Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-28 @ 1:02 AM
Study NCT ID:
NCT00937066
Status:
COMPLETED
Last Update Posted:
2011-01-24
First Post:
2009-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cost-effectiveness Study of Symbicort as Maintenance and Reliever Therapy (SMART)
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'lastUpdateSubmitDate': '2011-01-21', 'studyFirstSubmitDate': '2009-07-09', 'studyFirstSubmitQcDate': '2009-07-09', 'lastUpdatePostDateStruct': {'date': '2011-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimate incremental cost-effectiveness ratio using Symbicort as Maintenance and Reliever Therapy in the pharmacologic management of patients when compared with competitive alternatives', 'timeFrame': '12 months'}, {'measure': 'Incremental cost-effectiveness ratio from using Symbicort as symbicort as Maintenance and Reliever Therapy when compared with its competitive alternatives', 'timeFrame': '12 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cost-effectiveness analysis', 'Symbicort'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'This study is an economic evaluation of Symbicort (Budesonide/formoterol) as maintenance and reliever therapy (SMART) versus its competitive alternatives.\n\nThe aims of this study are:\n\n* To estimate the relative effectiveness of each one of the alternatives in the management of patients with moderate to severe asthma through a systematic review for the following outcomes:\n\n * Cumulative incidence of asthma severe exacerbations symptoms\n * Safety of each alternative (frequency of adverse events and complications due to the medications)\n* To estimate the direct medical costs of treating with each pharmacologic alternative: Symbicort as SMART versus increased use of inhaled corticosteroids or Adding long-acting inhaled beta 2 agonist plus inhaled corticosteroids.\n* To create a decision analysis model (decision tree) that allows comparisons between the alternatives on expected values and costs.\n* To calculate the average and incremental cost-effectiveness ratios.\n* To carry out a sensitivity analysis to test de robustness of the cost-effectiveness results allowing for reasonable changes in expected values and costs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate to severe asthma.'}, 'identificationModule': {'nctId': 'NCT00937066', 'briefTitle': 'Cost-effectiveness Study of Symbicort as Maintenance and Reliever Therapy (SMART)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Management of Patients With Moderate to Severe Asthma Uncontrolled When Treated With Low Dose Inhaled Corticosteroids: Cost-effectiveness of Three Therapeutics Alternatives', 'orgStudyIdInfo': {'id': 'NIS-RC0-SYM-2007/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Adult patients 18-65 years with moderate to severe uncontrolled asthma'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bogotá', 'country': 'Colombia', 'facility': 'Research Site', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}], 'overallOfficials': [{'name': 'Rodolfo Dennis, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pontificia Universidad Javeriana'}, {'name': 'MARÍA XIMENA ROJAS, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pontificia Universidad Javeriana'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'MC MD', 'oldOrganization': 'AstraZeneca Pharmaceuticals'}}}}