Cost-effectiveness Study of Symbicort as Maintenance and Reliever Therapy (SMART)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00937066
First received: July 9, 2009
Last updated: January 21, 2011
Last verified: January 2011
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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 June 18, 2013