Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-25 @ 2:26 PM
Study NCT ID:
NCT00259766
Status:
COMPLETED
Last Update Posted:
2011-01-24
First Post:
2005-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SHARE - Symbicort and Health Economics in a Real Life Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D019819', 'term': 'Budesonide'}, {'id': 'D000069502', 'term': 'Budesonide, Formoterol Fumarate Drug Combination'}, {'id': 'D000068759', 'term': 'Formoterol Fumarate'}, {'id': 'D013726', 'term': 'Terbutaline'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 1970}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-21', 'studyFirstSubmitDate': '2005-11-25', 'studyFirstSubmitQcDate': '2005-11-28', 'lastUpdatePostDateStruct': {'date': '2011-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Asthma-related health-care utilization as measured by total amount of asthma medication purchased and number of contacts with health-care facilities'}], 'secondaryOutcomes': [{'measure': "Number of days patients or assistant persons are absent from work due to patient's asthma"}, {'measure': 'Number of exacerbations and treatment failures'}]}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare health-related costs and asthma control in ordinary clinical practice during 12 months for Symbicort® given as a low maintenance dose plus as needed compared to a free combination of Pulmicortâ and Oxis® plus Bricanyl® as needed, and Symbicort fixed dosing plus Bricanyl as needed in asthmatic patients not adequately controlled on inhaled glucocorticosteroids alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent,\n* asthma,\n* previously treated with glucocorticosteroids and B2-agonist\n\nExclusion Criteria:\n\n* History of smoking, pregnancy, any significant disease or disorder which may put the patient at risk because of study participation'}, 'identificationModule': {'nctId': 'NCT00259766', 'briefTitle': 'SHARE - Symbicort and Health Economics in a Real Life Evaluation', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Symbicort and Health Economics in a Real Life Evaluation - SHARE - A Randomised, Open-Label, Parallel-Group, Multicentre Study to Assess the Asthma-Related Health-Care Costs, in Ordinary Clinical Practice During 12 Months', 'orgStudyIdInfo': {'id': 'D5890L00001'}, 'secondaryIdInfos': [{'id': 'SHARE'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Budesonide', 'type': 'DRUG', 'otherNames': ['Symbicort']}, {'name': 'Formoterol', 'type': 'DRUG'}, {'name': 'Terbutaline', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alingsås', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 57.93033, 'lon': 12.53345}}, {'city': 'Angered', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 57.78628, 'lon': 12.09852}}, {'city': 'Arlöv', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 55.63248, 'lon': 13.07141}}, {'city': 'Arvidsjaur', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 65.59033, 'lon': 19.16682}}, {'city': 'Arvika', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.65528, 'lon': 12.58518}}, {'city': 'Ängelholm', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 56.2428, 'lon': 12.86219}}, {'city': 'Åkersberga', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.47944, 'lon': 18.29967}}, {'city': 'Ånge', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 62.52495, 'lon': 15.65904}}, {'city': 'Årsta', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.2978, 'lon': 18.0514}}, {'city': 'Åstorp', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 56.13566, 'lon': 12.9443}}, {'city': 'Åtvidaberg', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 58.20152, 'lon': 15.9977}}, {'city': 'Bandhagen', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.27068, 'lon': 18.04839}}, {'city': 'Boden', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 65.82518, 'lon': 21.68864}}, {'city': 'Borensberg', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': 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