Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-03-05 @ 9:41 AM
Study NCT ID:
NCT01842360
Status:
COMPLETED
Last Update Posted:
2025-10-02
First Post:
2013-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Efficacy and Safety of MV130 in Chronic Obstructive Pulmonary Disease (COPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mcasanovas@inmunotek.com', 'phone': '34691490175', 'title': 'Miguel Casanovas', 'organization': 'Inmunotek S.L'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'from enrollment until end of follow-up, 18 months', 'eventGroups': [{'id': 'EG000', 'title': 'MV130', 'description': 'The participants will receive daily dose of MV130 during 12 months\n\nMV130: The participants will receive daily dose of MV130 during 12 months', 'otherNumAtRisk': 97, 'deathsNumAtRisk': 97, 'otherNumAffected': 26, 'seriousNumAtRisk': 97, 'deathsNumAffected': 1, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Placebo', 'description': 'The participants will receive daily dose of placebo during 12 months\n\nPlacebo: The participants will receive daily dose of placebo during 12 months', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 13, 'seriousNumAtRisk': 101, 'deathsNumAffected': 2, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'seriousEvents': [{'term': 'metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Brain neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Aenocarcinoma pancreas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Unstable angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Petit mal epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Apendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pulmonary aspergillosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Mycobacterium avium complex infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cytomegalovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 101, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of COPD Exacerbations.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active - MV130', 'description': 'The participants will receive daily dose of MV130 during 12 months sublingually.\n\nMV130: The participants will receive daily dose of MV130 during 12 months sublingually.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The participants will receive daily dose of placebo during 12 months sublingually.\n\nPlacebo: The participants will receive daily dose of placebo during 12 months sublingually.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '5.0'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '18 months', 'description': 'Comparison in the number of COPD exacerbations in the two study groups in the 18-month study period.', 'unitOfMeasure': 'number of exacerbations', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in the Rate of COPD Exacerbations.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active - MV130', 'description': 'The participants will receive daily dose of MV130 during 12 months sublingually.\n\nMV130: The participants will receive daily dose of MV130 during 12 months sublingually.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The participants will receive daily dose of placebo during 12 months sublingually.\n\nPlacebo: The participants will receive daily dose of placebo during 12 months sublingually.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.86', 'groupId': 'OG000'}, {'value': '2.67', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'Poisson', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '18 months', 'description': 'Incidence is the number of new events per total participants in the sample population.', 'unitOfMeasure': 'events per participant-year', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Severity of COPD Exacerbations.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active - MV130', 'description': 'The participants will receive daily dose of MV130 during 12 months sublingually.\n\nMV130: The participants will receive daily dose of MV130 during 12 months sublingually.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The participants will receive daily dose of placebo during 12 months sublingually.\n\nPlacebo: The participants will receive daily dose of placebo during 12 months sublingually.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '5.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '23.0'}]}]}], 'analyses': [{'pValue': '0.0094', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'The mean of health care consumption was 17.5±34.7 points in the placebo group versus 9.2±27.9 points in the MV130 group.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '18 months', 'description': 'The severity of exacerbations was to be measured by the consumption of health care resources:\n\nEmergency Department/Hospitalisation/Intensive Care Unit/Consultations visits, as follows:\n\nICU hospitalisation 4 points Hospitalisation 3 points Emergency room visit 2 points Consultation resulting in change in usual treatment 1 point', 'unitOfMeasure': 'points', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time Elapsed Between Start of Treatment and First COPD Exacerbation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active - MV130', 'description': 'The participants will receive daily dose of MV130 during 12 months sublingually.\n\nMV130: The participants will receive daily dose of MV130 during 12 months sublingually.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The participants will receive daily dose of placebo during 12 months sublingually.\n\nPlacebo: The participants will receive daily dose of placebo during 12 months sublingually.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.35', 'groupId': 'OG000', 'lowerLimit': '4.41', 'upperLimit': '9.00'}, {'value': '4.42', 'groupId': 'OG001', 'lowerLimit': '3.38', 'upperLimit': '6.61'}]}]}], 'analyses': [{'pValue': '0.3917', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '18 months', 'description': 'For reference, median survival or event-free times are reported with the 95% CI of the median.', 'unitOfMeasure': 'number of months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Use of Drugs (Antibiotics, Corticosteroids, Etc).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active - MV130', 'description': 'The participants will receive daily dose of MV130 during 12 months sublingually.\n\nMV130: The participants will receive daily dose of MV130 during 12 months sublingually.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The participants will receive daily dose of placebo during 12 months sublingually.\n\nPlacebo: The participants will receive daily dose of placebo during 12 months sublingually.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '71.0'}, {'value': '40.0', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': '112.0'}]}]}], 'analyses': [{'pValue': '0.0232', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'As for the previous index the number of days with any of these drugs is used.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '18 months', 'description': 'The use of drugs will be calculated using the following index:\n\n* antibiotics: 1 point\n* inhaled corticosteroids: 2 points\n* systemic corticosteroids: 3 points', 'unitOfMeasure': 'points', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Hospitalizations Due to a COPD Exacerbation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active - MV130', 'description': 'The participants will receive daily dose of MV130 during 12 months sublingually.\n\nMV130: The participants will receive daily dose of MV130 during 12 months sublingually.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The participants will receive daily dose of placebo during 12 months sublingually.\n\nPlacebo: The participants will receive daily dose of placebo during 12 months sublingually.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.0'}]}]}], 'analyses': [{'pValue': '0.0319', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '18 months', 'description': 'The same patient could have more than one hospitalizations.', 'unitOfMeasure': 'number of hospitalizations', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Days of Hospitalization Due to a COPD Exacerbation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active - MV130', 'description': 'The participants will receive daily dose of MV130 during 12 months sublingually.\n\nMV130: The participants will receive daily dose of MV130 during 12 months sublingually.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The participants will receive daily dose of placebo during 12 months sublingually.\n\nPlacebo: The participants will receive daily dose of placebo during 12 months sublingually.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '6.0'}]}]}], 'analyses': [{'pValue': '0.0264', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '18 months', 'description': 'Number of days of hospitalization per patient were recorded. The same patient could have more than one hospitalization.', 'unitOfMeasure': 'number of days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Visits to the Emergency Room.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active - MV130', 'description': 'The participants will receive daily dose of MV130 during 12 months sublingually.\n\nMV130: The participants will receive daily dose of MV130 during 12 months sublingually.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The participants will receive daily dose of placebo during 12 months sublingually.\n\nPlacebo: The participants will receive daily dose of placebo during 12 months sublingually.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.0'}]}]}], 'analyses': [{'pValue': '0.0037', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'The mean number of emergency room visits was 0.37 (±1.15) for the MV130 group and 0.87 (±1.61) for the placebo group.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '18 months', 'description': 'Number of individual visits were recorded per patient. One patient could have multiple visits.', 'unitOfMeasure': 'number of visits', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Unscheduled Medical Consultations Due to COPD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active - MV130', 'description': 'The participants will receive daily dose of MV130 during 12 months sublingually.\n\nMV130: The participants will receive daily dose of MV130 during 12 months sublingually.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The participants will receive daily dose of placebo during 12 months sublingually.\n\nPlacebo: The participants will receive daily dose of placebo during 12 months sublingually.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}], 'analyses': [{'pValue': '0.1008', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'The mean number of medical consultations was 0.08 (±0.31) for the MV130 group and 0.31 (±0.88) for the placebo group.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '18 months.', 'description': 'Number of consultations per patient. One patient could have multiple consultations.', 'unitOfMeasure': 'number of consultations', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Health Related Quality of Life.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active - MV130', 'description': 'The participants will receive daily dose of MV130 during 12 months sublingually.\n\nMV130: The participants will receive daily dose of MV130 during 12 months sublingually.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The participants will receive daily dose of placebo during 12 months sublingually.\n\nPlacebo: The participants will receive daily dose of placebo during 12 months sublingually.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'groupId': 'OG000', 'lowerLimit': '-7.0', 'upperLimit': '1.5'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-5.0', 'upperLimit': '3.0'}]}]}], 'analyses': [{'pValue': '0.0367', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '18 months', 'description': 'COPD Assessment Test per patient determined by an adapted version of the specific COPD Assessment Test. Minimum value is 0 (better) and maximum value is 40 (worse). The change between two or more time points is reported. Change between baseline and 18 months in shown.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Healthcare Resource Utilization During COPD Exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active - MV130', 'description': 'The participants will receive daily dose of MV130 during 12 months sublingually.\n\nMV130: The participants will receive daily dose of MV130 during 12 months sublingually.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The participants will receive daily dose of placebo during 12 months sublingually.\n\nPlacebo: The participants will receive daily dose of placebo during 12 months sublingually.'}], 'classes': [{'categories': [{'measurements': [{'value': '5202', 'groupId': 'OG000'}, {'value': '8231', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '18 months', 'description': 'Healthcare resource utilization was assessed as the sum of:\n\n* Complementary tests\n* Programmed visits to the specialist\n* Total number of visits to the specialist\n* Non-programmed visits to the specialist\n* ICU hospitalization days\n* Visits to the emergency room\n* Days hospitalized\n* Sum of antibiotics\n* Number of visits to General Practitioner\n* Sum of oral corticosteroids\n* Number of telephone calls to the GP\n* Sum of inhalers\n* Home visits\n* Sum of antipyretics\n\nTotal number of healthcare resources used during COPD exacerbation episodes. Data were summarized per treatment group and reported as total counts and percent differences. No baseline or monetary data were collected', 'unitOfMeasure': 'Total number of resource units', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Events and Overall Tolerability (Adverse Reactions).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active - MV130', 'description': 'The participants will receive daily dose of MV130 during 12 months sublingually.\n\nMV130: The participants will receive daily dose of MV130 during 12 months sublingually.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The participants will receive daily dose of placebo during 12 months sublingually.\n\nPlacebo: The participants will receive daily dose of placebo during 12 months sublingually.'}], 'classes': [{'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3234', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '18 months', 'description': 'Total number of adverse events in Active (MV130) and Placebo groups were compared.', 'unitOfMeasure': 'number of events', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Number of Exacerbation-Free Participants During the Follow-up Period (Month 12 to Month 18).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active - MV130', 'description': 'The participants will receive daily dose of MV130 during 12 months sublingually.\n\nMV130: The participants will receive daily dose of MV130 during 12 months sublingually.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The participants will receive daily dose of placebo during 12 months sublingually.\n\nPlacebo: The participants will receive daily dose of placebo during 12 months sublingually.'}], 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 month follow-up period', 'description': 'Number of Participants who were free of exacerbation during the 6 month follow-up period were compared between active and placebo groups.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Number of Exacerbations, Graded by Exacerbation Severity, at Different Study Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active - MV130', 'description': 'The participants will receive daily dose of MV130 during 12 months sublingually.\n\nMV130: The participants will receive daily dose of MV130 during 12 months sublingually.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The participants will receive daily dose of placebo during 12 months sublingually.\n\nPlacebo: The participants will receive daily dose of placebo during 12 months sublingually.'}], 'classes': [{'title': 'Mild exacerbations - 3 months', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': 'Mild exacerbations - 6 months', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': 'Mild exacerbations - 12 months', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': 'Mild exacerbations - 18 months', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': 'Mild exacerbations - Follow up', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': 'Moderate exacerbations - 3 months', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.0'}]}]}, {'title': 'Moderate exacerbations - 6 months', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.0'}]}]}, {'title': 'Moderate exacerbations - 12 months', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '3.0'}]}]}, {'title': 'Moderate exacerbations - 18 months', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '4.0'}]}]}, {'title': 'Moderate exacerbations - Follow up', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.0'}]}]}, {'title': 'Severe exacerbations - 3 months', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': 'Severe exacerbations - 6 months', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': 'Severe exacerbations - 12 months', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.0'}]}]}, {'title': 'Severe exacerbations - 18 months', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.0'}]}]}, {'title': 'Severe exacerbations - Follow up', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': 'Total - 3 months', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.0'}]}]}, {'title': 'Total - 6 months', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.0'}]}]}, {'title': 'Total - 12 months', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '4.0'}]}]}, {'title': 'Total - 18 months', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '5.0'}]}]}, {'title': 'Total - Follow up', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3, 6, 12, 18 months and follow-up.', 'description': 'Cumulated rate of COPD exacerbations per participant, graded by severity, at different time points (change from baseline to 3, 6, 12, and 18 months and follow-up (change from month 12 to 18)).', 'unitOfMeasure': 'number of exacerbations', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MV130', 'description': 'The participants will receive daily dose of MV130 during 12 months\n\nMV130: The participants will receive daily dose of MV130 during 12 months'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'The participants will receive daily dose of placebo during 12 months\n\nPlacebo: The participants will receive daily dose of placebo during 12 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '79'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '22'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MV130', 'description': 'The participants will receive daily dose of MV130 during 12 months\n\nMV130: The participants will receive daily dose of MV130 during 12 months'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'The participants will receive daily dose of placebo during 12 months\n\nPlacebo: The participants will receive daily dose of placebo during 12 months'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.0', 'spread': '9.3', 'groupId': 'BG000'}, {'value': '70.0', 'spread': '8.9', 'groupId': 'BG001'}, {'value': '69.0', 'spread': '9.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '197', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '76.2', 'spread': '15.6', 'groupId': 'BG000'}, {'value': '73.5', 'spread': '15.2', 'groupId': 'BG001'}, {'value': '74.8', 'spread': '15.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '27.8', 'spread': '4.5', 'groupId': 'BG000'}, {'value': '27.5', 'spread': '4.7', 'groupId': 'BG001'}, {'value': '27.6', 'spread': '4.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'FEV1', 'classes': [{'categories': [{'measurements': [{'value': '55.7', 'spread': '14.5', 'groupId': 'BG000'}, {'value': '56.9', 'spread': '14.6', 'groupId': 'BG001'}, {'value': '56.3', 'spread': '14.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Forced Expiratory Volume in 1 second', 'unitOfMeasure': 'liters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoking status', 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'current smokers at baseline visit', 'unitOfMeasure': 'Participants'}, {'title': 'CAT', 'classes': [{'categories': [{'measurements': [{'value': '13.9', 'spread': '6.8', 'groupId': 'BG000'}, {'value': '13.2', 'spread': '7.2', 'groupId': 'BG001'}, {'value': '13.5', 'spread': '6.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'COPD Assessment Test Score', 'unitOfMeasure': 'Score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'VAS', 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '7.0', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '7.0', 'spread': '1.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Visual Analogue Scale (VAS) at baseline. Minimum score is 0 and maximum is 10; 0 being feeling worst and 10 feeling best.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-12-29', 'size': 13026172, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-05-19T10:06', 'hasProtocol': True}, {'date': '2022-11-04', 'size': 2819807, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-05-14T08:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 198}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2013-04-22', 'resultsFirstSubmitDate': '2025-05-20', 'studyFirstSubmitQcDate': '2013-04-24', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-30', 'studyFirstPostDateStruct': {'date': '2013-04-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of COPD Exacerbations.', 'timeFrame': '18 months', 'description': 'Comparison in the number of COPD exacerbations in the two study groups in the 18-month study period.'}], 'secondaryOutcomes': [{'measure': 'Change in the Rate of COPD Exacerbations.', 'timeFrame': '18 months', 'description': 'Incidence is the number of new events per total participants in the sample population.'}, {'measure': 'Change in Severity of COPD Exacerbations.', 'timeFrame': '18 months', 'description': 'The severity of exacerbations was to be measured by the consumption of health care resources:\n\nEmergency Department/Hospitalisation/Intensive Care Unit/Consultations visits, as follows:\n\nICU hospitalisation 4 points Hospitalisation 3 points Emergency room visit 2 points Consultation resulting in change in usual treatment 1 point'}, {'measure': 'Time Elapsed Between Start of Treatment and First COPD Exacerbation.', 'timeFrame': '18 months', 'description': 'For reference, median survival or event-free times are reported with the 95% CI of the median.'}, {'measure': 'Use of Drugs (Antibiotics, Corticosteroids, Etc).', 'timeFrame': '18 months', 'description': 'The use of drugs will be calculated using the following index:\n\n* antibiotics: 1 point\n* inhaled corticosteroids: 2 points\n* systemic corticosteroids: 3 points'}, {'measure': 'Number of Hospitalizations Due to a COPD Exacerbation.', 'timeFrame': '18 months', 'description': 'The same patient could have more than one hospitalizations.'}, {'measure': 'Days of Hospitalization Due to a COPD Exacerbation.', 'timeFrame': '18 months', 'description': 'Number of days of hospitalization per patient were recorded. The same patient could have more than one hospitalization.'}, {'measure': 'Number of Visits to the Emergency Room.', 'timeFrame': '18 months', 'description': 'Number of individual visits were recorded per patient. One patient could have multiple visits.'}, {'measure': 'Number of Unscheduled Medical Consultations Due to COPD', 'timeFrame': '18 months.', 'description': 'Number of consultations per patient. One patient could have multiple consultations.'}, {'measure': 'Health Related Quality of Life.', 'timeFrame': '18 months', 'description': 'COPD Assessment Test per patient determined by an adapted version of the specific COPD Assessment Test. Minimum value is 0 (better) and maximum value is 40 (worse). The change between two or more time points is reported. Change between baseline and 18 months in shown.'}, {'measure': 'Healthcare Resource Utilization During COPD Exacerbations', 'timeFrame': '18 months', 'description': 'Healthcare resource utilization was assessed as the sum of:\n\n* Complementary tests\n* Programmed visits to the specialist\n* Total number of visits to the specialist\n* Non-programmed visits to the specialist\n* ICU hospitalization days\n* Visits to the emergency room\n* Days hospitalized\n* Sum of antibiotics\n* Number of visits to General Practitioner\n* Sum of oral corticosteroids\n* Number of telephone calls to the GP\n* Sum of inhalers\n* Home visits\n* Sum of antipyretics\n\nTotal number of healthcare resources used during COPD exacerbation episodes. Data were summarized per treatment group and reported as total counts and percent differences. No baseline or monetary data were collected'}, {'measure': 'Adverse Events and Overall Tolerability (Adverse Reactions).', 'timeFrame': '18 months', 'description': 'Total number of adverse events in Active (MV130) and Placebo groups were compared.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vaccine', 'Chronic obstructive pulmonary disease (COPD)', 'Exacerbations', 'Prevention', 'Sublingual'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn whether the bacterial vaccine MV130 helps reduce the number of exacerbations in adults with moderate to severe COPD. It will also assess the safety and immune effects of MV130. The main questions it aims to answer is: Does MV130 lower the number and severity of COPD flare-ups? Other questions include: Does it reduce the use of healthcare resources and improve quality of life?\n\nResearchers will compare MV130 to a placebo (a similar spray without the active substance; bacterial species) to see how well it works. Participants will use either MV130 or placebo daily under the tongue for 12 months, attend regular clinic visits, and be followed for an additional 6 months to monitor health outcomes and side effects.', 'detailedDescription': 'This was a randomized, double-blind, placebo-controlled, prospective, parallel, multicenter clinical trial designed to evaluate the efficacy, safety, and immunomodulatory effects of a sublingually administered bacterial polyvalent vaccine (BACTEK®, also known as MV130) in adult participants with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). The study was conducted by Inmunotek, S.L., and included seven sHospitals across Spain. A total of 198 participants were enrolled and randomized equally into two groups to receive either MV130 or placebo over a period of 12 months, followed by a 6-month observation phase, totaling 18 months of participation per participant.\n\nThe investigational product, MV130, consisted of a glycerinated suspension containing six inactivated non-lysate bacterial species: Streptococcus pneumoniae, Staphylococcus epidermidis, Staphylococcus aureus, Klebsiella pneumoniae, Moraxella catarrhalis, and Haemophilus influenzae. The product was administered sublingually at a dosage of two sprays (0.2 mL total) per day. The placebo formulation was identical in appearance and composition, excluding the active bacterial components. All study participants received their first dose under supervision at the clinical site and were trained for home administration.\n\nEligible participants were between 35 and 85 years old, with a diagnosis of moderate or severe COPD according to GOLD guidelines, a history of recurrent exacerbations (≥3 moderate or ≥2 with at least one hospitalization in the past year), and a smoking history of at least 10 pack-years. Subjects were excluded if they had very severe COPD, a history of recent exacerbations or systemic corticosteroid use, concurrent immunodeficiency or serious comorbid conditions, or if they were pregnant, breastfeeding, or unwilling to use contraception during the study.\n\nThe primary efficacy endpoint was the total number of COPD exacerbations during the full 18-month period. Secondary endpoints included the severity of exacerbations, time to first exacerbation, healthcare resource usage (hospitalizations, emergency room visits, unscheduled consultations), medication use, health-related quality of life (assessed using the CAT questionnaire), and a pharmacoeconomic evaluation based on healthcare expenditures. In a subset of participants, immunological parameters were also assessed to explore the immunomodulatory response. Safety analysis included all randomized participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written informed consent.\n* Both sexes.\n* Age between 35 and 85.\n* Must be capable of complying with the dosing regimen.\n* Diagnosis of moderate or severe COPD according to GOLD criteria.\n* Experienced at least three moderate exacerbations (i.e., those requiring treatment with antibiotics, systemic corticosteroids, or both, as prescribed by their general practitioner or pulmonologist in the standard consultation and/or the Emergency Department of their Clinic) or two exacerbations with at least one requiring hospitalization due to a COPD exacerbation and the other one a moderate exacerbation occurred within the last year.\n* Not changed their medication for the maintenance treatment of COPD within the past 6 months.\n* Consumption of 10 or more packs of cigarettes/year. Participants may be or not active smokers.\n* Live in the Autonomous Community of Madrid throughout the study period.\n* Women of childbearing age women of must use an approved contraceptive method and obtain a negative result in the urine pregnancy test performed during the screening visit.\n\nExclusion Criteria:\n\n* Participants outside allowed age range.\n* Participants unable to cooperate and/or have a severe psychiatric disorder.\n* Women who are pregnant, breastfeeding, expect to become pregnant during the study (including assisted reproduction), or who refuse to use contraceptives during the study (including barrier methods). Women who become pregnant during the clinical trial will have to discontinue their participation in it.\n* Participants who has participated in a study or clinical trial with an investigational product in the last 3 months before inclusion.\n* Participants diagnosed with asthma based on the guidelines of the American Thoracic Society and the European Respiratory Society. If the investigators are unable to differentiate between COPD and asthma after applying the criteria listed in the following table, a bronchodilator test with inhaled salbutamol must be performed, excluding those subjects with FEV1 changes \\>400 ml.\n* Participants with a diagnosis other than COPD that causes them to have an unstable condition or a life expectancy \\<3 years.\n* Participants who had an exacerbation within 4 weeks before starting the trial.\n* Participants with moderate COPD who required treatment with inhaled corticosteroids in the last 4 weeks.\n* Participants with moderate COPD who received systemic corticosteroids (orally, intramuscularly, or intravenously) in the last 4 weeks.\n* Participants diagnosed with a Primary or Secondary Immunodeficiency within the 12 months preceding their inclusion in the clinical trial or the trial's baseline visit.\n* Participants diagnosed with chronic lymphoproliferative disease.\n* Participants diagnosed with chronic infectious disease.\n* Participants with chronic heart disease, arrhythmias, or episodes of arrhythmia secondary to the administration of bronchodilators.\n* Participants diagnosed with COPD and chronic colonization by Pseudomonas aeruginosa.\n* Participants with COPD and bronchiectasis diagnosed by CT imaging before the age of 40.\n* Participants diagnosed with very severe COPD according to the GOLD classification.\n* Participants requiring home oxygen therapy or non-invasive mechanical ventilation.\n* Participants with a history of hypersensitivity to any of the vaccine's components.\n* Participants receiving immunosuppressive treatment with: azathioprine, methotrexate, ciclosporin, cyclophosphamide, tacrolimus, antimalarial drugs, or gold salts.\n* Participants who have been treated with monoclonal antibodies such as rituximab or TNF-alpha inhibitors in the last 6 months.\n* Participants receiving chronic treatment with azithromycin or inhaled antibiotics (tobramycin or colistin)."}, 'identificationModule': {'nctId': 'NCT01842360', 'acronym': 'MV130', 'briefTitle': 'Evaluation of the Efficacy and Safety of MV130 in Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Inmunotek S.L.'}, 'officialTitle': 'Randomized Double-blind Placebo-controlled Multicenter Clinical Trial of Bacterial Polyvalent Vaccine (BACTEK®), Administered Sublingually in COPD Patients, to Evaluate Efficacy, Safety, and Immunomodulatory Response.', 'orgStudyIdInfo': {'id': 'MV130-SLG-001'}, 'secondaryIdInfos': [{'id': '2012-003253-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active - MV130', 'description': 'The participants will receive daily dose of MV130 during 12 months sublingually.', 'interventionNames': ['Biological: MV130']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The participants will receive daily dose of placebo during 12 months sublingually.', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'The participants will receive daily dose of placebo during 12 months sublingually.', 'armGroupLabels': ['Placebo']}, {'name': 'MV130', 'type': 'BIOLOGICAL', 'description': 'The participants will receive daily dose of MV130 during 12 months sublingually.', 'armGroupLabels': ['Active - MV130']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08500', 'city': 'Vic', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitario de Vic', 'geoPoint': {'lat': 41.93012, 'lon': 2.25486}}, {'zip': '28850', 'city': 'Torrejón de Ardoz', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario de Torrejón', 'geoPoint': {'lat': 40.45535, 'lon': -3.46973}}, {'zip': '28007', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital General Universitario Gregorio Marañón', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28031', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Infanta Leonor', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clínico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Eduardo Fernández Cruz, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital General Universitario Gregorio Marañón'}, {'name': 'Javier de Miguel Díez, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital General Universitario Gregorio Marañón'}, {'name': 'José Luis Álvarez-Sala, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital San Carlos, Madrid'}, {'name': 'María J Buendía, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Infanta Leonor'}, {'name': 'Carlos J Álvarez, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario 12 de Octubre'}, {'name': 'Soledad Alonso, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario de Torrejón,Madrid'}, {'name': 'Francisco García, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario La Paz'}, {'name': 'Joan Serra, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de Universitario Vic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inmunotek S.L.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}