Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT00837967
Status:
COMPLETED
Last Update Posted:
2012-08-29
First Post:
2009-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Investigate the Safety and Efficacy of High Dose of Symbicort® SMART in Japanese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069502', 'term': 'Budesonide, Formoterol Fumarate Drug Combination'}], 'ancestors': [{'id': 'D000068759', 'term': 'Formoterol Fumarate'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D019819', 'term': 'Budesonide'}, {'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': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aztrial_results_posting@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Of 25 patients in safety analysis set, 2 patients did not receive terbutaline due to adverse events lead to discontinuation. Therefore, data from 25 patients for Symbicort and 23 patients for terbutaline were used for the safety evaluation.', 'eventGroups': [{'id': 'EG000', 'title': 'Symbicort', 'description': 'Symbicort Turbuhaler 160/4.5μg for 3 days', 'otherNumAtRisk': 25, 'otherNumAffected': 7, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Terbutaline', 'description': 'Terbutaline Turbuhaler 0.4 mg for 3 days', 'otherNumAtRisk': 23, 'otherNumAffected': 15, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Blood Pressure Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort', 'description': 'Symbicort Turbuhaler 160/4.5μg'}, {'id': 'OG001', 'title': 'Terbutaline', 'description': 'Terbutaline Turbuhaler 0.4 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 days', 'description': 'Total number of adverse events', 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Serum Potassium - Average Concentration From Trapezoidal Area Under the Curve (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort', 'description': 'Symbicort Turbuhaler 160/4.5μg'}, {'id': 'OG001', 'title': 'Terbutaline', 'description': 'Terbutaline Turbuhaler 0.4 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '4.01', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '3.88', 'spread': '0.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 740 min after start dosing for each treatment day', 'description': 'The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.', 'unitOfMeasure': 'mEq/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Blood Glucose - Average Concentration From Trapezoidal Area Under the Curve (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort', 'description': 'Symbicort Turbuhaler 160/4.5μg'}, {'id': 'OG001', 'title': 'Terbutaline', 'description': 'Terbutaline Turbuhaler 0.4 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '121.1', 'spread': '20.3', 'groupId': 'OG000'}, {'value': '129.5', 'spread': '22.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 140 min after start dosing for each treatment day', 'description': 'The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.', 'unitOfMeasure': 'mg/dLiters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Electrocardiogram (ECG)- Average Trapezoidal Area Under the Curve (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort', 'description': 'Symbicort Turbuhaler 160/4.5μg'}, {'id': 'OG001', 'title': 'Terbutaline', 'description': 'Terbutaline Turbuhaler 0.4 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '411.71', 'spread': '15.07', 'groupId': 'OG000'}, {'value': '414.33', 'spread': '14.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 740 min after start dosing for each treatment day', 'description': "The mean AUC of QTcF (ECG interval measured from the beginning of the Q wave to the end of the T wave, corrected for heart rate using Fridericia's formula)was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.", 'unitOfMeasure': 'ms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Vital Sign (Blood Pressure)- Average Trapezoidal Area Under the Curve (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort', 'description': 'Symbicort Turbuhaler 160/4.5μg'}, {'id': 'OG001', 'title': 'Terbutaline', 'description': 'Terbutaline Turbuhaler 0.4 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '115.3', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '114.9', 'spread': '8.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 740 min after start dosing for each treatment day', 'description': 'The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Vital Sign (Pulse Rate)- Average Trapezoidal Area Under the Curve (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symbicort', 'description': 'Symbicort Turbuhaler 160/4.5μg'}, {'id': 'OG001', 'title': 'Terbutaline', 'description': 'Terbutaline Turbuhaler 0.4 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '70.0', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '74.1', 'spread': '7.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 740 min after start dosing for each treatment day', 'description': 'The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.', 'unitOfMeasure': 'beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Symbicort First, Then Terbutaline', 'description': 'Symbicort Turbuhaler 160/4.5μg for 3 days First , then Terbutaline Turbuhaler 0.4 mg for 3 days'}, {'id': 'FG001', 'title': 'Terbutaline First, Then Symbicort', 'description': 'Terbutaline Turbuhaler 0.4 mg for 3 days First, then Symbicort Turbuhaler 160/4.5μg for 3 days,'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout Period of 7 - 14 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients recruited from 2 hospitals in Japan between January 2009 and July 2009. 28 patients enrolled; 25 patients randomized, 3 patients were not randomized (1 due to incorrect enrollment and 2 due to adverse event)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.3', 'spread': '14.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-27', 'studyFirstSubmitDate': '2009-02-05', 'resultsFirstSubmitDate': '2010-07-05', 'studyFirstSubmitQcDate': '2009-02-05', 'lastUpdatePostDateStruct': {'date': '2012-08-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-08-27', 'studyFirstPostDateStruct': {'date': '2009-02-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '3 days', 'description': 'Total number of adverse events'}, {'measure': 'Serum Potassium - Average Concentration From Trapezoidal Area Under the Curve (AUC)', 'timeFrame': 'up to 740 min after start dosing for each treatment day', 'description': 'The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.'}, {'measure': 'Blood Glucose - Average Concentration From Trapezoidal Area Under the Curve (AUC)', 'timeFrame': 'up to 140 min after start dosing for each treatment day', 'description': 'The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.'}, {'measure': 'Electrocardiogram (ECG)- Average Trapezoidal Area Under the Curve (AUC)', 'timeFrame': 'up to 740 min after start dosing for each treatment day', 'description': "The mean AUC of QTcF (ECG interval measured from the beginning of the Q wave to the end of the T wave, corrected for heart rate using Fridericia's formula)was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period."}, {'measure': 'Vital Sign (Blood Pressure)- Average Trapezoidal Area Under the Curve (AUC)', 'timeFrame': 'up to 740 min after start dosing for each treatment day', 'description': 'The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.'}, {'measure': 'Vital Sign (Pulse Rate)- Average Trapezoidal Area Under the Curve (AUC)', 'timeFrame': 'up to 740 min after start dosing for each treatment day', 'description': 'The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma', 'Symbicort Turbuhaler'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '22024920', 'type': 'DERIVED', 'citation': 'Saito T, Hasunuma T. Safety and tolerability of high-dose budesonide/formoterol via Turbuhaler(R) in Japanese patients with asthma: a randomized, double-blind, crossover, active comparator-controlled, phase III study. Clin Drug Investig. 2012 Jan 1;32(1):51-61. doi: 10.2165/11595440-000000000-00000.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to compare the tolerability of Symbicort® Turbuhaler® 160/4.5 μg 10 inhalations with terbutaline Turbuhaler® 0.4 mg 10 inhalations for 3 days on top of Symbicort® Turbuhaler® 160/4.5 μg 1 inhalation twice a day (bid) in adult asthma patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of informed consent prior to any study specific procedures\n* A minimum of 6 months documented history of asthma according to the JGL2006/GINA2006 definition\n* FEV1\\> 70% of predicted normal value pre-bronchodilator\n\nExclusion Criteria:\n\n* Having a known or suspected allergy to study therapy (active drugs or additive)\n* Having a known clinical history of hypertension, relevant arrhythmias or other heart disease, eg, ischemic heart disease, cardiomyopathy, valvular heart disease, or heart failure\n* Having been treated with oral, parenteral or rectal glucocorticoids within 4 weeks, or with depot parenteral glucocorticoids within 3 months\n* Respiratory infection significantly affecting the asthma, as judged by the investigator within 4 weeks'}, 'identificationModule': {'nctId': 'NCT00837967', 'briefTitle': 'Study to Investigate the Safety and Efficacy of High Dose of Symbicort® SMART in Japanese Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Comparison of Tolerability of 10 Inhalations of Symbicort® Turbuhaler® 160/4.5 μg and 10 Inhalations of Terbutaline Turbuhaler® 0.4 mg on Top of Symbicort® Turbuhaler® 160/4.5 μg 1 Inhalation Bid, Randomized, Double-blind, Cross Over, Phase III Study in Japanese Adults Asthma Patients', 'orgStudyIdInfo': {'id': 'D589LC00003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'First Symbicort, then Terbutaline', 'description': 'Symbicort Turbuhaler 160/4.5μg for 3 days First , then Terbutaline Turbuhaler 0.4 mg for 3 days', 'interventionNames': ['Drug: Symbicort Turbuhaler', 'Drug: Terbutaline Turbuhaler']}, {'type': 'EXPERIMENTAL', 'label': 'First Turbuhaler, then Symbicort', 'description': 'Terbutaline Turbuhaler 0.4 mg for 3 days First, then Symbicort Turbuhaler 160/4.5μg for 3 days,', 'interventionNames': ['Drug: Symbicort Turbuhaler', 'Drug: Terbutaline Turbuhaler']}], 'interventions': [{'name': 'Symbicort Turbuhaler', 'type': 'DRUG', 'description': '160/4.5μg for 3 days', 'armGroupLabels': ['First Symbicort, then Terbutaline', 'First Turbuhaler, then Symbicort']}, {'name': 'Terbutaline Turbuhaler', 'type': 'DRUG', 'description': '0.4 mg for 3 days', 'armGroupLabels': ['First Symbicort, then Terbutaline', 'First Turbuhaler, then Symbicort']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ibaraki', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.81641, 'lon': 135.56828}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Tomas Andersson, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca R&D Lund'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}