Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-04-04 @ 6:26 AM
Study NCT ID:
NCT00989833
Status:
COMPLETED
Last Update Posted:
2012-08-14
First Post:
2009-09-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparing Symbicort® As-Needed or Bricanyl As-Needed or Pulmicort® Once Daily + Bricanyl As-Needed in Asthma Patients
Sponsor:
Organization:
Raw JSON
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'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': 'D000068759', 'term': 'Formoterol Fumarate'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Budesonide/Terbutaline', 'description': 'Budesonide once daily and terbutaline before exercise and as needed', 'otherNumAtRisk': 21, 'otherNumAffected': 7, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Terbutaline', 'description': 'Placebo budesonide once daily and terbutaline before exercise and as needed', 'otherNumAtRisk': 22, 'otherNumAffected': 10, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Budesonide/Formoterol', 'description': 'Placebo budesonide once daily and budesonide/formoterol before exercise and as needed', 'otherNumAtRisk': 23, 'otherNumAffected': 9, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Common cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Slight Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide/Terbutaline', 'description': 'Budesonide once daily and terbutaline before exercise and as needed'}, {'id': 'OG001', 'title': 'Terbutaline', 'description': 'Placebo budesonide once daily and terbutaline before exercise and as needed'}, {'id': 'OG002', 'title': 'Budesonide/Formoterol', 'description': 'Placebo budesonide once daily and budesonide/formoterol before exercise and as needed'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.85', 'spread': '6.50', 'groupId': 'OG000'}, {'value': '0.61', 'spread': '10.92', 'groupId': 'OG001'}, {'value': '-5.24', 'spread': '9.64', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Visit 6', 'description': 'FEV1', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Maximum Post-exercise FEV1 Fall After 3 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide/Terbutaline', 'description': 'Budesonide once daily and terbutaline before exercise and as needed'}, {'id': 'OG001', 'title': 'Terbutaline', 'description': 'Placebo budesonide once daily and terbutaline before exercise and as needed'}, {'id': 'OG002', 'title': 'Budesonide/Formoterol', 'description': 'Placebo budesonide once daily and budesonide/formoterol before exercise and as needed'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.07', 'spread': '5.56', 'groupId': 'OG000'}, {'value': '-1.19', 'spread': '8.03', 'groupId': 'OG001'}, {'value': '-3.81', 'spread': '8.68', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 weeks', 'description': 'FEV1', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.'}, {'type': 'SECONDARY', 'title': 'Bronchial Responsiveness to Mannitol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide/Terbutaline', 'description': 'Budesonide once daily and terbutaline before exercise and as needed'}, {'id': 'OG001', 'title': 'Terbutaline', 'description': 'Placebo budesonide once daily and terbutaline before exercise and as needed'}, {'id': 'OG002', 'title': 'Budesonide/Formoterol', 'description': 'Placebo budesonide once daily and budesonide/formoterol before exercise and as needed'}], 'classes': [{'categories': [{'measurements': [{'value': '67.26', 'spread': '141.98', 'groupId': 'OG000'}, {'value': '-6.15', 'spread': '95.10', 'groupId': 'OG001'}, {'value': '151.87', 'spread': '141.09', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Change in cumulative Mannitol dose in mg in patients with a positive mannitol provocation test at baseline (PD15)', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.'}, {'type': 'SECONDARY', 'title': 'Concentration of Exhaled Nitric Oxide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide/Terbutaline', 'description': 'Budesonide once daily and terbutaline before exercise and as needed'}, {'id': 'OG001', 'title': 'Terbutaline', 'description': 'Placebo budesonide once daily and terbutaline before exercise and as needed'}, {'id': 'OG002', 'title': 'Budesonide/Formoterol', 'description': 'Placebo budesonide once daily and budesonide/formoterol before exercise and as needed'}], 'classes': [{'categories': [{'measurements': [{'value': '25.9', 'spread': '20.1', 'groupId': 'OG000'}, {'value': '35.5', 'spread': '36.6', 'groupId': 'OG001'}, {'value': '24.4', 'spread': '22.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'unitOfMeasure': 'ppb', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.'}, {'type': 'SECONDARY', 'title': 'Use of as Needed Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide/Terbutaline', 'description': 'Budesonide once daily and terbutaline before exercise and as needed'}, {'id': 'OG001', 'title': 'Terbutaline', 'description': 'Placebo budesonide once daily and terbutaline before exercise and as needed'}, {'id': 'OG002', 'title': 'Budesonide/Formoterol', 'description': 'Placebo budesonide once daily and budesonide/formoterol before exercise and as needed'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '0.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Mean number of as needed inhalations taken before exercise', 'unitOfMeasure': 'number of inhalations per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.'}, {'type': 'SECONDARY', 'title': 'Asthma Control Measured by a 5-item Asthma Control Questionnaire (ACQ5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide/Terbutaline', 'description': 'Budesonide once daily and terbutaline before exercise and as needed'}, {'id': 'OG001', 'title': 'Terbutaline', 'description': 'Placebo budesonide once daily and terbutaline before exercise and as needed'}, {'id': 'OG002', 'title': 'Budesonide/Formoterol', 'description': 'Placebo budesonide once daily and budesonide/formoterol before exercise and as needed'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '0.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline e and 6 weeks', 'description': 'Change in overall ACQ5. ACQ5 measures asthma control and a lower values shows a better asthma control, a higher value is worse. A decrease in the ACQ5 shows an improvement during the treatment period. Range of ACQ5 is 0-5, with 0 as the best value and 5 as the worst value. Further information at www.qoltech.co.uk.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.'}, {'type': 'SECONDARY', 'title': 'Diary Recording of Asthma Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide/Terbutaline', 'description': 'Budesonide once daily and terbutaline before exercise and as needed'}, {'id': 'OG001', 'title': 'Terbutaline', 'description': 'Placebo budesonide once daily and terbutaline before exercise and as needed'}, {'id': 'OG002', 'title': 'Budesonide/Formoterol', 'description': 'Placebo budesonide once daily and budesonide/formoterol before exercise and as needed'}], 'classes': [{'categories': [{'measurements': [{'value': '51.1', 'spread': '30.5', 'groupId': 'OG000'}, {'value': '50.9', 'spread': '36.6', 'groupId': 'OG001'}, {'value': '49.8', 'spread': '26.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Asthma symptoms during days with exercise', 'unitOfMeasure': 'Percent of exercise days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Adverse Event During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Budesonide/Terbutaline', 'description': 'Budesonide once daily and terbutaline before exercise and as needed'}, {'id': 'OG001', 'title': 'Terbutaline', 'description': 'Placebo budesonide once daily and terbutaline before exercise and as needed'}, {'id': 'OG002', 'title': 'Budesonide/Formoterol', 'description': 'Placebo budesonide once daily and budesonide/formoterol before exercise and as needed'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) comprises all randomized patients regardless of whether they took IP or not and for whom data had been recorded in the CRF after randomization.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Budesonide/Terbutaline', 'description': 'Budesonide once daily and terbutaline before exercise and as needed'}, {'id': 'FG001', 'title': 'Terbutaline', 'description': 'Placebo budesonide once daily and terbutaline before exercise and as needed'}, {'id': 'FG002', 'title': 'Budesonide/Formoterol', 'description': 'Placebo budesonide once daily and budesonide/formoterol before exercise and as needed'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Incorrectly randomized', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'On Visit 1, a total of 189 patients, aged 12-67, were enrolled at 10 study sites in 2 countries: Sweden and Norway. Of 189 enrolled patients, 66 patients were randomized and allocated to study treatment on Visit 3 (7 patients in Norway and 59 patients in Sweden).', 'preAssignmentDetails': 'A standardized exercise test (ECT) with duration of 6 minutes, at approximately 90% of maximal aerobic capacity (as defined on Visit 1) was performed on a treadmill while breathing dry air on Visit 2. Patients with exercised induced bronchoconstriction (defined as fall in FEV1 ≥ 10% ) could be randomized on Visit 3.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Budesonide/Terbutaline', 'description': 'Budesonide once daily and terbutaline before exercise and as needed'}, {'id': 'BG001', 'title': 'Terbutaline', 'description': 'Placebo budesonide once daily and terbutaline before exercise and as needed'}, {'id': 'BG002', 'title': 'Budesonide/Formoterol', 'description': 'Placebo budesonide once daily and budesonide/formoterol before exercise and as needed'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-06', 'studyFirstSubmitDate': '2009-09-30', 'resultsFirstSubmitDate': '2011-08-22', 'studyFirstSubmitQcDate': '2009-10-05', 'lastUpdatePostDateStruct': {'date': '2012-08-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-07-06', 'studyFirstPostDateStruct': {'date': '2009-10-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks', 'timeFrame': 'Baseline and Visit 6', 'description': 'FEV1'}], 'secondaryOutcomes': [{'measure': 'Percent Change in Maximum Post-exercise FEV1 Fall After 3 Weeks', 'timeFrame': 'Baseline and 3 weeks', 'description': 'FEV1'}, {'measure': 'Bronchial Responsiveness to Mannitol', 'timeFrame': 'Baseline and 6 weeks', 'description': 'Change in cumulative Mannitol dose in mg in patients with a positive mannitol provocation test at baseline (PD15)'}, {'measure': 'Concentration of Exhaled Nitric Oxide', 'timeFrame': '6 weeks'}, {'measure': 'Use of as Needed Medication', 'timeFrame': '6 weeks', 'description': 'Mean number of as needed inhalations taken before exercise'}, {'measure': 'Asthma Control Measured by a 5-item Asthma Control Questionnaire (ACQ5)', 'timeFrame': 'Baseline e and 6 weeks', 'description': 'Change in overall ACQ5. ACQ5 measures asthma control and a lower values shows a better asthma control, a higher value is worse. A decrease in the ACQ5 shows an improvement during the treatment period. Range of ACQ5 is 0-5, with 0 as the best value and 5 as the worst value. Further information at www.qoltech.co.uk.'}, {'measure': 'Diary Recording of Asthma Symptoms', 'timeFrame': '6 weeks', 'description': 'Asthma symptoms during days with exercise'}, {'measure': 'Number of Participants With an Adverse Event During the Study', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Exercise induced asthma', 'Mild intermittent asthma', 'Exercise induced bronchoconstriction'], 'conditions': ['Exercise Induced Asthma']}, 'referencesModule': {'references': [{'pmid': '24092567', 'type': 'DERIVED', 'citation': 'Lazarinis N, Jorgensen L, Ekstrom T, Bjermer L, Dahlen B, Pullerits T, Hedlin G, Carlsen KH, Larsson K. Combination of budesonide/formoterol on demand improves asthma control by reducing exercise-induced bronchoconstriction. Thorax. 2014 Feb;69(2):130-6. doi: 10.1136/thoraxjnl-2013-203557. Epub 2013 Oct 3.'}]}, 'descriptionModule': {'briefSummary': '1. The primary objective of this study is:\n\n * To evaluate the magnitude of the protective effect of the combination of budesonide and formoterol on an as-needed basis compared to the use of terbutaline as-needed on exercise induced bronchoconstriction in adults and adolescents with mild intermittent asthma\n2. The secondary objectives of this study are:\n\n * To evaluate the magnitude of the protective effect of the combination of budesonide and formoterol as-needed compared to regular once daily use of budesonide plus terbutaline as-needed on exercise induced bronchoconstriction in adults and adolescents with mild intermittent asthma\n * To evaluate safety of budesonide/formoterol as-needed, terbutaline as-needed and regular use of budesonide + terbutaline as-needed as terms of adverse event'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of exercise induced asthma\n* Maximum 4 asthmatic episodes per week requiring use of reliever medication\n\nExclusion Criteria:\n\n* No previous treatment with inhaled oral corticosteroids during the last month before randomisation\n* Suspected poor capability to follow instructions, ie to exercise 3-4 times a week'}, 'identificationModule': {'nctId': 'NCT00989833', 'acronym': 'MIA', 'briefTitle': 'Comparing Symbicort® As-Needed or Bricanyl As-Needed or Pulmicort® Once Daily + Bricanyl As-Needed in Asthma Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomised, Double Blind, Placebo Controlled, Parallel-group Study With Use of Budesonide/Formoterol "As-needed", or Terbutaline "As-needed" or Regular Use of Budesonide + Terbutaline "As-needed", in Patients With Mild Intermittent Asthma', 'orgStudyIdInfo': {'id': 'D5890L00032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'budesonide 400yg + terbutaline 0.4 mg as-needed', 'interventionNames': ['Drug: budesonide', 'Drug: terbutaline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'placebo + terbutaline 0.4 mg as-needed', 'interventionNames': ['Drug: terbutaline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C', 'description': 'placebo + budesonide/formoterol 160/4.5 yg as-needed', 'interventionNames': ['Drug: budesonide/formoterol']}], 'interventions': [{'name': 'budesonide', 'type': 'DRUG', 'otherNames': ['Pulmicort Turbuhaler'], 'description': '400 yg x 1', 'armGroupLabels': ['A']}, {'name': 'terbutaline', 'type': 'DRUG', 'otherNames': ['Bricanyl Turbuhaler'], 'description': '0.4 mg as-needed', 'armGroupLabels': ['A', 'B']}, {'name': 'budesonide/formoterol', 'type': 'DRUG', 'otherNames': ['Symbicort Turbuhaler'], 'description': '160/4.5 yg as-needed', 'armGroupLabels': ['C']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oslo', 'country': 'Norway', 'facility': 'Research Site', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Trondheim', 'country': 'Norway', 'facility': 'Research Site', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}, {'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Huddinge', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.23705, 'lon': 17.98192}}, {'city': 'Linköping', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'city': 'Luleå', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 65.58415, 'lon': 22.15465}}, {'city': 'Lund', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'city': 'Skene', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 57.48995, 'lon': 12.64196}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Kjell Larsson, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AstraZeneca MC Sweden'}, {'name': 'Georgios Stratelis', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca MC Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}