Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
Study NCT ID:
NCT01232335
Status:
COMPLETED
Last Update Posted:
2013-05-29
First Post:
2010-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Symbicort Turbuhaler 30/60 Specific Clinical Experience Investigation
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-28', 'studyFirstSubmitDate': '2010-10-31', 'studyFirstSubmitQcDate': '2010-10-31', 'lastUpdatePostDateStruct': {'date': '2013-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse Events', 'timeFrame': 'Range of one year'}], 'secondaryOutcomes': [{'measure': 'The level of asthma control under long-term use', 'timeFrame': 'At the end of 24 weeks'}, {'measure': 'The level of asthma control under long-term use', 'timeFrame': 'At the end of one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bronchial asthma', 'Symbicort', 'long term use,'], 'conditions': ['Bronchial Asthma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to confirm the safety profile for long term treatment and maximize doses and the control status on bronchial asthma in daily clinical usage'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated with Symbicort for the first time due to bronchial asthma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients treated with Symbicort for the first time possibly at the higher dose due to bronchial asthma\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01232335', 'acronym': 'ENSURE', 'briefTitle': 'Symbicort Turbuhaler 30/60 Specific Clinical Experience Investigation', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Symbicort Turbuhaler 30/60 Specific Clinical Experience Investigation for Long-term Use', 'orgStudyIdInfo': {'id': 'D589IC00001'}}, 'contactsLocationsModule': {'locations': [{'city': 'Aichi', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Akita', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 39.71667, 'lon': 140.11667}}, {'city': 'Aomori', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 40.81667, 'lon': 140.73333}}, {'city': 'Chiba', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Ehime', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site'}, {'city': 'Fukui', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.84214, 'lon': 135.54836}}, {'city': 'Fukuoka', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukushima', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 37.75, 'lon': 140.46667}}, {'city': 'Gifu', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'city': 'Gunma', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site'}, {'city': 'Hiroshima', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Hokkaido', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site'}, {'city': 'Hyōgo', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'city': 'Ibaraki', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.81641, 'lon': 135.56828}}, {'city': 'Ishikawa', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 26.42333, 'lon': 127.82139}}, {'city': 'Kagawa', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.06667, 'lon': 131.03333}}, {'city': 'Kagoshima', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'city': 'Kanagawa', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'city': 'Kochi', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.55, 'lon': 133.53333}}, {'city': 'Kumamoto', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'city': 'Kyoto', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Mie', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 32.96667, 'lon': 131.58333}}, {'city': 'Miyagi', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 26.62566, 'lon': 128.18236}}, {'city': 'Miyazaki', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 31.91667, 'lon': 131.41667}}, {'city': 'Nagano', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.65, 'lon': 138.18333}}, {'city': 'Nagasaki', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'city': 'Nara', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.68505, 'lon': 135.80485}}, {'city': 'Niigata', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'city': 'Numakunai', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 39.96667, 'lon': 141.21667}}, {'city': 'Okayama', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Okinawa', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 26.33583, 'lon': 127.80139}}, {'city': 'Osaka', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Ōita', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.23333, 'lon': 131.6}}, {'city': 'Saga', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.23333, 'lon': 130.3}}, {'city': 'Saitama', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'city': 'Shiga', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.02247, 'lon': 138.13005}}, {'city': 'Shimane', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.78334, 'lon': 139.79727}}, {'city': 'Shizuoka', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Tochigi', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.38333, 'lon': 139.73333}}, {'city': 'Tokushima', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.06667, 'lon': 134.56667}}, {'city': 'Tokyo', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tottori', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.24877, 'lon': 134.67796}}, {'city': 'Toyama', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.7, 'lon': 137.21667}}, {'city': 'Wakayama', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.23333, 'lon': 135.16667}}, {'city': 'Yamagata', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 38.23333, 'lon': 140.36667}}, {'city': 'Yamaguchi', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.18333, 'lon': 131.46667}}, {'city': 'Yamanashi', 'state': 'Japan', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.67152, 'lon': 138.69827}}], 'overallOfficials': [{'name': 'Yoshida Shigeru', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}