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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014