Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-04-15 @ 12:50 PM
Study NCT ID:
NCT00651768
Status:
COMPLETED
Last Update Posted:
2011-01-24
First Post:
2008-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Titratable Dosing in Moderate to Severe Asthmatics
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': 'D000069502', 'term': 'Budesonide, Formoterol Fumarate Drug Combination'}], 'ancestors': [{'id': 'D000068759', 'term': 'Formoterol Fumarate'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D019819', 'term': 'Budesonide'}, {'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': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 570}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-21', 'studyFirstSubmitDate': '2008-04-01', 'studyFirstSubmitQcDate': '2008-04-02', 'lastUpdatePostDateStruct': {'date': '2011-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Asthma exacerbations, ECG and Holter monitors, lung function, adverse events, requirement of other asthma therapies and other routine safety assessments.', 'timeFrame': '7 assessments within 12 month treatment period'}], 'secondaryOutcomes': [{'measure': 'To measure changes in lung function tests, patient reported outcomes and usage of medical resource', 'timeFrame': '7 assessments within 12 month treatment period'}, {'measure': 'Blood levels of budesonide and formoterol', 'timeFrame': '10 blood samples taken at 1 visit in a sub-set of patients'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['asthma', 'adults', 'adolescents', 'safety', 'Symbicort', 'budesonide/formoterol', 'budesonide'], '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the long term safety of Symbicort with budesonide alone, in adolescents and adults with asthma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of asthma and baseline lung function tests, symptoms and medication use as determined by the protocol\n* Required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol\n\nExclusion Criteria:\n\n* Has required treatment with non-inhaled corticosteroids within previous 30 days, has sensitivity to drugs specified in the protocol or requires treatment with a beta-blocker.\n* Has had cancer within previous 5 years or has a condition that may put the patient at risk in this study.'}, 'identificationModule': {'nctId': 'NCT00651768', 'briefTitle': 'Titratable Dosing in Moderate to Severe Asthmatics', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A 52 wk Randomized, Doubleblind, Single Dummy, Parallel Group Multicenter Phase 3 Study Comparing the Long Term Safety of Symbicort pMDI 4x160/4.5mcg Bid to SymbicortpMDI 2x160/4.5mcg Bid & Budesonide HFA pMDI 4x160mcg Bid in Adult and Adolescent Subjects With Asthma', 'orgStudyIdInfo': {'id': 'SD-039-0728'}, 'secondaryIdInfos': [{'id': 'D5896C00728'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: budesonide/formoterol']}, {'type': 'SHAM_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Symbicort pMDI + budesonide HFA pMDI']}], 'interventions': [{'name': 'budesonide/formoterol', 'type': 'DRUG', 'otherNames': ['Symbicort'], 'armGroupLabels': ['1']}, {'name': 'Symbicort pMDI + budesonide HFA pMDI', 'type': 'DRUG', 'description': 'Symbicort 2 X 160/4.5mcg \\& budesonide HFA pMDI 4 X 160mcg', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Catherine Bonuccelli', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}