Cost-effectiveness Study of Symbicort as Maintenance and Reliever Therapy (SMART)

AstraZeneca

Status

Completed

Conditions

Asthma

Study type

Observational

Funder types

Industry

Identifiers

NCT00937066

NIS-RC0-SYM-2007/1

Details and patient eligibility

About

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.