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'}, {'id': 'D019819', 'term': 'Budesonide'}, {'id': 'D000068759', 'term': 'Formoterol Fumarate'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'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}, 'limitationsAndCaveats': {'description': 'The study was prematurely stopped, because it was not possible to recruit the sample size required in the period of time established.'}}, 'adverseEventsModule': {'description': "The safety analysis set included 652 patients, because two patients in the Symbicort SMART arm were excluded from the safety analysis because they didn't take any dose of medication", 'eventGroups': [{'id': 'EG000', 'title': 'SMART', 'description': 'Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)', 'otherNumAtRisk': 326, 'otherNumAffected': 0, 'seriousNumAtRisk': 326, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Conv. Best Practice', 'description': "Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator's clinical judgement.", 'otherNumAtRisk': 326, 'otherNumAffected': 0, 'seriousNumAtRisk': 326, 'seriousNumAffected': 5}], 'seriousEvents': [{'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Uterine Leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Epicondylitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gene Mutation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Medullary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Irritable Bowel Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 326, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cerebral Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Bursitis Infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 326, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to First Severe Asthma Exacerbation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SMART', 'description': 'Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)'}, {'id': 'OG001', 'title': 'Conv. 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Best Practice', 'description': "Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator's clinical judgement."}], 'classes': [{'categories': [{'measurements': [{'value': '405.9', 'groupId': 'OG000', 'lowerLimit': '110', 'upperLimit': '900'}, {'value': '400.6', 'groupId': 'OG001', 'lowerLimit': '140', 'upperLimit': '900'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months (end of the study)', 'description': 'Peak expiratory flow (PEF)', 'unitOfMeasure': 'L/min', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SMART', 'description': 'Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)'}, {'id': 'FG001', 'title': 'Conv. Best Practice', 'description': "Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator's clinical judgement."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '328'}, {'groupId': 'FG001', 'numSubjects': '326'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '270'}, {'groupId': 'FG001', 'numSubjects': '289'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '37'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Several reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Incorrect inclusion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Incorrect randomization', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '654'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'BG000'}, {'value': '326', 'groupId': 'BG001'}, {'value': '654', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SMART', 'description': 'Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)'}, {'id': 'BG001', 'title': 'Conv. Best Practice', 'description': "Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator's clinical judgement."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.7', 'spread': '16.4', 'groupId': 'BG000'}, {'value': '44.3', 'spread': '16.5', 'groupId': 'BG001'}, {'value': '44.0', 'spread': '16.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '218', 'groupId': 'BG000'}, {'value': '202', 'groupId': 'BG001'}, {'value': '420', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 654}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-30', 'studyFirstSubmitDate': '2006-10-06', 'resultsFirstSubmitDate': '2009-10-14', 'studyFirstSubmitQcDate': '2006-10-06', 'lastUpdatePostDateStruct': {'date': '2010-12-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-10-14', 'studyFirstPostDateStruct': {'date': '2006-10-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-11-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to First Severe Asthma Exacerbation', 'timeFrame': 'Baseline up to 6 months', 'description': 'Severe asthma exacerbation is defined as deterioration in asthma leading to at least one of Hospitalization/Emergency room (or equivalent) treatment due to asthma or Oral Glucocorticosteroids (GCS) treatment for at least 3 days.'}], 'secondaryOutcomes': [{'measure': 'Total Number of Severe Exacerbations', 'timeFrame': 'Baseline up to 6 months', 'description': 'Severe asthma exacerbation is defined as deterioration in asthma leading to at least one of Hospitalization/Emergency room (or equivalent) treatment due to asthma or Oral (GCS) treatment for at least 3 days.'}, {'measure': 'Mean Use of as Needed Medication', 'timeFrame': 'Baseline up to 6 months', 'description': 'Mean use of as needed medication during the treatment period'}, {'measure': 'Use of Inhaled Steroids', 'timeFrame': 'Baseline up to 6 months', 'description': 'Mean micrograms/day of inhaled steroids (beclomethasone dipropionate equivalents)'}, {'measure': 'Change in the Asthma Control Questionnaire(ACQ) Score', 'timeFrame': 'Daily 14 days prior to each of visit 2-4', 'description': 'The ACQ is a 7-point scale with scores ranging from 0 (very well controlled) to 6 (very badly controlled)'}, {'measure': 'Peak Expiratory Flow (PEF)', 'timeFrame': '6 months (end of the study)', 'description': 'Peak expiratory flow (PEF)'}]}, 'conditionsModule': {'conditions': ['Asthma, Bronchial']}, 'descriptionModule': {'briefSummary': "This study is intended to extend the knowledge of Symbicort Single Inhaler Therapy into a more general setting in order to assess the real-life impact of introducing this new treatment concept. The study will compare the Symbicort Single Inhaler Therapy concept with a conventional stepwise treatment regimen according to the investigator's judgement in patients who present with symptoms on inhaled glucocorticosteroids (GCS) treatment or who require and are already on treatment with a combination of inhaled and long-acting B2 agonists (LABA)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition (9).\n* Prescribed inhaled GCS at a dose of 400μg/day of budesonide (or equivalents)and within the approved label for the relevant drug during the last 3 months prior to Visit 1.\n* Either daily maintenance treatment with both inhaled GCS and LABA or daily treatment with inhaled GCS alone (i.e. without LABA)\n* A history of suboptimal asthma control the month prior to enrolment as judged by the investigator\n* Use of ≥3 inhalations of as needed medication for symptom relief during the last 7 days before enrolment\n\nExclusion Criteria:\n\n* Previous treatment with Symbicort Single Inhaler;\n* Use of any b-blocking agent, including eye-drops and oral GCS as maintenance treatment.\n* Known or suspected hypersensitivity to study therapy or excipients.\n* A history of smoking ≥ 10 pack years.\n* Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to or at Visit 1.'}, 'identificationModule': {'nctId': 'NCT00385593', 'briefTitle': 'Symbicort Single Inhaler Therapy vs Conventional Best Practice for the Treatment of Persistent Asthma in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Comparison of Symbicort Single Inhaler Therapy (Symbicort Turbuhaler 160/4.5 Micrograms, 1 Inhalation b.i.d. Plus as Needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adults - a 26-week, Randomised, Open-label, Parallel-group, Multicentre Study. Study SPAIN', 'orgStudyIdInfo': {'id': 'D5890L00010'}, 'secondaryIdInfos': [{'id': '2005-005974-64'}, {'id': 'SPAIN'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Symbicort (budesonide/formoterol) Turbuhaler', 'type': 'DRUG'}, {'name': 'Conventional treatment', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'A Coruña', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'city': 'Alagón', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 41.76964, 'lon': -1.11906}}, {'city': 'Alicante', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'city': 'Almoradí', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 38.10879, 'lon': -0.79197}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Burgos', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 42.34106, 'lon': -3.70184}}, {'city': 'Cadiz', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 36.52672, 'lon': -6.2891}}, {'city': 'Caravaca', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 38.10558, 'lon': -1.86343}}, {'city': 'Cartagena', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 37.60197, 'lon': -0.98397}}, {'city': 'Coslada', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 40.42378, 'lon': -3.56129}}, {'city': 'Córdoba', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'city': 'Donostia / San Sebastian', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 43.31283, 'lon': -1.97499}}, {'city': 'Dos Hermanas', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 37.28287, 'lon': -5.92088}}, {'city': 'Elche', 'country': 'Spain', 'facility': 'Research Site', 'geoPoint': {'lat': 38.26218, 'lon': 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