Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-04-11 @ 3:32 PM
Study NCT ID:
NCT00646594
Status:
COMPLETED
Last Update Posted:
2009-03-27
First Post:
2008-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atlantis Symbicort
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': 'D000068759', 'term': 'Formoterol Fumarate'}, {'id': 'D000069502', 'term': 'Budesonide, Formoterol Fumarate Drug Combination'}, {'id': 'D000068298', 'term': 'Fluticasone'}, {'id': 'D000068299', 'term': 'Salmeterol Xinafoate'}, {'id': 'D000068297', 'term': 'Fluticasone-Salmeterol Drug Combination'}], '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'}, {'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D000420', 'term': 'Albuterol'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-26', 'studyFirstSubmitDate': '2008-03-26', 'studyFirstSubmitQcDate': '2008-03-27', 'lastUpdatePostDateStruct': {'date': '2009-03-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Asthma control assessed by asthma exacerbations', 'timeFrame': 'Continuosly throughout the treatment period'}], 'secondaryOutcomes': [{'measure': 'Efficacy of Symbicort compared with Advair as assessed by use of rescue medication, asthma symptoms, lung function tests, quality of life reports, patient reported asthma control and patient satisfaction of Symbicort.', 'timeFrame': 'Daily and at 1, 3 and 6 months after start of treatmen'}, {'measure': 'Use of medical resources and medication for the treatment of asthma.', 'timeFrame': 'Throughout the treatment period'}, {'measure': 'Investigate safety profile of Symbicort compared to Advair', 'timeFrame': '1, 3 and 6 months after start of treatment and 1 week after end of tretment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma', 'inhaled cortocisteroids', 'Symbicort', 'budesonide/formoterol', 'Advair', 'fluticasone/salmeterol'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '36472162', 'type': 'DERIVED', 'citation': 'Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.'}, {'pmid': '20170333', 'type': 'DERIVED', 'citation': "O'Connor RD, Patrick DL, Parasuraman B, Martin P, Goldman M. Comparison of patient-reported outcomes during treatment with adjustable- and fixed-dose budesonide/formoterol pressurized metered-dose inhaler versus fixed-dose fluticasone propionate/salmeterol dry powder inhaler in patients with asthma. J Asthma. 2010 Mar;47(2):217-23. doi: 10.3109/02770900903497154."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Symbicort compared with Advair, will be more effective in controlling asthma in adults and adolescents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of asthma\n* Baseline lung function tests as determined by protocol\n* Required and received treatment with inhaled corticosteroids within timeframe and doses specified in protocol\n\nExclusion Criteria:\n\n* Has required treatment with any non-inhaled corticosteroid within previous 30 days, sensitivity to drugs specified in the protocol, or requires treatment with a beta-blockers\n* Had cancer within previous 5 years or currently has any other significant disease or disorder as judged by the investigator'}, 'identificationModule': {'nctId': 'NCT00646594', 'briefTitle': 'Atlantis Symbicort', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Two Stage Randomized, Open-Label, Parallel Group, Phase III, Multicenter, 7 Month Study to Assess the Efficacy & Safety of SYMBICORT pMDI Adminstered Either as Fixed or as an Adjustable Regimen Versus a Fixed Regimen of Advair in Subjects 12 Yrs of Age and Older With Asthma.', 'orgStudyIdInfo': {'id': 'D5896C00005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'budesonide/formoterol', 'interventionNames': ['Drug: budesonide/formoterol (Symbicort)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'fluticasone/salmeterol', 'interventionNames': ['Drug: fluticasone/salmeterol (Advair)']}], 'interventions': [{'name': 'budesonide/formoterol (Symbicort)', 'type': 'DRUG', 'otherNames': ['Symbicort'], 'armGroupLabels': ['1']}, {'name': 'fluticasone/salmeterol (Advair)', 'type': 'DRUG', 'otherNames': ['Advair'], 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mitchell Golmand, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}, {'name': 'Catherine Bonuccelli', 'role': 'STUDY_CHAIR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}