Ignite Creation Date:
2025-12-25 @ 5:10 AM
Ignite Modification Date:
2026-01-03 @ 8:16 PM
Study NCT ID:
NCT01792427
Status:
COMPLETED
Last Update Posted:
2013-02-20
First Post:
2013-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mortality in Non-cystic Fibrosis Bronchiectasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 253}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-18', 'studyFirstSubmitDate': '2013-02-13', 'studyFirstSubmitQcDate': '2013-02-13', 'lastUpdatePostDateStruct': {'date': '2013-02-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Identify cause of death', 'timeFrame': '6 years 4 months', 'description': 'If death occurred, the patient file was reassessed to identify cause of death.'}, {'measure': 'risk factor identification for the survival of NCFB', 'timeFrame': '6 years 4 months', 'description': 'The investigators will evaluate the impact of etiology, number of different bacteriological species in retrospective and prospective sputa, azithromycin use and presence/development of pulmonary hypertension on survival .'}], 'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '6 years 4 months'}], 'secondaryOutcomes': [{'measure': 'risk factor identification for NCFB', 'timeFrame': '6 years 4 months', 'description': 'The investigators wanted to confirm the known risk factors such as age, gender, smoking history and Pseudomonas aeruginosa.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Non-cystic Fibrosis Bronchiectasis']}, 'descriptionModule': {'briefSummary': 'In this study we analyzed the overall survival for all newly diagnosed patients with non-cystic fibrosis bronchiectasis from June 2006 onwards. The investigators wanted to confirm the known risk factors such as age, gender, smoking history and Pseudomonas aeruginosa and evaluate the impact on survival of etiology, number of different bacteriological species in retrospective and prospective sputa, azithromycin use and presence/development of pulmonary hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'non-cystic fibrosis bronchiectasis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with clinically significant and radiologically proven bronchiectasis\n* Chest CT scan confirming the presence of bronchiectatic lesions and had symptoms of chronic productive cough\n* Bronchiectasis was deemed to be present if there was one or more of the following criteria: a bronchoarterial ratio greater than 1, lack of tapering of the bronchi and visualization of bronchi within 1 cm of costal or paravertebral pleura or abutting the mediastinal pleura\n\nExclusion Criteria:\n\n* diagnosis of cystic fibrosis\n* underlying tumoral problem causing the bronchiectatic lesions (postradiotherapy, secondary immunodeficiency due to chemotherapy or postinfectious due to tumoral obstruction)\n* patients with asymptomatic traction bronchiectasis caused by interstitial lung disease'}, 'identificationModule': {'nctId': 'NCT01792427', 'briefTitle': 'Mortality in Non-cystic Fibrosis Bronchiectasis', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Mortality in Non-cystic Fibrosis Bronchiectasis: a Long-term Cohort Analysis', 'orgStudyIdInfo': {'id': 'B51060'}, 'secondaryIdInfos': [{'id': 'B32220084152', 'type': 'OTHER', 'domain': 'Belgium: Institutional Review Board'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams-Brabant', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Pieter Goeminne, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'prof. dr.', 'investigatorFullName': 'Dr. Lieven Dupont', 'investigatorAffiliation': 'Universitaire Ziekenhuizen KU Leuven'}}}}