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

NCT ID: NCT00937066

Last Updated: 2011-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Adult patients 18-65 years with moderate to severe uncontrolled asthma

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Moderate to severe asthma.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

AstraZeneca Pharmaceuticals

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rodolfo Dennis, M.D.

Role: STUDY_DIRECTOR

Pontificia Universidad Javeriana

MARÍA XIMENA ROJAS, M.D.

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidad Javeriana

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Bogotá, , Colombia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Colombia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NIS-RC0-SYM-2007/1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.