Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2025-12-25 @ 1:40 PM
Study NCT ID:
NCT03839992
Status:
RECRUITING
Last Update Posted:
2023-10-26
First Post:
2019-02-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Detection of Unsuspected Small Airways Obstruction in Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001987', 'term': 'Bronchiectasis'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013147', 'term': 'Spirometry'}], 'ancestors': [{'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2027-11-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-25', 'studyFirstSubmitDate': '2019-02-11', 'studyFirstSubmitQcDate': '2019-02-11', 'lastUpdatePostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of Unsuspected Small Airway Obstruction in Cystic Fibrosis', 'timeFrame': '5 years', 'description': 'Retrospective analysis of pre bronchodilator spirometry, and lung CT study to detect abnormal FEF75% in the presence of normal spirometry and FEF25-75. Detect isolated abnormal pre bronchodilator spirometry at 75%FVC'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['abnormal FEF75', 'bronchiectasis', 'lung CT'], 'conditions': ['Cystic Fibrosis in Children']}, 'referencesModule': {'references': [{'pmid': '5442364', 'type': 'RESULT', 'citation': 'Mead J. The lung\'s "quiet zone". N Engl J Med. 1970 Jun 4;282(23):1318-9. doi: 10.1056/NEJM197006042822311. No abstract available.'}, {'pmid': '4683321', 'type': 'RESULT', 'citation': 'Gelb AF, Gold WM, Wright RR, Bruch HR, Nadel JA. Physiologic diagnosis of subclinical emphysema. Am Rev Respir Dis. 1973 Jan;107(1):50-63. doi: 10.1164/arrd.1973.107.1.50. No abstract available.'}, {'pmid': '4684043', 'type': 'RESULT', 'citation': 'Gelb AF, Zamel N. Simplified diagnosis of small-airway obstruction. N Engl J Med. 1973 Feb 22;288(8):395-8. doi: 10.1056/NEJM197302222880805. No abstract available.'}, {'pmid': '28151425', 'type': 'RESULT', 'citation': 'Hogg JC, Pare PD, Hackett TL. The Contribution of Small Airway Obstruction to the Pathogenesis of Chronic Obstructive Pulmonary Disease. Physiol Rev. 2017 Apr;97(2):529-552. doi: 10.1152/physrev.00025.2015.'}, {'pmid': '26079395', 'type': 'RESULT', 'citation': 'Lukic KZ, Coates AL. Does the FEF25-75 or the FEF75 have any value in assessing lung disease in children with cystic fibrosis or asthma? Pediatr Pulmonol. 2015 Sep;50(9):863-8. doi: 10.1002/ppul.23234. Epub 2015 Jun 16.'}, {'pmid': '36914809', 'type': 'DERIVED', 'citation': 'Masson VK, Nussbaum E, Gelb AF, Tashkin DP, Randhawa I, Nadel JA, Fireizen Y, De Celie-Germana JK, Madera D, Senanayake D. Isolated abnormal FEF75% detects unsuspected bronchiolar obstruction in CF children. Pediatr Res. 2023 Sep;94(3):1051-1056. doi: 10.1038/s41390-023-02532-2. Epub 2023 Mar 13.'}]}, 'descriptionModule': {'briefSummary': 'Goal is to physiologically detect unsuspected small airways obstruction in children and adults with treated heterozygous and homozygous cystic fibrosis. Unsuspected refers to normal routine pre bronchodilator spirometry including normal FEV1(L), FVC (L). and FEV1/FVC%. This is a retrospective study.', 'detailedDescription': 'The current study is based on current investigators previously published patho-physiologic and lung CT studies in small airways intrinsic obstruction, emphysema, and asthma. Current investigators have demonstrated that despite the presence of normal routine spirometry including normal FEV1(L), FVC (L), and FEV1/FVC% that unsuspected small airways obstruction, and emphysema can be detected. This has been achieved by presence of isolated abnormal expiratory airflow limitation at low lung volumes on the maximal expiratory flow volume curves. This includes abnormal expiratory airflow at 75% and 80% expired lung volume. Current investigators believe investigators will be able to detect unsuspected small airways intrinsic obstruction, and peripheral airway bronchiectasis proven by lung CT, in patients with cystic fibrosis despite presence of pre bronchodilator normal routine spirometry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Review pulmonary function and radiologic studies in retrospective records of heterozygote or homozygote patients with cystic fibrosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHeterozygote or homozygote patients with cystic fibrosis with normal routine pre bronchodilator spirometry including normal FEV1(L), FVC(L) and FEV1/FVC%.\n\nExclusion Criteria:Heterozygote or homozygote patients with cystic fibrosis with ABNORMAL routine pre bronchodilator spirometry\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03839992', 'briefTitle': 'Detection of Unsuspected Small Airways Obstruction in Cystic Fibrosis', 'organization': {'class': 'INDIV', 'fullName': 'Gelb, Arthur F., M.D.'}, 'officialTitle': 'The Measurement and Analysis of Maximal Expiratory Flow Volume Loops at Low Lung Volumes in Children With Cystic Fibrosis and Normal Routine Lung Function.', 'orgStudyIdInfo': {'id': 'MHS #843-18'}}, 'armsInterventionsModule': {'interventions': [{'name': 'spirometry', 'type': 'DIAGNOSTIC_TEST', 'description': 'measure spirometry and lung CT'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90712', 'city': 'Lakewood', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Arthur F Gelb, MD', 'role': 'CONTACT', 'email': 'afgelb@msn.com', 'phone': '562-633-2204'}, {'name': 'Christine Fraser', 'role': 'CONTACT', 'email': 'familyfrase@msn.com', 'phone': '562-633-2204'}, {'name': 'Arthur F Gelb, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Arthur F Gelb MD', 'geoPoint': {'lat': 33.85363, 'lon': -118.13396}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vicki C Masson, MD', 'role': 'CONTACT', 'email': 'vicki.masson@gmail.com', 'phone': '631-741-0549', 'phoneExt': '6317410549'}, {'name': 'Eli C Nussbaum, MD', 'role': 'CONTACT', 'email': 'ENussbaum@memorialcare.org', 'phone': '714-356-6830', 'phoneExt': '6317410549'}, {'name': 'Vicki C Masson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Miller Children's Hospital and Long Beach Medical Center", 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}], 'centralContacts': [{'name': 'Arthur F Gelb, MD', 'role': 'CONTACT', 'email': 'afgelb@msn.com', 'phone': '562-565-5333', 'phoneExt': '5625655333'}, {'name': 'Vicki Masson, MD', 'role': 'CONTACT', 'email': 'vicki.masson@gmail.com', 'phone': '631-741-0549', 'phoneExt': '5625655333'}], 'overallOfficials': [{'name': 'Arthur Gelb, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'when published', 'ipdSharing': 'YES', 'description': 'All individual published data will be shared', 'accessCriteria': 'published data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gelb, Arthur F., M.D.', 'class': 'INDIV'}, 'collaborators': [{'name': "Miller Children's & Women's Hospital Long Beach", 'class': 'OTHER'}, {'name': 'Stony Brook University', 'class': 'OTHER'}, {'name': 'The Hospital for Sick Children', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}