Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-28 @ 1:25 PM
Study NCT ID:
NCT01353235
Status:
COMPLETED
Last Update Posted:
2017-08-01
First Post:
2011-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Prednisolone in Severe Acute Exacerbation 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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 317}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-31', 'studyFirstSubmitDate': '2011-05-10', 'studyFirstSubmitQcDate': '2011-05-12', 'lastUpdatePostDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ICU mortality rate', 'timeFrame': 'ICU stay (on average patients will be followed 30 days)'}], 'secondaryOutcomes': [{'measure': 'Length of MV (and ventilatory free days)', 'timeFrame': 'ICU stay (on average patients will be followed 30 days)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD', 'acute respiratory failure', 'mechanical ventilation', 'non invasive ventilation', 'steroids'], 'conditions': ['COPD Exacerbation']}, 'referencesModule': {'references': [{'pmid': '20940378', 'type': 'BACKGROUND', 'citation': 'Chang KC, Leung CC, Kong FY. Corticosteroid administration and treatment failure in acute exacerbation of chronic obstructive pulmonary disease. JAMA. 2010 Oct 13;304(14):1554; author reply 1554-6. doi: 10.1001/jama.2010.1438. No abstract available.'}, {'pmid': '19532028', 'type': 'BACKGROUND', 'citation': 'Gunen H, Mirici A, Meral M, Akgun M. Steroids in acute exacerbations of chronic obstructive pulmonary disease: are nebulized and systemic forms comparable? Curr Opin Pulm Med. 2009 Mar;15(2):133-7. doi: 10.1097/MCP.0b013e32832185da.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of systematic administration of oral prednisolone (1mg/Kg/day) as an add on therapy in Chronic Obstructive Pulmonary Disease (COPD) patients admitted to intensive care unit (ICU) for severe exacerbation of COPD. Patients with pneumonia are excluded.\n\nRandomization is stratified according to ventilatory support: non invasive or conventional ventilation.The major outcome is the ICU mortality rate in overall population and stratified according to ventilatory mode (noninvasive ventilation (NIV) versus conventional).\n\nSecondary outcomes are superinfection necessitating a new antibiotic course, Length of mechanical ventilation (MV) (and ventilatory free days), Length of ICU stay, The frequency of gastric bleeding episodes that of frequency of hyperglycemic episodes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All COPD patients (according to the ATS definition) experiencing acute exacerbation originating in acute respiratory failure and requiring ICU admission will be included in the study.\n\nCOPD exacerbation is defined by the increased frequency of cough, volume and purulence of sputum and that of wheeze.\n\nAcute respiratory failure is defined by the presence of hypercapnia with PaCO2 \\>45mmHg associated with pH \\> 7.35 and signs of respiratory muscle fatigue (contraction of accessory respiratory muscles, thoracoabdominal swinging ,..).\n\nExclusion Criteria:\n\n* Asthmatic patients defined by a reversible obstructive disease following nebulized bronchodilators,\n* Patients with uncontrolled left heart failure,\n* AECOPD patients with a radiologically documented pneumonia,\n* Systemic corticotherapy within 30 days before screening,\n* contra-indication to corticosteroids (active gastroduodenal ulcer, uncontrolled sepsis, etc. ..)'}, 'identificationModule': {'nctId': 'NCT01353235', 'briefTitle': 'Oral Prednisolone in Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital Universitaire Fattouma Bourguiba'}, 'officialTitle': 'A Prospective Randomized Trial of Systemic Corticosteroids (Oral Prednisolone) in Severe Exacerbation of COPD Requiring Ventilatory Assistance', 'orgStudyIdInfo': {'id': 'steroids in COPD exacerbation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'usual care', 'interventionNames': ['Drug: usual care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prednisolone', 'description': '1mg/kg/day prednisolone for the entire ICU stay and a maximum of 10 days', 'interventionNames': ['Drug: Prednisolone']}], 'interventions': [{'name': 'Prednisolone', 'type': 'DRUG', 'description': 'Patients assigned to corticotherapy arm, will receive oral prednisolone 1mg/kg/j as an add on therapy for a maximum of 10 days.', 'armGroupLabels': ['Prednisolone']}, {'name': 'usual care', 'type': 'DRUG', 'description': 'no drug administered', 'armGroupLabels': ['usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Monastir', 'country': 'Tunisia', 'facility': 'CHU F.Bourguiba', 'geoPoint': {'lat': 35.77799, 'lon': 10.82617}}], 'overallOfficials': [{'name': 'Fekri Abroug, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU F.Bourguiba Monastir'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to IPD so far'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fekri Abroug', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'ead of the ICU', 'investigatorFullName': 'Fekri Abroug', 'investigatorAffiliation': 'Hôpital Universitaire Fattouma Bourguiba'}}}}