Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-02-20 @ 1:45 PM
Study NCT ID:
NCT00652392
Status:
COMPLETED
Last Update Posted:
2011-01-24
First Post:
2008-04-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Symbicort pMDI Administered Once Daily in Adolescents and Adults During 12 Weeks - STEM
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'}, {'id': 'D019819', 'term': 'Budesonide'}], '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': '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': 750}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2004-06', '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': 'Change in evening PEF', 'timeFrame': 'Daily throughout the 12 week treatment period'}], 'secondaryOutcomes': [{'measure': 'Lung function, asthma symptoms, use of rescue medication and parent/caregiver/physician reported outcomes', 'timeFrame': 'Daily throughout the 12 week treatment period'}, {'measure': 'Health-related quality of life', 'timeFrame': '4 assessments within 12 week treatment period'}, {'measure': 'Routine safety assessments', 'timeFrame': '4 assessments within 12 week treatment period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['asthma', 'adolescents', 'adults', 'Symbicort', 'budesonide/formoterol', 'budesonide'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '20167145', 'type': 'DERIVED', 'citation': "Berger WE, Bleecker ER, O'Dowd L, Miller CJ, Mezzanotte W. Efficacy and safety of budesonide/formoterol pressurized metered-dose inhaler: randomized controlled trial comparing once- and twice-daily dosing in patients with asthma. Allergy Asthma Proc. 2010 Jan-Feb;31(1):49-59. doi: 10.2500/aap.2010.31.3309."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare a dose of Symbicort taken once daily with other dosage regimens of Symbicort , budesonide and placebo for the treatment of asthma in adolescents and adults'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of asthma and baseline lung function tests 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* Severe asthma\n* Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in protocol or requires treatment with beta-blockers'}, 'identificationModule': {'nctId': 'NCT00652392', 'briefTitle': 'Efficacy of Symbicort pMDI Administered Once Daily in Adolescents and Adults During 12 Weeks - STEM', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A 12 Week, Randomized, Double-Blind, Double-Dummy, Placebo and Active-controlled Study of Symbicort pMDI Administered Once Daily in Adults and Adolescents With Asthma - STEM', 'orgStudyIdInfo': {'id': 'SD-039-0726'}, 'secondaryIdInfos': [{'id': 'D5896C00726'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: budesonide/formoterol']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: budesonide and placebo']}], 'interventions': [{'name': 'budesonide/formoterol', 'type': 'DRUG', 'otherNames': ['Symbicort'], 'armGroupLabels': ['1']}, {'name': 'budesonide and placebo', 'type': 'DRUG', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Catherine Bonuccelli', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}