Ignite Creation Date:
2025-12-25 @ 2:25 AM
Ignite Modification Date:
2026-02-25 @ 10:03 PM
Study NCT ID:
NCT02406534
Status:
WITHDRAWN
Last Update Posted:
2015-05-06
First Post:
2015-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective, Observational Study of COPD Patients in U.S. Hospitals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Study entered in error', 'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'lastUpdateSubmitDate': '2015-05-04', 'studyFirstSubmitDate': '2015-03-30', 'studyFirstSubmitQcDate': '2015-04-01', 'lastUpdatePostDateStruct': {'date': '2015-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'COPD related readmissions', 'timeFrame': '6 months'}, {'measure': 'Health related quality of life (HRQoL)', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'This is an observational study to evaluate the relationship between pulmonary function and the patient reported health-related quality of life (HRQoL) and chronic obstructive pulmonary disease (COPD) related admissions. Patients with COPD will be approached to participate in the study. Pulmonary function will be measured on consented, eligible patients. The pulmonary function measurement collected will be used for cohort assignment. The prospective follow up period will monitor the cohorts for evidence of readmission and to assess HRQoL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'COPD patients admitted for a COPD exacerbation.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n≥ 18 years of age Fluent in English Current hospital admission is for COPD Diagnosis of COPD for at least 1 year prior to enrollment\n\nExclusion Criteria:\n\nUnwilling or unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT02406534', 'briefTitle': 'A Prospective, Observational Study of COPD Patients in U.S. Hospitals', 'organization': {'class': 'OTHER', 'fullName': 'EPI-Q'}, 'orgStudyIdInfo': {'id': '000'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal Pulmonary Function', 'interventionNames': ['Behavioral: HRQoL surveys']}, {'label': 'Reduced Pulmonary Function', 'interventionNames': ['Behavioral: HRQoL surveys']}], 'interventions': [{'name': 'HRQoL surveys', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Normal Pulmonary Function', 'Reduced Pulmonary Function']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Valerie Caroselli', 'role': 'STUDY_DIRECTOR', 'affiliation': 'EPI-Q'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EPI-Q', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}