Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT00608218
Status:
COMPLETED
Last Update Posted:
2016-12-05
First Post:
2008-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Ciclesonide During the Cold Season in Patients Older Than 12 Years With Persistent Asthma
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': 'C120481', 'term': 'ciclesonide'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-02', 'studyFirstSubmitDate': '2008-01-23', 'studyFirstSubmitQcDate': '2008-01-23', 'lastUpdatePostDateStruct': {'date': '2016-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FEV1, symptom score assessment', 'timeFrame': 'within 3 months'}], 'secondaryOutcomes': [{'measure': 'Handling of the metered-dose inhaler, safety and tolerability', 'timeFrame': 'within 3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma', 'ciclesonide', 'inhaled steroids', 'Alvesco'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the efficacy of ciclesonide in patients with persistent asthma over 3 months, especially in the cold season. Ciclesonide will be inhaled by a metered-dose inhaler. The study will provide further data on safety and tolerability of ciclesonide.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main inclusion criteria:\n\n* History of persistent bronchial asthma\n\nMain exclusion criteria:\n\n* Hypersensitive to compounds of Alvesco\n* Other criteria as defined in the Summary of Product Characteristics (Fachinformation Chapter 4.3)'}, 'identificationModule': {'nctId': 'NCT00608218', 'acronym': 'ARTIST', 'briefTitle': 'Efficacy of Ciclesonide During the Cold Season in Patients Older Than 12 Years With Persistent Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Ciclesonide for the Therapy of Asthma During the Cold Season.', 'orgStudyIdInfo': {'id': 'Alves Artist 07/10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Artist', 'interventionNames': ['Drug: Ciclesonide']}], 'interventions': [{'name': 'Ciclesonide', 'type': 'DRUG', 'description': 'This is an observational study. 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