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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00937066
First received: July 9, 2009
Last updated: January 21, 2011
Last verified: January 2011
  Purpose

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.

Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Management of Patients With Moderate to Severe Asthma Uncontrolled When Treated With Low Dose Inhaled Corticosteroids: Cost-effectiveness of Three Therapeutics Alternatives

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Incremental cost-effectiveness ratio from using Symbicort as symbicort as Maintenance and Reliever Therapy when compared with its competitive alternatives [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Enrollment: 1000
Groups/Cohorts
1
Adult patients 18-65 years with moderate to severe uncontrolled asthma

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care

Criteria

Inclusion Criteria:

  • Moderate to severe asthma.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937066

Locations
Colombia
Research Site
Bogota, Colombia
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Rodolfo Dennis, M.D. Pontificia Universidad Javeriana
Principal Investigator: MARÍA XIMENA ROJAS, M.D. Pontificia Universidad Javeriana
  More Information

No publications provided

Responsible Party: MC MD, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00937066     History of Changes
Other Study ID Numbers: NIS-RC0-SYM-2007/1
Study First Received: July 9, 2009
Last Updated: January 21, 2011
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by AstraZeneca:
Cost-effectiveness analysis
Symbicort

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Symbicort
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014