Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-03-06 @ 2:18 AM
Study NCT ID:
NCT01944033
Status:
COMPLETED
Last Update Posted:
2018-01-26
First Post:
2013-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
β2-agonist Versus Ipratropium Bromide Associated With β2-agonists in Chronic Obstructive Pulmonary Disease Exacerbation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013726', 'term': 'Terbutaline'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-24', 'studyFirstSubmitDate': '2013-09-09', 'studyFirstSubmitQcDate': '2013-09-12', 'lastUpdatePostDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hospital admission rate and ICU admission rate', 'timeFrame': 'within 24 hours after ED admission'}], 'secondaryOutcomes': [{'measure': 'dyspnea score', 'timeFrame': '24 hours after ED admission'}, {'measure': 'endotracheal intubation rate', 'timeFrame': 'within 24 hours after ED admission'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['β2-agonist', 'Ipratropium Bromide', 'Chronic Obstructive Pulmonary Disease Exacerbation', 'Emergency departement'], 'conditions': ['Acute Exacerbation of Chronic Obstructive Airways Disease']}, 'descriptionModule': {'briefSummary': 'The effectiveness of β2-agonists in the treatment of exacerbations of COPD is already established. The purpose of this study is to compare the effectiveness of the β2-agonists alone in nebulization with the association β2-agonists + Ipratropium bromide in the treatment of an acute exacerbation of COPD consulting the emergency departement based on the clinical and arterial blood gas.', 'detailedDescription': 'It is a prospective study and randomized performed in patients admitted to the emergency departement for acute exacerbation of COPD. The patients were divided in two groups: Group Terbutaline/Ipratropium Bromide; received Terbutaline + Ipratropium bromide in nebulization and Group Terbutaline received Terbutaline alone in nebulization)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* have known or suspected COPD based on pulmonary function test, arterial blood gas, clinical history, physical examination, and chest radiograph\n* Age over 18 years old.\n* COPD Exacerbation: sustained worsening of patient's condition from stable state necessitating change in regular medication within the last two weeks and need for non invasive ventilation with regard to arterialo blood gas abnormalities: PaCO2 \\> 45 mmHg, PH\\<7,35 SaO2\\<90%\n\nExclusion Criteria:\n\n* GCS ≤ 14\n* hypersensitivity to anticholinergic\n* severe acidosis\n* immediate need for intubation\n* lack of patient cooperation\n* serious hemodynamic unstability or systolic blood pressure \\< 90 mmHg, heart arrhythmia"}, 'identificationModule': {'nctId': 'NCT01944033', 'briefTitle': 'β2-agonist Versus Ipratropium Bromide Associated With β2-agonists in Chronic Obstructive Pulmonary Disease Exacerbation', 'organization': {'class': 'OTHER', 'fullName': 'University of Monastir'}, 'officialTitle': 'β2-agonist Versus Ipratropium Bromide Associated With β2-agonists in Chronic Obstructive Pulmonary Disease Exacerbation', 'orgStudyIdInfo': {'id': 'β2-agonist'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group Terbutaline', 'description': 'Group Terbutaline received 5 mg Terbutaline sulfate (2ml) and 3ml serum saline in nebulization repeated three times during 1 hour and every 4 hours during the first 24 hour protocol', 'interventionNames': ['Drug: Bricanyl/Iprovent']}, {'type': 'EXPERIMENTAL', 'label': 'Group Terbutaline/IB', 'description': 'Group Terbutaline/Ipratropium Bromide received combination of 5 mg Terbutaline (2ml) and 0.5 mg Ipratropium bromide (2ml) and 1ml serum saline in nebulization repeated threeand every 4 hours during the first 24 hour protocol', 'interventionNames': ['Drug: Bricanyl']}], 'interventions': [{'name': 'Bricanyl/Iprovent', 'type': 'DRUG', 'description': '5 mg Terbutaline sulfate (2ml) + 0,5 mg Ipratropium bromide (2ml) + 1ml serum saline in each nebulization which is repeated three times during 1 hour and every 4 hours during the first 24 hour protocol', 'armGroupLabels': ['Group Terbutaline']}, {'name': 'Bricanyl', 'type': 'DRUG', 'description': '5 mg Terbutaline sulfate (2ml) + 3ml serum saline in each nebulization which is repeated three times during 1 hour and every 4 hours during the first 24 hour protocol', 'armGroupLabels': ['Group Terbutaline/IB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Monastir', 'state': 'Monastir Governorate', 'country': 'Tunisia', 'facility': 'University Hospital of Monastir', 'geoPoint': {'lat': 35.77799, 'lon': 10.82617}}, {'zip': '5000', 'city': 'Monastir', 'country': 'Tunisia', 'facility': 'Fattouma Bourguiba University Hospital', 'geoPoint': {'lat': 35.77799, 'lon': 10.82617}}], 'overallOfficials': [{'name': 'semir nouira, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Monastir'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Monastir', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Semir Nouira', 'investigatorFullName': 'Pr. Semir Nouira', 'investigatorAffiliation': 'University of Monastir'}}}}