Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-02-03 @ 3:54 AM
Study NCT ID:
NCT02219360
Status:
UNKNOWN
Last Update Posted:
2014-08-18
First Post:
2014-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment in Patients Hospitalized With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '25-(OH)-VD3 and glycated albumin will be tested'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2015-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-08-15', 'studyFirstSubmitDate': '2014-07-09', 'studyFirstSubmitQcDate': '2014-08-15', 'lastUpdatePostDateStruct': {'date': '2014-08-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'percentage of use of systemic corticosteroid in patients', 'timeFrame': '8 months after the first enrollment'}], 'primaryOutcomes': [{'measure': 'change of the score of COPD Assesment Test as a measurement of the overall condition of the patient', 'timeFrame': 'baseline, 1 month after dischahge, 2 months after discharge'}], 'secondaryOutcomes': [{'measure': 'change of the score of modified Medical British Research Council questionaire as a measurement of the overall condition of the patient', 'timeFrame': 'baseline, 1 month after discharge, 2 months after discharge'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['acute', 'exacerbation', 'chronic obstructive pulmonary disease'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'Chronic obstructive pulmonary disease has become a serious global health care and public health problems due to its high prevalence, high morbidity and heavy economic burden. Acute exacerbation of chronic obstructive pulmonary disease is one of the most important causes of death in patients with COPD. Systemic corticosteroids therapy is recommended in COPD exacerbations. In clinical practice for the treatment of acute exacerbation of COPD， antibiotic application is still controversial. Evidence from current guideline is based on strict criteria from randomized controlled trials, thus the given condition is simplified. Patients meet the criteria account for the minority in the real world. Therefore, it is still not clear whether most patients benefit from the recommended treatment. In our design, hospitalized patients with acute exacerbation of COPD will be enrolled, with their treatment, arterial hypoxemia, recovery time and length of hospitalization being observed. The main purpose is to evaluate the benefit effect of current recommended treatment of acute exacerbation of COPD in the real world.', 'detailedDescription': 'Chronic obstructive pulmonary disease has become a serious global health care and public health problems due to its high prevalence, high morbidity and heavy economic burden. Acute exacerbation of COPD is one of the most important causes of death in patients with COPD. The global strategy for the diagnosis, management, and prevention of COPD recommends systemic corticosteroids therapy in COPD exacerbations as it can shorten recovery time, reduce treatment failure, improve lung function and arterial hypoxemia. In clinical practice for the treatment of acute exacerbation of COPD， antibiotic application is still controversial. Evidence from current guideline is based on strict criteria from randomized controlled trials, thus the given condition is simplified. Patients meet the criteria account for the minority in the real world. Therefore, it is still not clear whether most patients benefit from the recommended treatment. In our design, hospitalized patients with acute exacerbation of COPD will be enrolled, with their treatment, arterial hypoxemia, recovery time and length of hospitalization being observed. The main purpose is to evaluate the benefit effect of current recommended treatment of acute exacerbation of COPD in the real world.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized with acute exacerbation of chronic obstructive pulmonary disease from 1st July, 2014 from Beijing Chao Yang Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease\n* Age≥ 40years old\n\nExclusion Criteria:\n\n* The first diagnosis which caused hospitalization is not acute exacerbation of chronic obstructive pulmonary disease\n* Chest radiography shows congestive heart failure\n* Chest CT shows lung cancer, active pulmonary tuberculosis, pulmonary thromboembolism or interstitial lung diseases\n* Serious cardiac failure, renal insufficiency or hepatic dysfunction'}, 'identificationModule': {'nctId': 'NCT02219360', 'acronym': 'TripAE', 'briefTitle': 'Treatment in Patients Hospitalized With Acute Exacerbation of Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Chao Yang Hospital'}, 'officialTitle': 'Treatment in Patients Hospitalized With Acute Exacerbation of Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': '2014-K-115'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Huang Kewu, M.D.', 'role': 'CONTACT', 'email': 'kewuhuang@126.com', 'phone': '86-10-85231167'}, {'name': 'Wang Ying, Master', 'role': 'CONTACT', 'email': 'kokosalaki1020@gmail.com', 'phone': '86-0-13426121753'}], 'overallOfficials': [{'name': 'Wang Ying, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Chao Yang Hospital'}, {'name': 'Huang Kewu, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Beijing Chao Yang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Chao Yang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident', 'investigatorFullName': 'Wang Ying', 'investigatorAffiliation': 'Beijing Chao Yang Hospital'}}}}