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

Completed

• Conditions: Asthma

• Registration Number: NCT00937066
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-09
• Study First Submitted QC: 2009-07-09
• Study First Posted: 2009-07-10
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-21
• Last Update Posted: 2011-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Moderate to severe asthma.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Estimate incremental cost-effectiveness ratio using Symbicort as Maintenance and Reliever Therapy in the pharmacologic management of patients when compared with competitive alternatives	12 months
Incremental cost-effectiveness ratio from using Symbicort as symbicort as Maintenance and Reliever Therapy when compared with its competitive alternatives	12 Months

Trial Locations

Locations (1)

Research Site; 🇨🇴 Bogota, Colombia