Ignite Creation Date:
2025-12-24 @ 5:52 PM
Ignite Modification Date:
2026-01-01 @ 8:56 AM
Study NCT ID:
NCT01303068
Status:
COMPLETED
Last Update Posted:
2024-01-30
First Post:
2011-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Detection of Pseudomonas Aeruginosa in the Airways of Patients With CF
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': 'hraissy@salud.unm.edu', 'phone': '5052725484', 'title': 'Hengameh Raissy', 'organization': 'University of New Mexico'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'CF Patients, 13C Urea Breath Test Kit', 'description': 'CF patients with Pseudomonas infection tested with 13C urea breath test\n\n13C urea breath test Kit: 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Healthy Subjects Using 13C Urea Breath Test Kit', 'description': 'Healthy subjects using 13C urea breath test kit\n\n13C urea breath test Kit: 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Primary Objective is to Assess the Safety of 13C Urea Administered by Inhalation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CF Patients, 13C Urea Breath Test Kit', 'description': 'CF patients with Pseudomonas infection tested with 13C urea breath test\n\n13C urea breath test Kit: 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas'}, {'id': 'OG001', 'title': 'Healthy Subjects Using 13C Urea Breath Test Kit', 'description': 'Healthy subjects using 13C urea breath test kit\n\n13C urea breath test Kit: 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 hours', 'description': 'The primary endpoint is the safety of inhaled 13C urea assessed by adverse events including pulmonary findings and changes from baseline in physical examination findings, pulse oximetry results, pulmonary function test results, and vital signs.', 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Secondary Objective is to Assess the Kinetics of 13C Carbon Dioxide Production by Measuring the Isotopic Ratio of 13C to 12C in Exhaled Carbon Dioxide.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CF Patients, 13C Urea Breath Test Kit', 'description': 'CF patients with Pseudomonas infection tested with 13C urea breath test\n\n13C urea breath test Kit: 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas'}, {'id': 'OG001', 'title': 'Healthy Subjects Using 13C Urea Breath Test Kit', 'description': 'Healthy subjects using 13C urea breath test kit\n\n13C urea breath test Kit: 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas'}], 'classes': [{'title': '20 mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '4.9'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '1.2'}]}]}, {'title': '50 mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '6.2', 'upperLimit': '14.5'}, {'value': '2.13', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '5.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 minutes post inhalation', 'description': 'Secondary endpoints are the isotopic ratios of 13C to 12C in exhaled carbon dioxide measured with the POCone detector (Meretek Diagnostics Group of Otsuka America Pharmaceutical, Rockville, MD) at 5, 10, and 15 minutes after study drug administration.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'CF patients with infection has a higher 13C urea in their exhaled breath.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CF Patients, 13C Urea Breath Test Kit', 'description': 'CF patients with Pseudomonas infection tested with 13C urea breath test\n\n13C urea breath test Kit: 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas'}, {'id': 'FG001', 'title': 'Healthy Subjects Using 13C Urea Breath Test Kit', 'description': 'Healthy subjects using 13C urea breath test kit\n\n13C urea breath test Kit: 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CF Patients, 13C Urea Breath Test Kit', 'description': 'CF patients with Pseudomonas infection tested with 13C urea breath test\n\n13C urea breath test Kit: 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas'}, {'id': 'BG001', 'title': 'Healthy Controls, 13C Urea Breath Test Kit', 'description': 'Healthy subjects using 13C urea breath test kit\n\n13C urea breath test Kit: 20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '31'}, {'value': '32', 'groupId': 'BG001', 'lowerLimit': '24', 'upperLimit': '41'}, {'value': '29', 'groupId': 'BG002', 'lowerLimit': '23', 'upperLimit': '41'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2012-11-29', 'size': 590631, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-01-26T11:25', 'hasProtocol': True}, {'date': '2012-11-29', 'size': 139232, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-01-26T11:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'dispFirstSubmitDate': '2015-12-10', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-26', 'studyFirstSubmitDate': '2011-02-14', 'dispFirstSubmitQcDate': '2015-12-10', 'resultsFirstSubmitDate': '2020-12-15', 'studyFirstSubmitQcDate': '2011-02-23', 'dispFirstPostDateStruct': {'date': '2016-01-13', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-23', 'studyFirstPostDateStruct': {'date': '2011-02-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Primary Objective is to Assess the Safety of 13C Urea Administered by Inhalation.', 'timeFrame': '6 hours', 'description': 'The primary endpoint is the safety of inhaled 13C urea assessed by adverse events including pulmonary findings and changes from baseline in physical examination findings, pulse oximetry results, pulmonary function test results, and vital signs.'}], 'secondaryOutcomes': [{'measure': 'The Secondary Objective is to Assess the Kinetics of 13C Carbon Dioxide Production by Measuring the Isotopic Ratio of 13C to 12C in Exhaled Carbon Dioxide.', 'timeFrame': '5 minutes post inhalation', 'description': 'Secondary endpoints are the isotopic ratios of 13C to 12C in exhaled carbon dioxide measured with the POCone detector (Meretek Diagnostics Group of Otsuka America Pharmaceutical, Rockville, MD) at 5, 10, and 15 minutes after study drug administration.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CF'], 'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if inhaled urea can be used to detect the presence of Pseudomonas Aeruginosa in the lungs', 'detailedDescription': 'Dose Escalation study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with CF aged 18 years and above colonized with P. aeruginosa\n* Normal subjects ages 18 and above without CF or p. aeruginosa\n\nExclusion Criteria:\n\n* for patients and volunteers will include the presence of asthma, allergic rhinitis, pregnancy, a history of gastric or duodenal ulcer, smoking, and a baseline FEV1 less than 60% of predicted normal value and a pulmonary exacerbation within the last 2 weeks as defined by use of systemic antibiotic'}, 'identificationModule': {'nctId': 'NCT01303068', 'briefTitle': 'Detection of Pseudomonas Aeruginosa in the Airways of Patients With CF', 'organization': {'class': 'OTHER', 'fullName': 'University of New Mexico'}, 'officialTitle': 'Detection of Pseudomonas. Aeruginosa in the Airways of Patients With Cystic Fibrosis Using of Aerosolized 13C-urea', 'orgStudyIdInfo': {'id': 'HRRC, 12-521'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CF patients, 13C urea breath test kit', 'description': 'CF patients with Pseudomonas infection tested with 13C urea breath test', 'interventionNames': ['Device: 13C urea breath test Kit']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy controls, 13C urea breath test kit', 'description': 'Healthy subjects using 13C urea breath test kit', 'interventionNames': ['Device: 13C urea breath test Kit']}], 'interventions': [{'name': '13C urea breath test Kit', 'type': 'DEVICE', 'description': '20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas', 'armGroupLabels': ['CF patients, 13C urea breath test kit', 'Healthy controls, 13C urea breath test kit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Hengameh Raissy, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNM'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of New Mexico', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Associate Professor, Pediatrics', 'investigatorFullName': 'Hengameh Raissy, Pharm.D.', 'investigatorAffiliation': 'University of New Mexico'}}}}