Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-31 @ 9:25 PM
Study NCT ID:
NCT00588406
Status:
COMPLETED
Last Update Posted:
2016-01-21
First Post:
2007-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Budesonide as an Addition to Standard Therapy in Adult Asthmatics in the Emergency Room.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019819', 'term': 'Budesonide'}, {'id': 'D000420', 'term': 'Albuterol'}, {'id': 'D017265', 'term': 'Procaterol'}, {'id': 'D009241', 'term': 'Ipratropium'}, {'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D006912', 'term': 'Hydroxyquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001286', 'term': 'Atropine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D001533', 'term': 'Belladonna Alkaloids'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rsilverman@nshs.edu', 'phone': '718-470-7501', 'title': 'Dr. Robert Silverman', 'organization': 'North Shore Long Island Jewish Health System'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Budesonide', 'description': 'Budesonide, 2mg, 4 doses, plus standard care\n\nBudesonide: 2mg/dose by nebulizer, four doses over 3 hours\n\nalbuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours\n\nIpratropium bromide: 2.5 mg, one dose\n\nPrednisone: 60mg PO', 'otherNumAtRisk': 46, 'otherNumAffected': 0, 'seriousNumAtRisk': 46, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo plus standard care\n\nalbuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours\n\nIpratropium bromide: 2.5 mg, one dose\n\nPrednisone: 60mg PO', 'otherNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'FEV1 Percent Predicted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide', 'description': 'Budesonide, 2mg, 4 doses, plus standard care\n\nBudesonide: 2mg/dose by nebulizer, four doses over 3 hours\n\nalbuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours\n\nIpratropium bromide: 2.5 mg, one dose\n\nPrednisone: 60mg PO'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo plus standard care\n\nalbuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours\n\nIpratropium bromide: 2.5 mg, one dose\n\nPrednisone: 60mg PO'}], 'classes': [{'categories': [{'measurements': [{'value': '51.7', 'spread': '16.8', 'groupId': 'OG000'}, {'value': '52.6', 'spread': '15.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 hours post-randomization', 'unitOfMeasure': 'percent predicted of FEV1', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide', 'description': 'Budesonide, 2mg, 4 doses, plus standard care\n\nBudesonide: 2mg/dose by nebulizer, four doses over 3 hours\n\nalbuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours\n\nIpratropium bromide: 2.5 mg, one dose\n\nPrednisone: 60mg PO'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo plus standard care\n\nalbuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours\n\nIpratropium bromide: 2.5 mg, one dose\n\nPrednisone: 60mg PO'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 hours', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Budesonide', 'description': 'Budesonide, 2mg, 4 doses, plus standard care\n\nBudesonide: 2mg/dose by nebulizer, four doses over 3 hours\n\nalbuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours\n\nIpratropium bromide: 2.5 mg, one dose\n\nPrednisone: 60mg PO'}, {'id': 'FG001', 'title': 'Placob', 'description': 'Placebo plus standard care\n\nalbuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours\n\nIpratropium bromide: 2.5 mg, one dose\n\nPrednisone: 60mg PO'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Budesonide', 'description': 'Budesonide, 2mg, 4 doses, plus standard care\n\nBudesonide: 2mg/dose by nebulizer, four doses over 3 hours\n\nalbuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours\n\nIpratropium bromide: 2.5 mg, one dose\n\nPrednisone: 60mg PO'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo plus standard care\n\nalbuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours\n\nIpratropium bromide: 2.5 mg, one dose\n\nPrednisone: 60mg PO'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.2', 'spread': '11.4', 'groupId': 'BG000'}, {'value': '42.6', 'spread': '11.4', 'groupId': 'BG001'}, {'value': '40', 'spread': '11.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Forced expiratory volume at one second (FEV1) % predicted', 'classes': [{'categories': [{'measurements': [{'value': '29.5', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '29', 'spread': '8.1', 'groupId': 'BG001'}, {'value': '29.2', 'spread': '8.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent predicted of FEV1', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-15', 'studyFirstSubmitDate': '2007-12-21', 'resultsFirstSubmitDate': '2015-10-12', 'studyFirstSubmitQcDate': '2007-12-21', 'lastUpdatePostDateStruct': {'date': '2016-01-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-12-15', 'studyFirstPostDateStruct': {'date': '2008-01-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FEV1 Percent Predicted', 'timeFrame': '4 hours post-randomization'}], 'secondaryOutcomes': [{'measure': 'Hospitalization', 'timeFrame': '6 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['acute, emergency department'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'To determine whether adding nebulized inhaled steroids to the standard care of acutely ill ED patients with refractory acute asthma helps improve forced expiratory volume at one second (FEV1) and decrease the need for hospitalization.', 'detailedDescription': 'This is a randomized clinical trial studying the effect of nebulized budesonide (Pulmicort) in acutely ill adults presenting to the Emergency Department with severe asthma. Budesonide is an inhaled steroid FDA approved for the treatment of pediatric chronic asthma. ED entry criteria include hyporesponsiveness to nebulized beta-agonists and an FEV1\\<50% predicted. The trial will evaluate the efficacy of multiple doses of nebulized budesonide as an adjunct to a highly regimented standardized treatment protocol; standard care consists of bronchodilators (beta-agonists/anticholinergics), systemic steroids, and intravenous magnesium sulfate (if the FEV1\\<25% predicted). The primary efficacy endpoint will be the FEV1 4 hours after administration of the study intervention. An additional safety and efficacy endpoint will take place at 5 hours after study intervention. The treatments will be coupled with a protocol-defined assessment regimen, with endpoints measured before each treatment and on ED disposition (at 5 hours after study intervention).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* FEV1\\<50% predicted after bronchodilator therapy, age 18-60, presenting to an emergency department with acute asthma\n\nExclusion Criteria:\n\n* other chronic lung disease, \\>15 pack years smoking'}, 'identificationModule': {'nctId': 'NCT00588406', 'briefTitle': 'Study of Budesonide as an Addition to Standard Therapy in Adult Asthmatics in the Emergency Room.', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Emergency Department (ED) Use of Nebulized Budesonide as an Adjunct to Standardized Therapy in Acutely Ill Adults With Refractory Asthma: a Randomized, Double-blinded, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': '07.02.019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'Budesonide, 2mg, 4 doses, plus standard care', 'interventionNames': ['Drug: Budesonide', 'Drug: albuterol', 'Drug: Ipratropium bromide', 'Drug: Prednisone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'P', 'description': 'Placebo plus standard care', 'interventionNames': ['Drug: albuterol', 'Drug: Ipratropium bromide', 'Drug: Prednisone']}], 'interventions': [{'name': 'Budesonide', 'type': 'DRUG', 'otherNames': ['Pulmicort Respules'], 'description': '2mg/dose by nebulizer, four doses over 3 hours', 'armGroupLabels': ['B']}, {'name': 'albuterol', 'type': 'DRUG', 'otherNames': ['proventil', 'proair', 'ventolin', 'salbutamol'], 'description': '2.5mg/dose by nebulizer, 7 doses over 6 hours', 'armGroupLabels': ['B', 'P']}, {'name': 'Ipratropium bromide', 'type': 'DRUG', 'otherNames': ['Atrovent'], 'description': '2.5 mg, one dose', 'armGroupLabels': ['B', 'P']}, {'name': 'Prednisone', 'type': 'DRUG', 'otherNames': ['deltasone'], 'description': '60mg PO', 'armGroupLabels': ['B', 'P']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11554', 'city': 'East Meadow', 'state': 'New York', 'country': 'United States', 'facility': 'Nassau University Medical Center', 'geoPoint': {'lat': 40.71399, 'lon': -73.55902}}, {'zip': '11042', 'city': 'Queens', 'state': 'New York', 'country': 'United States', 'facility': 'Long Island Jewish Medical Center', 'geoPoint': {'lat': 40.68149, 'lon': -73.83652}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Jacobi Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Robert Silverman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwell Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}, {'name': 'Jacobi Medical Center', 'class': 'OTHER'}, {'name': 'Nassau University Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Robert A Silverman', 'investigatorAffiliation': 'Northwell Health'}}}}