Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-02-20 @ 10:58 PM
Study NCT ID:
NCT00646620
Status:
COMPLETED
Last Update Posted:
2009-04-06
First Post:
2008-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Symbicort Onset of Action 1
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'}, {'id': 'D000420', 'term': 'Albuterol'}], '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': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2003-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-03', 'studyFirstSubmitDate': '2008-03-26', 'studyFirstSubmitQcDate': '2008-03-27', 'lastUpdatePostDateStruct': {'date': '2009-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FEV1 3 minutes post dose', 'timeFrame': '4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)'}], 'secondaryOutcomes': [{'measure': '12 hour serial FEV1', 'timeFrame': '4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)'}, {'measure': 'Patients perception of effect', 'timeFrame': '4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['asthma', 'bronchodilatation', 'Symbicort', 'budesonide/formoterol', 'Advair Diskus', 'Ventolin'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the early onset of effect of Symbicort compared to Advair Diskus and Ventolin in adults with asthma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of asthma and baseline lung function test results as determined by protocol\n* Required and received asthma maintenance therapy within previous 4 weeks at doses determined by protocol\n\nExclusion Criteria:\n\n* Severe asthma or asthma markedly affected by seasonal factors\n* Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers'}, 'identificationModule': {'nctId': 'NCT00646620', 'briefTitle': 'Symbicort Onset of Action 1', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomized, Multicenter, Placebo and Active-Controlled, Single-Dose, 4-Period, Crossover Study to Evaluate the Bronchodilating Effect of SYMBICORT pMDI Versus Advair Diskus and Ventolin HFA.', 'orgStudyIdInfo': {'id': 'SD-039-0732'}, 'secondaryIdInfos': [{'id': 'D5896C00732'}]}, '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 Diskus)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'albuterol', 'interventionNames': ['Drug: albuterol (Ventolin)']}], 'interventions': [{'name': 'budesonide/formoterol (Symbicort)', 'type': 'DRUG', 'otherNames': ['Symbicort'], 'armGroupLabels': ['1']}, {'name': 'fluticasone/salmeterol (Advair Diskus)', 'type': 'DRUG', 'otherNames': ['Advair Diskus'], 'armGroupLabels': ['2']}, {'name': 'albuterol (Ventolin)', 'type': 'DRUG', 'otherNames': ['Ventolin'], 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Catherine Bonuccelli', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}