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

NCT00937066 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2011-01-24

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

Principal Investigators

  • Rodolfo Dennis, M.D. · Pontificia Universidad Javeriana

  • MARÍA XIMENA ROJAS, M.D. · Pontificia Universidad Javeriana

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • Colombia

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00937066 on ClinicalTrials.gov