Cost-effectiveness Study of Symbicort as Maintenance and Reliever Therapy (SMART)
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.
|Study Design:||Observational Model: Cohort|
|Official Title:||Management of Patients With Moderate to Severe Asthma Uncontrolled When Treated With Low Dose Inhaled Corticosteroids: Cost-effectiveness of Three Therapeutics Alternatives|
- 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 ] [ Designated as safety issue: No ]
- Incremental cost-effectiveness ratio from using Symbicort as symbicort as Maintenance and Reliever Therapy when compared with its competitive alternatives [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
Adult patients 18-65 years with moderate to severe uncontrolled asthma
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937066
|Study Director:||Rodolfo Dennis, M.D.||Pontificia Universidad Javeriana|
|Principal Investigator:||MARÍA XIMENA ROJAS, M.D.||Pontificia Universidad Javeriana|