Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2026-01-04 @ 8:34 AM
Study NCT ID:
NCT03534557
Status:
COMPLETED
Last Update Posted:
2018-09-05
First Post:
2018-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FEV1/FEV6 and FEV6 as an Alternative for FEV1/FVC and FVC in Bolivian Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-04', 'studyFirstSubmitDate': '2018-05-08', 'studyFirstSubmitQcDate': '2018-05-22', 'lastUpdatePostDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The aim of this preliminary study is to determine if the criteria of airway obstruction using FEV6 as a surrogate of FVC are transposable to a non-selected Bolivian population', 'timeFrame': 'one measurement lasts 10 minutes', 'description': 'see above'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['spirometry'], 'conditions': ['Copd']}, 'descriptionModule': {'briefSummary': 'Comparison of FEV1/FEV6 and FEV6 as an alternative for FEV1/FVC and FCV in the detection of airway obstruction in a Bolivian population', 'detailedDescription': "The data of consecutive adult smoker patients, referred to the Clínica del Pulmón (Santa Cruz, Bolivia), between May 2018 and June 2018, will be analyzed. All the patients are current or ex-smokers, complaining of dyspnea, cough or expectorations. Spirometry measurements will be performed with a Medisoft Body Box 5500 by one highly trained and experienced pulmonologist according to the guidelines of the ATS/ERS.\n\nThe criteria used to detect airway obstruction are either the fixed cut-off points according to GOLD recommendations (FEV1/FVC\\<0.70) or the lower limit of normal (FEV1/FVC\\<LLN). These indices will be compared to a fixed cut-off FEV1/FEV6 \\<0.73 as proposed by Vandevoorde et al. or to a FEV1/FV6 ration \\< LLN. Reference equations used are those of Caucasians from the NHANES III survey.\n\nStatistical tests will be done using IBM SPSS 24 software. Cohen's κ will be used to determine if there is an agreement between the definitions of airway obstruction."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'COPD', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult smoker suspected of COPD\n\nExclusion Criteria:\n\n* unable to perform spirometry'}, 'identificationModule': {'nctId': 'NCT03534557', 'briefTitle': 'FEV1/FEV6 and FEV6 as an Alternative for FEV1/FVC and FVC in Bolivian Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': 'FEV1/FEV6 and FEV6 as an Alternative for FEV1/FVC and FVC in the Detection of Airway Obstruction in a Small Group of Bolivian Subjects', 'orgStudyIdInfo': {'id': 'StLucFEV6'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COPD', 'description': 'FEV1/FVC and FEV1/FEV6 will be compared within the same cohort of COPD patients', 'interventionNames': ['Diagnostic Test: FEV6 spirometry']}], 'interventions': [{'name': 'FEV6 spirometry', 'type': 'DIAGNOSTIC_TEST', 'description': 'During the same spirometry, to compare the relative value of FVC and FEV6', 'armGroupLabels': ['COPD']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santa Cruz', 'country': 'Bolivia', 'facility': 'Clínica del Pulmón', 'geoPoint': {'lat': -21.75, 'lon': -65.31667}}], 'overallOfficials': [{'name': 'Giuseppe Liistro, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of clinic', 'investigatorFullName': 'Giuseppe Liistro', 'investigatorAffiliation': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}}}}