Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2026-02-24 @ 7:19 AM
Study NCT ID:
NCT00319306
Status:
COMPLETED
Last Update Posted:
2009-03-17
First Post:
2006-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real Life Effectiveness in Asthma of Symbicort Single Inhaler Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}], 'ancestors': [{'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 550}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-16', 'studyFirstSubmitDate': '2006-04-27', 'studyFirstSubmitQcDate': '2006-04-27', 'lastUpdatePostDateStruct': {'date': '2009-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "In a real life setting, to compare Symbicort® Single Inhaler Therapy with a patient's previous therapy (including low dose ICS), by assessment of the changes in the Asthma Control Questionnaire score in uncontrolled asthmatic patients."}], 'secondaryOutcomes': [{'measure': 'Change in forced expiratory volume in one second (FEV1)'}, {'measure': 'Change in peak expiratory flow (PEF)'}, {'measure': 'Patient Reported Outcomes: AQLQ(S), SATQ, RCP-3 scores'}]}, 'conditionsModule': {'keywords': ['Respiratory Tract Diseases', 'Bronchial Diseases', 'Anti-asthmatic agents', 'Anti-asthmatic drugs', 'Bronchodilators'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether patients with asthma are better able to manage and control their symptoms by using one inhaler daily that both prevents as well as treats the symptoms of an asthma exacerbation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged over 18\n* Confirmed diagnosis of mild to moderate asthma by doctor\n* Currently receiving inhaled corticoid-steroid medicine for treatment of asthma and requiring a review of current asthma treatment\n\nExclusion Criteria:\n\n* Women who are pregnant, breast-feeding, or planning pregnancy\n* Patients with a history of chronic obstructive pulmonary disease\n* Patients using any beta blocker therapy\n* Patients receiving steroid tablets or steroid injections'}, 'identificationModule': {'nctId': 'NCT00319306', 'acronym': 'RELEASE', 'briefTitle': 'Real Life Effectiveness in Asthma of Symbicort Single Inhaler Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Real Life Effectiveness in Asthma of Symbicort Single Inhaler Therapy', 'orgStudyIdInfo': {'id': 'D5890L00012'}, 'secondaryIdInfos': [{'id': 'RELEASE'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Budesonide/formoterol', 'type': 'DRUG'}, {'name': 'Symbicort® Turbohaler®', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fowey', 'state': 'Cornwall', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 50.33634, 'lon': -4.6386}}, {'city': 'Hove', 'state': 'East Sussex', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 50.83088, 'lon': -0.1672}}, {'city': 'Ilford', 'state': 'Essex', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.55765, 'lon': 0.07278}}, {'city': 'Glenrothes', 'state': 'Fife', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 56.19514, 'lon': -3.17316}}, {'city': 'Dartford', 'state': 'Kent', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.44657, 'lon': 0.21423}}, {'city': 'Airdrie', 'state': 'Lanarkshire', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 55.86602, 'lon': -3.98025}}, {'city': 'Hamilton', 'state': 'Lanarkshire', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 55.76667, 'lon': -4.03333}}, {'city': 'Doncaster', 'state': 'North Yorkshire', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.52285, 'lon': -1.13116}}, {'city': 'Cookstown', 'state': 'Northern Ireland', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 54.64305, 'lon': -6.74595}}, {'city': 'Downpatrick', 'state': 'Northern Ireland', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 54.32814, 'lon': -5.71529}}, {'city': 'Barry', 'state': 'South Glamorgan', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.39979, 'lon': -3.2838}}, {'city': 'Chase Terrace', 'state': 'Staffordshire', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 52.68805, 'lon': -1.93671}}, {'city': 'East Horsley', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.27358, 'lon': -0.43207}}, {'city': 'Crawley', 'state': 'West Sussex', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.11303, 'lon': -0.18312}}, {'city': 'Box', 'state': 'Wiltshire', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.41472, 'lon': -2.24556}}, {'city': 'Bradford-on-Avon', 'state': 'Wiltshire', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.34772, 'lon': -2.25065}}, {'city': 'Ashford', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.14648, 'lon': 0.87376}}, {'city': 'Atherstone', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 52.57536, 'lon': -1.54693}}, {'city': 'Ayrshire', 'country': 'United Kingdom', 'facility': 'Research Site'}, {'city': 'Bath', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.3751, 'lon': -2.36172}}, {'city': 'Blackpool', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.81667, 'lon': -3.05}}, {'city': 'Bolton', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.58333, 'lon': -2.43333}}, {'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'city': 'Carrickfergus', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 54.7158, 'lon': -5.8058}}, {'city': 'Cheshire', 'country': 'United Kingdom', 'facility': 'Research Site'}, {'city': 'Chesterfield', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.25, 'lon': -1.41667}}, {'city': 'Coventry', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'city': 'Dundee', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}, {'city': 'Ellesmere Port', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.27875, 'lon': -2.90134}}, {'city': 'Fife', 'country': 'United Kingdom', 'facility': 'Research Site'}, {'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'Harrow', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.57835, 'lon': -0.33208}}, {'city': 'Larne', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 54.85, 'lon': -5.81667}}, {'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'city': 'Middlesbrough', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 54.57623, 'lon': -1.23483}}, {'city': 'Newcastle', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 54.21804, 'lon': -5.88979}}, {'city': 'Newtownabbey', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 54.65983, 'lon': -5.90858}}, {'city': 'Peterhead', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 57.50517, 'lon': -1.78435}}, {'city': 'Pontypridd', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.6021, 'lon': -3.34211}}, {'city': 'Reading', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}, {'city': 'Rugby', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 52.37092, 'lon': -1.26417}}, {'city': 'Rutherglen', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 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'facility': 'Research Site', 'geoPoint': {'lat': 51.45647, 'lon': -1.0437}}, {'city': 'Tonbridge', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.19532, 'lon': 0.27363}}, {'city': 'Trowbridge', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.31889, 'lon': -2.20861}}, {'city': 'Vale of Glamorgan', 'country': 'United Kingdom', 'facility': 'Research Site'}, {'city': 'Warminster', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.20434, 'lon': -2.17873}}, {'city': 'Watford', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.65531, 'lon': -0.39602}}, {'city': 'Wells-next-the-Sea', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 52.95164, 'lon': 0.8511}}, {'city': 'Westbury', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.26, 'lon': -2.1875}}, {'city': 'Woking', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.31903, 'lon': -0.55893}}, {'city': 'Yaxley', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 52.51768, 'lon': -0.25852}}], 'overallOfficials': [{'name': 'Iain Small, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'General Practitioner'}, {'name': 'AstraZeneca UK Medical Director, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}