pretreatment', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}]}]}, {'title': 'week 1 PIAPD post treatment', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}]}]}, {'title': 'week 2 PIAPD pretreatment', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}]}]}, {'title': 'week 2 PIAPD post treatment', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'O2 saturation measured immediately prior to treatment and 2 hours after treatment - one-time pre/post treatment in week 1; and one-time pre/post treatment in week 2', 'description': 'oxygen saturation will be obtained by home pulse oximeter device.', 'unitOfMeasure': 'percentage of oxygen saturated hemoglobi', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SOC Airway Clearance Device (VEST) Followed by PIAPD-Portable Internal Airway Percussion Device', 'description': 'Subjects will use Standard of Care (SCA) airway clearance Device (VEST) for 2 weeks followed by Interventional Airway Clearance Device (PIAPD) for 2 weeks.\n\nForced Expiratory Volume in 1 Second (FEV1) will be measured by Smart One® portable home spirometer.'}], 'periods': [{'title': 'SOC Airway Clearance Device ( VEST)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'PIAPD', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Only one patient was recruited to the study. The patient was outpatient. There were difficulties with recruitment related to COVID-19 pandemic, difficulties obtaining pulmonary function testing related to Covid-19 pandemic, limited staff.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'SACD-Standard Airway Clearance Device Followed by PIAPD', 'description': 'There will be an Outpatient Arm using the SACD for 2 weeks followed by PIAPD for 2 weeks.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'only one patient was recruited. The patient participated as outpatient.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-09', 'size': 300479, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-28T13:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This is a pilot study where the investigators aim to compare initial use of the standard airway clearance device (SACD) with subsequent use of a PIAPD in patients with stable cystic fibrosis ages 6 -21 years. The primary hypothesis (Stated as Null) being that there is no effect of PIAPD on FEV1 2 hours after use, there is no effect on perception of effort and efficacy for the PIAPD.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'recruitment difficulty due to COVID recruitment difficulty due to covid', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-28', 'studyFirstSubmitDate': '2021-02-03', 'resultsFirstSubmitDate': '2024-10-03', 'studyFirstSubmitQcDate': '2021-02-05', 'lastUpdatePostDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-28', 'studyFirstPostDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxygen Saturation % by Pulse Oximetry', 'timeFrame': 'O2 saturation measured immediately prior to treatment and 2 hours after treatment - one-time pre/post treatment in week 1; and one-time pre/post treatment in week 2', 'description': 'oxygen saturation will be obtained by home pulse oximeter device.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Airway Clearance'], 'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'This is a pilot study where the investigators aim to compare initial use of the standard airway clearance device (SACD), most commonly used being High frequency vest airway clearance system (VEST) with subsequent use of a Portable Intra-Pulmonary Percussion Device (PIAPD) in patients with cystic fibrosis (CF) ages 6 -21 years. The primary hypothesis is that there is no effect of PIAPD on Forced expiratory volume in 1 second (FEV1) 2 hours after use, there is no effect on perception of effort and efficacy for the PIAPD. If both are equally effective, the latter device provides an alternative that is both cheaper and portable.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 6-21 years\n* Cystic fibrosis stable by physician assessment\n* Assents to forego additional experimental treatments during the study\n* Currently using and familiar with airway clearance therapy for treatment of cystic fibrosis\n* Participant (or parent or legal guardian if the participant is a minor) is willing to provide -----Informed Consent\n\nExclusion Criteria:\n\n* FEV1 \\< 40% predictive\n* Pneumothorax\n* Hemoptysis\n* Coronavirus disease (COVID) 19 diagnosis within last 14 days\n* Any condition that, in the opinion of the investigator, would interfere with the study conduct or the safety of the participant\n\n * Additional Exclusion Criteria: Outpatient Arm (in addition to general exclusion criteria above) Decrease in FEV1 \\> 10% from baseline over last 12 months Antibiotic Initiation for acute CF exacerbation Hospitalization for CF Exacerbation\n * Additional Exclusion Criteria: Inpatient Arm (in addition to general exclusion criteria above) Failure to increase FEV1 \\> 10 % from initial Pulmonary function testing (PFTs) on admission by day 9 of hospitalization.'}, 'identificationModule': {'nctId': 'NCT04743206', 'briefTitle': 'Airway Clearance for Pediatric and Adult Cystic Fibrosis Patients Using a Portable Intra-Pulmonary Percussion Device', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Airway Clearance for Pediatric and Adult Cystic Fibrosis Patients Using a Portable Intra-Pulmonary Percussion Device (PIAPD)', 'orgStudyIdInfo': {'id': 'IRB201902662'}, 'secondaryIdInfos': [{'id': 'OCR39724', 'type': 'OTHER', 'domain': 'UF Oncore'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PIAPD-Portable Internal Airway Percussion device', 'description': 'There will be an outpatient arm using the PIAPD-Portable Internal Airway Percussion Device.', 'interventionNames': ['Device: Portable Internal Airway Percussion device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SACD-Standard Airway Clearance device', 'description': 'There will be an Outpatient Arm using the SACD, VEST (High Frequency Chest Wall Oscillation VEST) Standard Airway Clearance Device.', 'interventionNames': ['Device: Standard Airway Clearance device']}], 'interventions': [{'name': 'Standard Airway Clearance device', 'type': 'DEVICE', 'description': 'Subjects will be using their home standard airway clearance device, VEST (High Frequency Chest Wall Oscillation VEST) for 2 weeks followed by PIAPD.', 'armGroupLabels': ['SACD-Standard Airway Clearance device']}, {'name': 'Portable Internal Airway Percussion device', 'type': 'DEVICE', 'description': 'Subjects will be using the investigational device, PIAPD (Portable Internal Airway Percussion Device) for 2 weeks.', 'armGroupLabels': ['PIAPD-Portable Internal Airway Percussion device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'UF Medical Plaza Pulmonary Clinic', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Silvia Delgado Villalta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}