Cost-effectiveness Study of Symbicort as Maintenance and Reliever Therapy (SMART)
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|ClinicalTrials.gov Identifier: NCT00937066|
Recruitment Status : Completed
First Posted : July 10, 2009
Last Update Posted : January 24, 2011
This study is an economic evaluation of Symbicort (Budesonide/formoterol) as maintenance and reliever therapy (SMART) versus its competitive alternatives.
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||1000 participants|
|Official Title:||Management of Patients With Moderate to Severe Asthma Uncontrolled When Treated With Low Dose Inhaled Corticosteroids: Cost-effectiveness of Three Therapeutics Alternatives|
Adult patients 18-65 years with moderate to severe uncontrolled asthma
- Estimate incremental cost-effectiveness ratio using Symbicort as Maintenance and Reliever Therapy in the pharmacologic management of patients when compared with competitive alternatives [ Time Frame: 12 months ]
- Incremental cost-effectiveness ratio from using Symbicort as symbicort as Maintenance and Reliever Therapy when compared with its competitive alternatives [ Time Frame: 12 Months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00937066
|Study Director:||Rodolfo Dennis, M.D.||Pontificia Universidad Javeriana|
|Principal Investigator:||MARÍA XIMENA ROJAS, M.D.||Pontificia Universidad Javeriana|