Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2026-01-03 @ 11:07 PM
Study NCT ID:
NCT00311961
Status:
COMPLETED
Last Update Posted:
2009-08-26
First Post:
2006-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Versus Oral Administration of Prednisolone in Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
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': 'D011239', 'term': 'Prednisolone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 256}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2003-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-25', 'studyFirstSubmitDate': '2006-04-05', 'studyFirstSubmitQcDate': '2006-04-05', 'lastUpdatePostDateStruct': {'date': '2009-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment failure defined as: death from any cause'}, {'measure': 'admission to the intensive care unit'}, {'measure': 'readmission to the hospital because of COPD'}, {'measure': 'and the necessity to intensify pharmacologic treatment'}], 'secondaryOutcomes': [{'measure': 'Changes in forced expiratory volume in 1 second (FEV1)'}, {'measure': "St. George's Respiratory Questionnaire (SGRQ) scores"}, {'measure': 'Clinical COPD Questionnaire (CCQ) scores'}, {'measure': 'and length of hospital stay'}]}, 'conditionsModule': {'keywords': ['COPD', 'Exacerbations', 'Corticosteroids', 'Oral', 'Intravenous', 'Chronic Obstructive Pulmonary Disease (COPD)'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '17646228', 'type': 'DERIVED', 'citation': 'de Jong YP, Uil SM, Grotjohan HP, Postma DS, Kerstjens HA, van den Berg JW. Oral or IV prednisolone in the treatment of COPD exacerbations: a randomized, controlled, double-blind study. Chest. 2007 Dec;132(6):1741-7. doi: 10.1378/chest.07-0208. Epub 2007 Jul 23.'}]}, 'descriptionModule': {'briefSummary': 'Treatment with systemic corticosteroids for acute exacerbations of COPD results in the improvement of clinical outcomes. The optimal route of administration has not been rigorously studied in COPD. Upon hospitalization, corticosteroids are administered intravenously in many hospitals. Oral administration is more convenient, though, because there is no need for intravenous access, less personnel is required for starting and monitoring therapy, and material costs are smaller.\n\nThe investigators hypothesized that oral administration is not inferior to intravenous administration of prednisolone in the treatment of patients hospitalized for an acute exacerbation of COPD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Exacerbation of COPD (at least Global Initiative for Chronic Obstructive Lung Disease \\[GOLD\\] severity stage II)\n* Smoking history of \\> 10 pack years\n\nExclusion Criteria:\n\n* Signs of severe exacerbation (arterial pH \\< 7.26 or pCO2 \\> 9.3 kPa)\n* History of asthma\n* Significant or unstable co-morbidity\n* Participated in another study 4 weeks before admission\n* Previously randomized to this study\n* Findings on chest radiography other than those fitting with signs of COPD\n* Known hypersensitivity to prednisolone\n* Non-compliant'}, 'identificationModule': {'nctId': 'NCT00311961', 'briefTitle': 'Intravenous Versus Oral Administration of Prednisolone in Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'OTHER', 'fullName': 'Isala'}, 'officialTitle': 'A Comparison of Intravenous Versus Oral Administration of Prednisolone in the Treatment of Exacerbations of Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'IK-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Intravenous prednisolone', 'type': 'DRUG'}, {'name': 'Oral prednisolone', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000 GM', 'city': 'Zwolle', 'state': 'Overijssel', 'country': 'Netherlands', 'facility': 'Isala Klinieken', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}], 'overallOfficials': [{'name': 'Jan WK van den Berg, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Isala'}, {'name': 'Ynze P de Jong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Isala'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isala', 'class': 'OTHER'}}}}