Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-31 @ 11:47 PM
Study NCT ID:
NCT00785733
Status:
COMPLETED
Last Update Posted:
2010-12-02
First Post:
2008-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NIS-observe Treatment Efficacy in Maintaining Symptoms Control in Moderate/Severe Asthma With Symbicort SMART
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1182}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-30', 'studyFirstSubmitDate': '2008-11-04', 'studyFirstSubmitQcDate': '2008-11-04', 'lastUpdatePostDateStruct': {'date': '2010-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Asthma Control Questionnaire ACQ', 'timeFrame': '5 visits (V1-week 0, V2-week 4, V3-week 8, V4-week 16, V5-week 24)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['asthma'], 'conditions': ['Moderate/Severe Asthma']}, 'descriptionModule': {'briefSummary': 'The primary objective of this non-interventional study is to evaluate efficacy of Symbicort® SMART treatment in adult patients with moderate to severe asthma using ACQ scores during 6 months period'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The programme will include patients with moderate and severe asthma stabilized on Symbicort SMART from community sample', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients eligible for entry into study are the patients diagnosed with moderate to severe asthma, that the doctors have already decided to treat with Symbicort SMART within the last month, before inclusion in this program\n* All eligible patients will be included in the protocol provided they will receive detailed information in advance and will sign consent to grant access to their own data collected during this programme.\n\nExclusion Criteria:\n\n* All the patients who have a known hypersensitivity to Symbicort or any of its excipients will not be included in this study.\n* As per valid Romanian SmPC, concomitant medication, that could result in drug interactions and could jeopardise patient safety will be carefully considered before having the patient enrolled.'}, 'identificationModule': {'nctId': 'NCT00785733', 'briefTitle': 'NIS-observe Treatment Efficacy in Maintaining Symptoms Control in Moderate/Severe Asthma With Symbicort SMART', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'SMART Way of Treating Asthma. Non-interventional Study to Evaluate Clinical Efficacy of Symbicort® Maintenance And Reliever Therapy (Symbicort® SMART) in the Treatment of Patients With Moderate and Severe Asthma', 'orgStudyIdInfo': {'id': 'NIS-RRO-SYM-2008/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Moderate and severe asthma patients stabilized on Symbicort SMART'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alba Iulia', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 46.06667, 'lon': 23.58333}}, {'city': 'Alexandria', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 43.98333, 'lon': 25.33333}}, {'city': 'Arad', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 46.18333, 'lon': 21.31667}}, {'city': 'Bacau', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 46.56718, 'lon': 26.91384}}, {'city': 'Baia Mare', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 47.65729, 'lon': 23.56808}}, {'city': 'Botoșani', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 47.75, 'lon': 26.66667}}, {'city': 'Brasov', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 45.64861, 'lon': 25.60613}}, {'city': 'Brăila', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 45.27152, 'lon': 27.97429}}, {'city': 'Breaza', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 45.18333, 'lon': 25.66667}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Buftea', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 44.56139, 'lon': 25.94889}}, {'city': 'Campulung Muscel', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 45.26667, 'lon': 25.05}}, {'city': 'Câmpina', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 45.12619, 'lon': 25.73496}}, {'city': 'Călăraşi', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 44.2051, 'lon': 27.31356}}, {'city': 'Cluj-Napoca', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'city': 'Constanța', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 44.18073, 'lon': 28.63432}}, {'city': 'Craiova', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'city': 'Deva', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 45.88333, 'lon': 22.9}}, {'city': 'Drobeta-Turnu Severin', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 44.62693, 'lon': 22.65288}}, {'city': 'Giurgiu', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 43.88664, 'lon': 25.9627}}, {'city': 'Hunedoara', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 45.75, 'lon': 22.9}}, {'city': 'Iași', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'city': 'Leordeni', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 44.78333, 'lon': 25.11667}}, {'city': 'Miercurea-Ciuc', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 46.35, 'lon': 25.8}}, {'city': 'Mizil', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 45.01667, 'lon': 26.45}}, {'city': 'Oradea', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 47.0458, 'lon': 21.91833}}, {'city': 'Palazu Mare', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 44.22902, 'lon': 28.60114}}, {'city': 'Piatra Neamţ', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 46.91667, 'lon': 26.33333}}, {'city': 'Piteşti', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 44.85, 'lon': 24.86667}}, {'city': 'Ploieşti', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 44.95, 'lon': 26.01667}}, {'city': 'Reşiţa', 'country': 'Romania', 'facility': 'Research Site', 'geoPoint': {'lat': 45.30083, 'lon': 21.88917}}, {'city': 'Rm. 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