Ignite Creation Date:
2025-12-25 @ 12:52 AM
Ignite Modification Date:
2025-12-25 @ 11:07 PM
Study NCT ID:
NCT00393367
Status:
COMPLETED
Last Update Posted:
2012-08-10
First Post:
2006-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Budesonide Inhalation Suspension for Acute Asthma in Children
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': 'D000420', 'term': 'Albuterol'}, {'id': 'D019819', 'term': 'Budesonide'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D009241', 'term': 'Ipratropium'}], 'ancestors': [{'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': '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': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'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': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mollenc@email.chop.edu', 'phone': '215-590-4410', 'title': 'Cynthia J. Mollen', 'organization': "The Children's Hospital of Philadelphia"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '30 days', 'eventGroups': [{'id': 'EG000', 'title': 'Budesonide Inhalation Suspension (BIS)', 'description': 'standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)', 'otherNumAtRisk': 91, 'otherNumAffected': 30, 'seriousNumAtRisk': 91, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Placebo (Saline)', 'description': 'standardized treatment with nebulized saline', 'otherNumAtRisk': 91, 'otherNumAffected': 27, 'seriousNumAtRisk': 88, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'rhinorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'emesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'stomach ache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'leg pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospitalization within 5 days of Emergency Department discharge home', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased level of care', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Median Change in Asthma Score 2 Hours After Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide Inhalation Suspension (BIS)'}, {'id': 'OG001', 'title': 'Placebo (Normal Saline)'}], 'classes': [{'categories': [{'measurements': [{'value': '-3', 'groupId': 'OG000', 'lowerLimit': '-8', 'upperLimit': '2'}, {'value': '-3', 'groupId': 'OG001', 'lowerLimit': '-8', 'upperLimit': '3'}]}]}], 'analyses': [{'pValue': '0.44', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The difference in median improvement between treatment groups was expected to be greater than 2.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator', 'description': 'The scale used is the Asthma Score published by Qureshi et al. The Asthma Score ranges from a low of 5 to maximum of 15 points. One to 3 points are given for each of 5 categories: age-based respiratory rate, oxygen saturation, wheeze, retractions, and dyspnea. For category detalails, please see the Qureshi reference. Scores of 5-7 are considered mild, 8-11 moderate, and 12-15 severe. Asthma Scores are recorded prior to any intervention and at 2 hours after budesonide inhalation suspension/albuterol intervention or saline placebo/albuterol comparator.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '88 of the 91 patients randomized to budesonide were evaluable for the primary outcome (1 was discharged home, 1 had no 2 hour score, and 1 did not have a valid initial score). 81 of the 89 patients randomized to placebo were evaluable (1 inadvertently received standard therapy, 2 withdrew, and 5 were admitted before a 2 hour score evaluation).', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Number of Patients Hospitalized', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide Inhalation Suspension (BIS)', 'description': 'standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)'}, {'id': 'OG001', 'title': 'Placebo (Saline)', 'description': 'standardized treatment with nebulized saline'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.97', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.14', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'within 4 hours after the budesonide/albuterol intervention or saline/albuterol placebo', 'description': 'The number of patients requiring hospital admission 4 hours after budesonide/albuterol intervention or saline/albuterol comparator. All hospitalization decisions are made at the discretion of the attending physician.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Mean Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide Inhalation Suspension (BIS)'}, {'id': 'OG001', 'title': 'Placebo (Normal Saline)'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '17'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '17'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1', 'ciLowerLimit': '-7', 'ciUpperLimit': '6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'From the initial heart rate to heart rate 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator', 'description': 'Mean of heart rate in beats per minute before treatment minus mean of heart rate 2 hours after treatment with either budesonide/albuterol or saline/albuterol', 'unitOfMeasure': 'Beats per minute', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2010-06'}, {'type': 'SECONDARY', 'title': 'Mean Change in Respiratory Rate.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide Inhalation Suspension (BIS)'}, {'id': 'OG001', 'title': 'Placebo (Normal Saline)'}], 'classes': [{'categories': [{'measurements': [{'value': '-6', 'groupId': 'OG000', 'lowerLimit': '-8', 'upperLimit': '-3'}, {'value': '-6', 'groupId': 'OG001', 'lowerLimit': '-8', 'upperLimit': '-4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-3', 'ciUpperLimit': '3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.6', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Initial rate, minus rate taken 2 hours after budesonide/albuterol intervention or saline/albuterol comparator', 'description': 'Mean respiratory rate in breaths per minute before treatment minus respiratory rate 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator.', 'unitOfMeasure': 'Breaths per minute', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2010-06'}, {'type': 'SECONDARY', 'title': 'Oxygen Saturation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide Inhalation Suspension (BIS)'}, {'id': 'OG001', 'title': 'Placebo (Normal Saline)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '1.6'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '1.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-1', 'ciUpperLimit': '1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '.49', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator', 'description': 'Mean oxygen saturation (non-invasive pulse-oximetry, % hemoglobin saturation) 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator minus mean oxygen saturation before treatment.', 'unitOfMeasure': 'Percent Hemoglobin Saturation', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2010-06'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Remaining in the Severe Asthma Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide Inhalation Suspension (BIS)'}, {'id': 'OG001', 'title': 'Placebo (Normal Saline)'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.69', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.14', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator', 'description': 'Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who remained in this category 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of patients who presented in the severe asthma category (Asthma Score 12-15) who remained in that category 2 hours after either the intervention with budesonide/albuterol or saline/albuterol comparator.', 'anticipatedPostingDate': '2010-06'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Moving From the Severe Asthma to Moderate Asthma Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide Inhalation Suspension (BIS)'}, {'id': 'OG001', 'title': 'Placebo (Normal Saline)'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.22', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '0.47', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator', 'description': 'Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who moved to the moderate category (Asthma Severity score 8-11) 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of patients who presented in the severe asthma category (Asthma Score 12-15) who moved to the moderate asthma category (Asthma Score 8-11) 2 hours after either the intervention with budesonide/albuterol or saline/albuterol comparator.', 'anticipatedPostingDate': '2010-06'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Moving From the Severe Asthma to Mild Asthma Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide Inhalation Suspension (BIS)'}, {'id': 'OG001', 'title': 'Placebo (Normal Saline)'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.22', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '0.08', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator', 'description': 'Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who moved to the mild category (Asthma Severity score 5-7) 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of patients who presented in the severe asthma category (Asthma Score 12-15) who moved to the moderate asthma category (Asthma Score 8-11) 2 hours after either the intervention with budesonide/albuterol or saline/albuterol comparator.', 'anticipatedPostingDate': '2010-06'}, {'type': 'SECONDARY', 'title': 'Relapse / Readmission Numbers.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide Inhalation Suspension (BIS)'}, {'id': 'OG001', 'title': 'Placebo (Normal Saline)'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 5 days of ED visit', 'description': 'Participants admitted to the hospital within 5 days of the ED visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '89 of the 91 patients randomized to BIS were available for follow-up. 85 of the 89 patients randomized to placebo were available.'}, {'type': 'PRIMARY', 'title': 'Mean Change in Asthma Score at 2 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide Inhalation Suspension (BIS)'}, {'id': 'OG001', 'title': 'Placebo (Normal Saline)'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.9', 'groupId': 'OG000', 'lowerLimit': '-3.4', 'upperLimit': '-2.4'}, {'value': '-3.0', 'groupId': 'OG001', 'lowerLimit': '-3.5', 'upperLimit': '-2.5'}]}]}], 'analyses': [{'pValue': '0.78', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.36', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator', 'description': 'The scale used is the Asthma Score published by Qureshi et al. The Asthma Score ranges from a low of 5 to maximum of 15 points. One to 3 points are given for each of 5 categories: age-based respiratory rate, oxygen saturation, wheeze, retractions, and dyspnea. For category detalails, please see the Qureshi reference. Scores of 5-7 are considered mild, 8-11 moderate, and 12-15 severe. Asthma Scores are recorded prior to any intervention and at 2 hours after budesonide inhalation suspension/albuterol intervention or saline placebo/albuterol comparator.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '88 of the 91 patients randomized to budesonide were evaluable for the primary outcome (1 was discharged home, 1 had no 2 hour score, and 1 did not have a valid initial score). 81 of the 89 patients randomized to placebo were evaluable (1 inadvertently received standard therapy, 2 withdrew, and 5 were admitted before a 2 hour score evaluation).', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (Non-serious).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide Inhalation Suspension (BIS)'}, {'id': 'OG001', 'title': 'Placebo (Normal Saline)'}], 'classes': [{'title': 'Rhinorrhea', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Sore throat', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Cough', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Hyperglycemia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 30 days of the ED visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 180 patients randomized, 91 were to BIS, 89 were to placebo. Two patients were lost to follow-up in the BIS group and 4 in the placebo group.', 'anticipatedPostingDate': '2010-03'}, {'type': 'SECONDARY', 'title': 'Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide Inhalation Suspension (BIS)', 'description': 'standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)'}, {'id': 'OG001', 'title': 'Placebo (Saline)', 'description': 'standardized treatment with nebulized saline'}], 'classes': [{'title': 'Return within 5 days with hosptial admission', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Increased level of care', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-5 days', 'description': 'Serious Adverse Events', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '89 of the 91 patients randomized to BIS were available for follow-up. 85 of the 89 patients randomized to placebo were available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Budesonide Inhalation Suspension (BIS)', 'description': 'standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)'}, {'id': 'FG001', 'title': 'Placebo (Saline)', 'description': 'standardized treatment with nebulized saline'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Budesonide Inhalation Suspension (BIS)', 'description': 'standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)'}, {'id': 'BG001', 'title': 'Placebo (Saline)', 'description': 'standardized treatment with nebulized saline'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '3.9', 'groupId': 'BG000'}, {'value': '6.3', 'spread': '4.0', 'groupId': 'BG001'}, {'value': '6.2', 'spread': '4.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 179}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-06', 'studyFirstSubmitDate': '2006-10-25', 'resultsFirstSubmitDate': '2010-04-09', 'studyFirstSubmitQcDate': '2006-10-25', 'lastUpdatePostDateStruct': {'date': '2012-08-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-06-24', 'studyFirstPostDateStruct': {'date': '2006-10-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median Change in Asthma Score 2 Hours After Intervention', 'timeFrame': 'Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator', 'description': 'The scale used is the Asthma Score published by Qureshi et al. The Asthma Score ranges from a low of 5 to maximum of 15 points. One to 3 points are given for each of 5 categories: age-based respiratory rate, oxygen saturation, wheeze, retractions, and dyspnea. For category detalails, please see the Qureshi reference. Scores of 5-7 are considered mild, 8-11 moderate, and 12-15 severe. Asthma Scores are recorded prior to any intervention and at 2 hours after budesonide inhalation suspension/albuterol intervention or saline placebo/albuterol comparator.'}, {'measure': 'Mean Change in Asthma Score at 2 Hours', 'timeFrame': 'Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator', 'description': 'The scale used is the Asthma Score published by Qureshi et al. The Asthma Score ranges from a low of 5 to maximum of 15 points. One to 3 points are given for each of 5 categories: age-based respiratory rate, oxygen saturation, wheeze, retractions, and dyspnea. For category detalails, please see the Qureshi reference. Scores of 5-7 are considered mild, 8-11 moderate, and 12-15 severe. Asthma Scores are recorded prior to any intervention and at 2 hours after budesonide inhalation suspension/albuterol intervention or saline placebo/albuterol comparator.'}], 'secondaryOutcomes': [{'measure': 'Number of Patients Hospitalized', 'timeFrame': 'within 4 hours after the budesonide/albuterol intervention or saline/albuterol placebo', 'description': 'The number of patients requiring hospital admission 4 hours after budesonide/albuterol intervention or saline/albuterol comparator. All hospitalization decisions are made at the discretion of the attending physician.'}, {'measure': 'Change in Mean Heart Rate', 'timeFrame': 'From the initial heart rate to heart rate 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator', 'description': 'Mean of heart rate in beats per minute before treatment minus mean of heart rate 2 hours after treatment with either budesonide/albuterol or saline/albuterol'}, {'measure': 'Mean Change in Respiratory Rate.', 'timeFrame': 'Initial rate, minus rate taken 2 hours after budesonide/albuterol intervention or saline/albuterol comparator', 'description': 'Mean respiratory rate in breaths per minute before treatment minus respiratory rate 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator.'}, {'measure': 'Oxygen Saturation.', 'timeFrame': '2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator', 'description': 'Mean oxygen saturation (non-invasive pulse-oximetry, % hemoglobin saturation) 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator minus mean oxygen saturation before treatment.'}, {'measure': 'Number of Subjects Remaining in the Severe Asthma Category', 'timeFrame': 'From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator', 'description': 'Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who remained in this category 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator.'}, {'measure': 'Number of Subjects Moving From the Severe Asthma to Moderate Asthma Category', 'timeFrame': 'From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator', 'description': 'Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who moved to the moderate category (Asthma Severity score 8-11) 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator.'}, {'measure': 'Number of Subjects Moving From the Severe Asthma to Mild Asthma Category', 'timeFrame': 'From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator', 'description': 'Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who moved to the mild category (Asthma Severity score 5-7) 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator.'}, {'measure': 'Relapse / Readmission Numbers.', 'timeFrame': 'within 5 days of ED visit', 'description': 'Participants admitted to the hospital within 5 days of the ED visit'}, {'measure': 'Number of Participants With Adverse Events (Non-serious).', 'timeFrame': 'within 30 days of the ED visit'}, {'measure': 'Serious Adverse Events', 'timeFrame': '0-5 days', 'description': 'Serious Adverse Events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma', 'Acute', 'Treatment', 'Children', 'Pediatric', 'Inhaled corticosteroid', 'Budesonide', 'Budesonide inhalation suspension', 'Asthma score', 'Emergency', 'Emergency Department', 'Asthma flare', 'Clinical trial', 'Randomized clinical trial', 'Randomized trial', 'Pulmonary index score', 'Hospitalization', 'Moderate asthma', 'Severe asthma', 'Mixing budesonide', 'Budesonide admixture', 'Albuterol', 'Continuous albuterol', 'Ipratropium bromide'], 'conditions': ['Asthma', 'Acute Asthma', 'Reactive Airway Exacerbation']}, 'referencesModule': {'references': [{'pmid': '12917930', 'type': 'BACKGROUND', 'citation': 'Edmonds ML, Camargo CA Jr, Pollack CV Jr, Rowe BH. Early use of inhaled corticosteroids in the emergency department treatment of acute asthma. Cochrane Database Syst Rev. 2003;(3):CD002308. doi: 10.1002/14651858.CD002308.'}, {'pmid': '9761804', 'type': 'BACKGROUND', 'citation': 'Qureshi F, Pestian J, Davis P, Zaritsky A. Effect of nebulized ipratropium on the hospitalization rates of children with asthma. N Engl J Med. 1998 Oct 8;339(15):1030-5. doi: 10.1056/NEJM199810083391503.'}, {'pmid': '9523927', 'type': 'BACKGROUND', 'citation': 'Sung L, Osmond MH, Klassen TP. Randomized, controlled trial of inhaled budesonide as an adjunct to oral prednisone in acute asthma. Acad Emerg Med. 1998 Mar;5(3):209-13. doi: 10.1111/j.1553-2712.1998.tb02614.x.'}, {'pmid': '10503681', 'type': 'BACKGROUND', 'citation': 'Devidayal, Singhi S, Kumar L, Jayshree M. Efficacy of nebulized budesonide compared to oral prednisolone in acute bronchial asthma. Acta Paediatr. 1999 Aug;88(8):835-40. doi: 10.1080/08035259950168748.'}, {'pmid': '7574132', 'type': 'BACKGROUND', 'citation': 'Scarfone RJ, Loiselle JM, Wiley JF 2nd, Decker JM, Henretig FM, Joffe MD. Nebulized dexamethasone versus oral prednisone in the emergency treatment of asthmatic children. Ann Emerg Med. 1995 Oct;26(4):480-6. doi: 10.1016/s0196-0644(95)70118-4.'}, {'pmid': '16261956', 'type': 'BACKGROUND', 'citation': 'Nuhoglu Y, Atas E, Nuhoglu C, Iscan M, Ozcay S. Acute effect of nebulized budesonide in asthmatic children. J Investig Allergol Clin Immunol. 2005;15(3):197-200.'}, {'pmid': '10974132', 'type': 'BACKGROUND', 'citation': 'Schuh S, Reisman J, Alshehri M, Dupuis A, Corey M, Arseneault R, Alothman G, Tennis O, Canny G. A comparison of inhaled fluticasone and oral prednisone for children with severe acute asthma. N Engl J Med. 2000 Sep 7;343(10):689-94. doi: 10.1056/NEJM200009073431003.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the addition of budesonide inhalation suspension (BIS) to the standard therapy of albuterol, ipratropium bromide, and systemic corticosteroids (SCS) for moderate to severe asthma flares in children reduces asthma severity more rapidly than standard therapy alone.', 'detailedDescription': "Context: Acute asthma is a leading cause of emergency department (ED) visits and hospitalizations. Although standard therapy for acute asthma includes systemic corticosteroids (SCS), these drugs take many hours to have an effect. Recent studies demonstrate that inhaled corticosteroids (ICS) may improve patients' asthma severity more rapidly than SCS and may decrease hospitalizations. Only a few small studies have evaluated ICS added to standard therapy for acute asthma in children.\n\nObjective: To determine if adding the nebulized steroid budesonide to standard therapy including SCS improves patients' asthma severity faster than standard therapy alone and leads to fewer hospitalizations.\n\nStudy Design/Setting/Participants: A double-blind, randomized, controlled trial of budesonide inhalation suspension (BIS) versus placebo for children 2 to 18 years of age who present to a tertiary care, urban pediatric ED with a moderate to severe asthma flare.\n\nIntervention: Participants will receive standard therapy including SCS, albuterol, and ipratropium bromide and will be randomly assigned to also receive either nebulized BIS or saline.\n\nStudy Measures: Differences in asthma scores, vital signs, and the need for hospitalization will be compared between treatment groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chief complaint of "respiratory distress", "asthma", "trouble breathing", or "reactive airway disease"\n* Males or females age 2 to 18 years\n* Weight greater than or equal to 10 kilograms\n* Two or more prior Emergency Department or primary care visits for asthma or reactive airway disease\n* Identified in triage as either "acute" or "critical"\n* Asthma score of 8 or greater\n* Systemic corticosteroid prescribed in the Emergency Department\n* English-speaking parent/guardian present\n* Parental/guardian permission (informed consent) and if appropriate, child assent\n\nExclusion Criteria:\n\n* Systemic corticosteroid use in the last 30 days\n* Chronic lung diseases including cystic fibrosis\n* Sickle cell anemia\n* Immunodeficiency\n* Cardiac disease requiring surgery or medications\n* Adverse drug reaction or allergy to budesonide, albuterol, ipratropium bromide, prednisone, prednisolone, or methylprednisolone\n* Known renal or hepatic dysfunction\n* Exposure to varicella in the last 21 days\n* Impending respiratory failure requiring positive pressure ventilation\n* Altered level of consciousness\n* Suspected foreign body aspiration or croup\n* Prior enrollment in the study'}, 'identificationModule': {'nctId': 'NCT00393367', 'briefTitle': 'Budesonide Inhalation Suspension for Acute Asthma in Children', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Philadelphia"}, 'officialTitle': 'Budesonide Inhalation Suspension for Acute Asthma in Children', 'orgStudyIdInfo': {'id': '2006-8-4875'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Saline Placebo', 'description': 'All subjects will receive 3 albuterol sulfate doses, 2 ipratropium bromide doses, and systemic corticosteroids. All patients will receive both the systemic corticosteroids and one dose of a mixture of albuterol and ipratropium bromide while guardians are approached for consent. Patients randomized to this placebo comparator arm will then receive 2 nebulized albuterol doses mixed with 8mL of normal saline. Finally, all patients will receive the second nebulized ipratropium dose.', 'interventionNames': ['Drug: Prednisolone, prednisone, or methylprednisolone', 'Drug: Albuterol, ipratropium bromide', 'Drug: Ipratropium bromide']}, {'type': 'EXPERIMENTAL', 'label': 'Budesonide Inhalaiton Suspension', 'description': 'All subjects will receive 3 albuterol sulfate doses, 2 ipratropium bromide doses, and systemic corticosteroids. All patients will receive both the systemic corticosteroids and one dose of a mixture of albuterol and ipratropium bromide while guardians are approached for consent. Patients randomized to this intervention arm will then receive 2 nebulized albuterol doses mixed with 8mL of budesonide inhalation suspension (BIS). Finally, all patients will receive the second nebulized ipratropium dose.', 'interventionNames': ['Drug: Budesonide inhalation suspension (0.5 mg/2mL) 2mg, albuterol (5mg/mL) 7.5 or 10mg', 'Drug: Prednisolone, prednisone, or methylprednisolone', 'Drug: Albuterol, ipratropium bromide', 'Drug: Ipratropium bromide']}], 'interventions': [{'name': 'Budesonide inhalation suspension (0.5 mg/2mL) 2mg, albuterol (5mg/mL) 7.5 or 10mg', 'type': 'DRUG', 'otherNames': ['Pulmicort', 'Albuterol'], 'description': 'Patients randomized to budesonide inhalation suspension (BIS) receive 2 nebulized albuterol sulfate (5mg/mL) doses (2mL =10mg for patients over 20kg, 1.5mL =7.5mg for patients 10-20kg) mixed with 8mL (2mg) of BIS(0.5mg/2mL). The albuterol sulfate and BIS mixture is delivered by a medium volume, high flow nebulizer (AirLife Mister FinityTM)with an oxygen flow rate of 8L/min via a tight-fitting face mask.', 'armGroupLabels': ['Budesonide Inhalaiton Suspension']}, {'name': 'Prednisolone, prednisone, or methylprednisolone', 'type': 'DRUG', 'otherNames': ['Prednisolone', 'prednisone', 'methylprednisolone'], 'description': 'All patients are given 2mg/kg of systemic corticosteroids (max 60mg). Patients who can tolerate pills are given oral prednisone, those who cannot are given oral prednisolone, and those who cannot tolerate oral medications are given IV methylprednisolone.', 'armGroupLabels': ['Budesonide Inhalaiton Suspension', 'Saline Placebo']}, {'name': 'Albuterol, ipratropium bromide', 'type': 'DRUG', 'otherNames': ['Albuterol', 'Atrovent'], 'description': 'While guardians are approached for possible participation, patients are given a single nebulized dose of albuterol sulfate (5mg/mL) mixed with ipratropium bromide (500mcg/2.5mL). Patients who weigh 10-20kg receive 3.75mg of albuterol. Patients over 20kg receive 5mg of albuterol. All patients receive 500mcg of ipratropium bromide. Albuterol sulfate and ipratropium bromide are delivered by a medium volume, high flow nebulizer (AirLife Mister FinityTM)with an oxygen flow rate of 8L/min via a tight-fitting face mask.', 'armGroupLabels': ['Budesonide Inhalaiton Suspension', 'Saline Placebo']}, {'name': 'Ipratropium bromide', 'type': 'DRUG', 'otherNames': ['Atrovent'], 'description': '500 mcg/2.5mL. All patients receive a final dose of ipratropium bromide after the intervention or placebo. The ipratropium bromide is delivered by a medium volume, high flow nebulizer (AirLife Mister FinityTM) with an oxygen flow rate of 8L/minute via a tight-fitting face mask.', 'armGroupLabels': ['Budesonide Inhalaiton Suspension', 'Saline Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia Emergency Department", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Cynthia J Mollen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia"}, {'name': 'Bryan D. Upham, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': "University of New Mexico Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}