Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 5:49 AM
Study NCT ID:
NCT03432234
Status:
UNKNOWN
Last Update Posted:
2020-01-23
First Post:
2018-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Respiratory Microbiome and COPD Exacerbations (RESMECOPD)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015415', 'term': 'Biomarkers'}], 'ancestors': [{'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Oral Wash, oropharingeal swab, sputum, brochoalveolar lavage, feces, plasma, serum, white blood cells.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-22', 'studyFirstSubmitDate': '2018-01-08', 'studyFirstSubmitQcDate': '2018-02-07', 'lastUpdatePostDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Spatial variability of respiratory microbiome in COPD patients (FE vs NE).', 'timeFrame': '1 day', 'description': 'Respiratory Microbiome Composition of different types of samples.'}], 'primaryOutcomes': [{'measure': 'Respiratory Microbiome in COPD patients with FE and NE.', 'timeFrame': '7 days', 'description': 'Respiratory Microbiome composition will be determined by using metagenomic aproaches.'}], 'secondaryOutcomes': [{'measure': 'Bacteria related to pulmonary and systemic inflamatory factors (FE vs NE)', 'timeFrame': '7 days', 'description': 'Determination of pulmonary and systemic markers with ELISA kit. Microbiome will be determined by metagenomic techniques.'}, {'measure': 'Longitudinal variability of respiratory microbiome in COPD patients (FE vs NE).', 'timeFrame': '12 months', 'description': 'Change of respiratory Microbiome (diversity and abundance)'}, {'measure': 'Inmunological response of lung epithelial cells COPD patients after an infectious and inflammatory stimuli', 'timeFrame': '7 days', 'description': 'The in vitro response of epithelial cells will be determined with ELISA kits.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD', 'Microbiome', 'Exacerbation'], 'conditions': ['Pulmonary Disease, Chronic Obstructive', 'Exacerbation COPD']}, 'descriptionModule': {'briefSummary': 'The global objective of this coordinated project is to test the following hypotheses: 1) the lung microbiome in chronic obstructive pulmonary disease (COPD) is different in patients suffering from frequent exacerbations (FE) compared those who do not (NE ); 2) The microbial profile of patients with FE is associated with a different local and systemic inflammatory pattern; and 3) the inflammatory and immune characteristics of COPD are modulated by the intestinal microbiome.\n\nThe project is based on bronchoalveolar lavage (BAL) for sampling lung microbiome, and includes analysis of regional variability (intrapulmonary) and temporal variability. The project will also assess the correlation between BAL samples obtained from the proximal airway (oral cavity, oropharynx and sputum), and the representation of lung microbiome in them. A cohort of COPD patients (n = 50 FE; n = 50 NE) and healthy subjects (n= 30), matched by age, sex and tobacco consumption. Respiratory secretion samples will be collected in clinical stability samples, with resampling in a quarter of the participants at 6-9 months. Coordinator Project: Bacterial and fungal microbiota will be determined by 16S rRNA and ITS amplification and sequencing. Virome and functional metagenomics will be analyzed in a quarter of the participants. Subprojects: Regional variability in the lung, local and systemic inflammatory response, and the relationship between the intestinal microbiome and inflammatory and clinical characteristics of the disease will be determined. The integration of the results will be performed using network medicine methodologies. The results of this project will help to understand the pathogenesis of COPD and its exacerbations with the final aim to identify new therapeutic targets.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible subjects were COPD patients GOLD II/III in stable situation.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Spirometry: FEV1/FVC \\< 70%; FEV1 between 50 and 80% predicted (GOLD II/III)\n* Clinical Stability (no therapeutic change and/or use of antibiotics) during 8 weeks. - The treatment received will be registered for post-hoc studies stratified by this condition.\n\nExclusion Criteria:\n\n* Drug addiction, alcohol abuse,\n* Use of long-term oral or nebulised antibiotic therapy.\n* History of allergies, asthma or other chronic respiratory disease, sanitary worker, working exposure to dust or fumes.\n* Other diseases: Severe cardiovascular, neurological, psychiatric, renal, hepatic or gastrointestinal , that might interfere with the daily life activities.'}, 'identificationModule': {'nctId': 'NCT03432234', 'acronym': 'RESMECOPD', 'briefTitle': 'Respiratory Microbiome and COPD Exacerbations (RESMECOPD)', 'organization': {'class': 'OTHER', 'fullName': 'Corporacion Parc Tauli'}, 'officialTitle': 'Respiratory Microbiome and COPD Exacerbations', 'orgStudyIdInfo': {'id': 'PI15/0157 (2015607)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COPD and frequent exacerbation', 'description': 'Patient with COPD diagnosis and at least two exacerbations by year (FE)', 'interventionNames': ['Other: Biomarkers']}, {'label': 'COPD no frequent exacerbation', 'description': 'Patient with COPD diagnosis with no frequent exacerbation, less than 2 by year (NE).', 'interventionNames': ['Other: Biomarkers']}, {'label': 'Healthy (control)', 'description': 'Healthy volunteers patients (H)', 'interventionNames': ['Other: Biomarkers']}], 'interventions': [{'name': 'Biomarkers', 'type': 'OTHER', 'description': 'This is an observational study, there is no intervention', 'armGroupLabels': ['COPD and frequent exacerbation', 'COPD no frequent exacerbation', 'Healthy (control)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08208', 'city': 'Sabadell', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Corporació Sanitaria Parc Tauli', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}, {'city': 'Badalona', 'country': 'Spain', 'facility': 'Hospital Germans Trias i Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clínic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de Bellitge', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hosptial de Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Oriol Sibila', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de Sant Pau'}, {'name': 'Rosa Faner', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clínic'}, {'name': 'Eduard Monso', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Parc Tauli'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Sequencing data will be available in public databases.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corporacion Parc Tauli', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital de Sant Pau', 'class': 'OTHER'}, {'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}, {'name': 'Hospital Universitari de Bellvitge', 'class': 'OTHER'}, {'name': 'Hospital del Mar', 'class': 'OTHER'}, {'name': 'Germans Trias i Pujol Hospital', 'class': 'OTHER'}, {'name': 'Hospital Arnau de Vilanova', 'class': 'OTHER'}, {'name': 'Centre for Genomic Regulation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Respiratory Medicine Department', 'investigatorFullName': 'Eduard Monsó-Molas', 'investigatorAffiliation': 'Corporacion Parc Tauli'}}}}