Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-31 @ 3:57 AM
Study NCT ID:
NCT05504993
Status:
COMPLETED
Last Update Posted:
2022-08-17
First Post:
2022-08-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Are Comorbidities Related to Frequent Severe Exacerbations of AECOPD
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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-16', 'studyFirstSubmitDate': '2022-08-14', 'studyFirstSubmitQcDate': '2022-08-16', 'lastUpdatePostDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of AECOPD', 'timeFrame': '1 year', 'description': 'Frequency of AECOPD in the last one year'}], 'secondaryOutcomes': [{'measure': 'Having at least one severe AECOPD', 'timeFrame': '1 year', 'description': 'having at least one severe AECOPD in the last year'}, {'measure': 'Frequency of AECOPD for the next one year', 'timeFrame': '1 year', 'description': 'the number of AECOPD for 1 year period from the preceding admission, regardless of severity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Obstructive Lung Disease', 'Acute Exacerbation of COPD', 'Comorbidities and Coexisting Conditions']}, 'descriptionModule': {'briefSummary': 'INTRODUCTION: Relationship between comorbidities and COPD is two-sided. While the number of comorbidities increasing, the frequency of acute exacerbations of COPD (AECOPD) is increasing, too. Comorbidity indexes can be used for recognition of comorbidities while managing COPD patients. In the present study, it is aimed to compare comorbidity indexes such as Charlson Comorbidity Index, COMCOLD and COTE in the matter of exacerbation frequency.\n\nMETHOD: Subjects hospitalized for AECOPD, admitted to the study. Exacerbation severity, frequency, further exacerbations for a 1-year period in the follow-up period and CCI, COMCOLD and COTE scores were recorded. High and low comorbidity groups were compared for AECOPD frequency, severity, and further exacerbations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study included all patients, admitted to pulmonary diseases department, and hospitalized in ward for acute exacerbation of COPD (AECOPD) for a six-month period.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COPD patients\n* Admitted to the ward for AECOPD\n\nExclusion Criteria:\n\n* Not giving informed consent\n* Unable to perform PFT\n* Lost to follow-up'}, 'identificationModule': {'nctId': 'NCT05504993', 'briefTitle': 'Are Comorbidities Related to Frequent Severe Exacerbations of AECOPD', 'organization': {'class': 'OTHER', 'fullName': 'Ankara University'}, 'officialTitle': 'Are Comorbidities Related to Frequent Severe Exacerbations of AECOPD', 'orgStudyIdInfo': {'id': '05-305-18'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High comorbidity group', 'description': 'CCI equal or higher than 2 COTE equal or higher than 4 COMCOLD equal or higher than 4', 'interventionNames': ['Other: Frequency of AECOPD']}, {'label': 'Low comorbidity group', 'description': 'CCI lower than 2 COTE lower than 4 COMCOLD lower than 4', 'interventionNames': ['Other: Frequency of AECOPD']}], 'interventions': [{'name': 'Frequency of AECOPD', 'type': 'OTHER', 'description': 'No intervention has been applied. 92 COPD patients divided into 2 groups according to their comorbidity level. Than these groups were compared for their AECOPD frequency', 'armGroupLabels': ['High comorbidity group', 'Low comorbidity group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara University Faculty of Medicine', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'University Lecturer', 'investigatorFullName': 'Deniz Doğan Mülazimoğlu', 'investigatorAffiliation': 'Ankara University'}}}}