Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-02-21 @ 9:56 PM
Study NCT ID:
NCT02547532
Status:
COMPLETED
Last Update Posted:
2018-08-01
First Post:
2015-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microbioma in Sputa From COPD With Alpha-1 Antitrypsin Deficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019896', 'term': 'alpha 1-Antitrypsin Deficiency'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver 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': 'D013352', 'term': 'Subcutaneous Emphysema'}, {'id': 'D004646', 'term': 'Emphysema'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-31', 'studyFirstSubmitDate': '2015-09-09', 'studyFirstSubmitQcDate': '2015-09-09', 'lastUpdatePostDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'composition of microbioma in sputa', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'correlation with clinical and physiological parameters', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD', 'alpha-1 antitrypsin deficiency', 'microbioma'], 'conditions': ['Alpha-1 Antitrypsin Deficiency']}, 'descriptionModule': {'briefSummary': 'In the context of the increasing evidence of the pathogenetic role of microbiome in COPD, our aim is to determine the total and specific bacterial and viral load in sputa from patients with COPD due to AATD and to correlate these findings with cellular, biochemical and immunological characteristics of sputa. These quantitative data obtained from sputum will be analyzed in the context of the clinical and physiological parameters of the patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Normal volunterrs Patients with COPD without AATD Patients with COPD and with AATD', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of COPD and a clinical stable condition, i.e. at least three months from the last AECOPD and/or antibiotic treatment.\n\nFor patients with AATD this condition will be diagnosed by laboratory tests showing low levels of AAT and genotyping of AATD-related genes.\n\n. Exclusion Criteria:\n\n* The presence of important co-morbidities (diabetes, systemic or organ infections, immunodeficiency, tumors, moderate-severe heart failure) will be considered as exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT02547532', 'acronym': 'AATD', 'briefTitle': 'Microbioma in Sputa From COPD With Alpha-1 Antitrypsin Deficiency', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Salvatore Maugeri'}, 'officialTitle': 'Microbioma in Sputa From COPD With Alpha-1 Antitrypsin Deficiency', 'orgStudyIdInfo': {'id': 'Fsalvatoremaugeri'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'usual COPD', 'description': 'Patients meeting the diagnostic criteria for COPD and without AATD', 'interventionNames': ['Other: collection of sputum']}, {'label': 'normal smokers', 'description': 'subjects with a history of smoking, without symptoms, without AATD and with normal lung function', 'interventionNames': ['Other: collection of sputum']}, {'label': 'normal non smokers', 'description': 'subjects without a history of smoking, without symptoms, without AATD and with normal lung function', 'interventionNames': ['Other: collection of sputum']}, {'label': 'AATD not treated', 'description': 'patients with COPD, with AATD and not on augmentation therapy for AATD', 'interventionNames': ['Other: collection of sputum']}, {'label': 'AATD treated', 'description': 'patients with COPD, with AATD on augmentation therapy for AATD', 'interventionNames': ['Other: collection of sputum']}], 'interventions': [{'name': 'collection of sputum', 'type': 'OTHER', 'armGroupLabels': ['AATD not treated', 'AATD treated', 'normal non smokers', 'normal smokers', 'usual COPD']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pantaleo Giannuzzi, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fondazione Salvatore Maugeri'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Salvatore Maugeri', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondazione IRCCS Policlinico San Matteo di Pavia', 'class': 'OTHER'}, {'name': 'Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia', 'class': 'OTHER'}, {'name': 'Grifols Biologicals, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head, Pulmonary Rehabilitation Department', 'investigatorFullName': 'Bruno Balbi', 'investigatorAffiliation': 'Fondazione Salvatore Maugeri'}}}}