Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-25 @ 5:31 PM
Study NCT ID:
NCT01203904
Status:
COMPLETED
Last Update Posted:
2016-06-07
First Post:
2010-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pulmicort Turbuhaler 100/200 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': 301}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-06', 'studyFirstSubmitDate': '2010-09-06', 'studyFirstSubmitQcDate': '2010-09-15', 'lastUpdatePostDateStruct': {'date': '2016-06-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse event incidence. We will investigate, intensively, development of Adverse Drug Reactions, especially infections. Detection of Adverse Drug Reactions unexpected from the Precautions for use.', 'timeFrame': 'Two years'}, {'measure': 'Effects on growth rate and the adrenal cortical function, development of infections', 'timeFrame': 'Two years'}], 'secondaryOutcomes': [{'measure': 'Variation of the asthma control status (total of JPAC：Japanese Pediatric Asthma Control Program score) from the baseline score.', 'timeFrame': 'Two years'}, {'measure': 'Variation of the parental questionnaire (score by factor) from the baseline score.', 'timeFrame': 'Two years'}]}, 'conditionsModule': {'keywords': ['bronchial asthma, Pulmicort, long term use, pediatrics'], 'conditions': ['Bronchial Asthma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=499&filename=Pulmicort-sCEI_synopsis_20160606.pdf', 'label': 'CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to confirm the safety profile for long term treatment in children aged 5 years and \\<15 years on bronchial asthma in daily clinical usage/Effect on growth rate. Effect on adrenal function. Development of infection diseases by diseases type.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated with Pulmicort Turbuhaler for the firtst time due to bronchial asthma and children of \\>= 5 years and \\< 15 years old age at the start of study treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients treated with Pulmicort Turbuhaler for the first time due to bronchial asthma and children of \\>= 5 years and \\< 15 years old age at the start of study treatment\n\nExclusion Criteria: -None'}, 'identificationModule': {'nctId': 'NCT01203904', 'acronym': 'PEACE-Peds', 'briefTitle': 'Pulmicort Turbuhaler 100/200 Specific Clinical Experience Investigation', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Pulmicort Turbuhaler 100/200 Specific Clinical Experience Investigation for Long Term Use in Pediatrics', 'orgStudyIdInfo': {'id': 'D525AL00001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pulmicort'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aichi', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Chiba', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Ehime', 'country': 'Japan', 'facility': 'Research Site'}, {'city': 'Fukui', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.84214, 'lon': 135.54836}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukushima', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 37.75, 'lon': 140.46667}}, {'city': 'Gifu', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'city': 'Gunma', 'country': 'Japan', 'facility': 'Research Site'}, {'city': 'Hiroshima', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Hokkaido', 'country': 'Japan', 'facility': 'Research Site'}, {'city': 'Hyōgo', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'city': 'Ibaraki', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.81641, 'lon': 135.56828}}, {'city': 'Kagawa', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.06667, 'lon': 131.03333}}, {'city': 'Kagoshima', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'city': 'Kanagawa', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'city': 'Kochi', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.55, 'lon': 133.53333}}, {'city': 'Kyoto', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Mie', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 32.96667, 'lon': 131.58333}}, {'city': 'Miyagi', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 26.62566, 'lon': 128.18236}}, {'city': 'Nagano', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.65, 'lon': 138.18333}}, {'city': 'Niigata', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'city': 'Numakunai', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 39.96667, 'lon': 141.21667}}, {'city': 'Okayama', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Ōita', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.23333, 'lon': 131.6}}, {'city': 'Saga', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.23333, 'lon': 130.3}}, {'city': 'Saitama', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'city': 'Shiga', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.02247, 'lon': 138.13005}}, {'city': 'Shimane', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.78334, 'lon': 139.79727}}, {'city': 'Shizuoka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Tochigi', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.38333, 'lon': 139.73333}}, {'city': 'Tokushima', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.06667, 'lon': 134.56667}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tottori', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.24877, 'lon': 134.67796}}, {'city': 'Toyama', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.7, 'lon': 137.21667}}, {'city': 'Yamagata', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 38.23333, 'lon': 140.36667}}, {'city': 'Yamaguchi', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.18333, 'lon': 131.46667}}], 'overallOfficials': [{'name': 'Shigeru Yoshida', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZenecaKK'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}