Cost-effectiveness Study of Symbicort as Maintenance and Reliever Therapy (SMART)
NCT ID: NCT00937066
Last Updated: 2011-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1000 participants
OBSERVATIONAL
Brief Summary
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The aims of this study are:
* 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:
* Cumulative incidence of asthma severe exacerbations symptoms
* Safety of each alternative (frequency of adverse events and complications due to the medications)
* 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.
* To create a decision analysis model (decision tree) that allows comparisons between the alternatives on expected values and costs.
* To calculate the average and incremental cost-effectiveness ratios.
* To carry out a sensitivity analysis to test de robustness of the cost-effectiveness results allowing for reasonable changes in expected values and costs.
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Detailed Description
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Conditions
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Study Design
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COHORT
Study Groups
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1
Adult patients 18-65 years with moderate to severe uncontrolled asthma
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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AstraZeneca Pharmaceuticals
Principal Investigators
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Rodolfo Dennis, M.D.
Role: STUDY_DIRECTOR
Pontificia Universidad Javeriana
MARÍA XIMENA ROJAS, M.D.
Role: PRINCIPAL_INVESTIGATOR
Pontificia Universidad Javeriana
Locations
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Research Site
Bogotá, , Colombia
Countries
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Other Identifiers
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NIS-RC0-SYM-2007/1
Identifier Type: -
Identifier Source: org_study_id
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