Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT04056702
Status:
UNKNOWN
Last Update Posted:
2021-03-11
First Post:
2019-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Triple Combination CFTR Therapy on Sinus Disease.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 31}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-09', 'studyFirstSubmitDate': '2019-07-27', 'studyFirstSubmitQcDate': '2019-08-12', 'lastUpdatePostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Sinus CT opacification.', 'timeFrame': 'Change in Sinus CT opacification between the initial and 6 month visits.', 'description': 'Calculated from an automated quantification of the size of sinuses.'}], 'secondaryOutcomes': [{'measure': 'Change in 22-item Sino-Nasal Outcome Test (SNOT-22) score.', 'timeFrame': 'Change in SNOT-22 score between the initial and 6 month visits.', 'description': 'Validated, disease-specific measure of sinus symptoms. Contains 22 questions that are all scored from 0 to 5, when summed a total score ranges form 0 to 110. Higher scores represent worse sinus symptoms.'}, {'measure': 'Change in Questionnaire for Olfactory Disorders (QOD) score', 'timeFrame': 'Change in QOD score between the initial and 6 month visits.', 'description': 'Validated, disease-specific measure of olfaction, i.e. the ability to smell. Contains 19 questions that are scored form 0 to 3, when summed a total score can range form 0 to 57. Higher scores indicate greater impact on a subjects sense of smell.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Sinusitis'], 'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': "The study's main goal is to observe how effective elexacaftor-tezacaftor-ivacaftor is for improving the symptoms and signs of CF-related sinus disease.", 'detailedDescription': 'To determine if elexacfator-tezacaftor-ivacaftor improves the signs and symptoms of CF-related sinus disease, before and after initiation of triple combination therapy, each subject will undergo sinus CT scan and complete questionnaires related to signs and symptoms of sinus disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People with cystic fibrosis and chronic sinusitis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects from 18 to 89 years old.\n2. Subjects with cystic fibrosis and comorbid chronic sinus disease (historic diagnosis based on physician assessment of signs and symptoms and medical record).\n3. Subjects who clinically elect to initiate elexacaftor-tezacaftor-ivacaftor therapy and/or that are ineligible for CFTR modulator therapy based on their genotype, but have class I/II mutations based on sweat chloride \\> 90 mmol/L.\n\nExclusion Criteria:\n\n1. Subjects under the age of 18 or over the age of 89.\n2. Subjects who do not elect to initiate elexacaftor-tezacaftor-ivacaftor for clinical reasons.\n3. Subjects who had sinus surgery within the last 6 months or will have sinus surgery during the study period.\n4. Subjects who have had a recent pulmonary exacerbation or viral infection within two weeks of initial visit.'}, 'identificationModule': {'nctId': 'NCT04056702', 'briefTitle': 'Impact of Triple Combination CFTR Therapy on Sinus Disease.', 'organization': {'class': 'OTHER', 'fullName': 'National Jewish Health'}, 'officialTitle': 'Impact of Elexacaftor-tezacaftor-ivacaftor Triple Combination CFTR Therapy on Sinus Disease: Quantitative Sinus Computed Tomography, Patient Reported Outcomes and Cellular and Molecular Changes', 'orgStudyIdInfo': {'id': 'HS-3236'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prescribed triple combination', 'description': 'A group of 60 people with CF who are clinically prescribed elexacaftor-tezacaftor-ivacaftor and have chronic sinusitis', 'interventionNames': ['Drug: Elexacaftor-tezacaftor-ivacaftor exposure']}, {'label': 'Not eligible for modulators', 'description': 'A group of 10 patients with two class I/II mutations who are ineligible for elexacaftor-tezacaftor-ivacaftor based on their genotype and have chronic sinusitis.'}], 'interventions': [{'name': 'Elexacaftor-tezacaftor-ivacaftor exposure', 'type': 'DRUG', 'description': 'Once a clinical decision has been made to prescribed a patient triple combination therapy, people with CF are eligible to participate in this study.', 'armGroupLabels': ['Prescribed triple combination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80206', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Connor Balkissoon', 'role': 'CONTACT', 'email': 'balkissoonc@njhealth.org', 'phone': '303-270-2768'}], 'facility': 'National Jewish Health', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'centralContacts': [{'name': 'Connor Balkissoon', 'role': 'CONTACT', 'email': 'balkissoonc@njhealth.org', 'phone': '877-225-5654', 'phoneExt': '2768'}], 'overallOfficials': [{'name': 'Jennifer TaylorCousar, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Jewish Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jennifer Taylor-Cousar', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cystic Fibrosis Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Jennifer Taylor-Cousar', 'investigatorAffiliation': 'National Jewish Health'}}}}