Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-28 @ 1:02 AM
Study NCT ID:
NCT00937066
Status:
COMPLETED
Last Update Posted:
2011-01-24
First Post:
2009-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cost-effectiveness Study of Symbicort as Maintenance and Reliever Therapy (SMART)
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
Management of Patients With Moderate to Severe Asthma Uncontrolled When Treated With Low Dose Inhaled Corticosteroids: Cost-effectiveness of Three Therapeutics Alternatives
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: