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

January 21, 2011 updated by: AstraZeneca

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

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Bogota, Colombia
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care

Description

Inclusion Criteria:

  • Moderate to severe asthma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Adult patients 18-65 years with moderate to severe uncontrolled asthma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months
Incremental cost-effectiveness ratio from using Symbicort as symbicort as Maintenance and Reliever Therapy when compared with its competitive alternatives
Time Frame: 12 Months
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

July 9, 2009

First Submitted That Met QC Criteria

July 9, 2009

First Posted (Estimate)

July 10, 2009

Study Record Updates

Last Update Posted (Estimate)

January 24, 2011

Last Update Submitted That Met QC Criteria

January 21, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-RC0-SYM-2007/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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