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NCT00937066 Clinical Trial

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

Asthma Clinical Trial

Official title:
Management of Patients With Moderate to Severe Asthma Uncontrolled When Treated With Low Dose Inhaled Corticosteroids: Cost-effectiveness of Three Therapeutics Alternatives

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00937066
Other study ID # NIS-RC0-SYM-2007/1
Secondary ID
Status Completed
Phase N/A
First received July 9, 2009
Last updated January 21, 2011

Study information
Verified date January 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1000
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Moderate to severe asthma.

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

Locations
Country Name City State
Colombia Research Site Bogota

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Colombia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Primary Incremental cost-effectiveness ratio from using Symbicort as symbicort as Maintenance and Reliever Therapy when compared with its competitive alternatives 12 Months No
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