AsthmaNCT00937066
Cost-effectiveness Study of Symbicort as Maintenance and Reliever Therapy (SMART)
An observational study of Asthma, run by AstraZeneca at 1 site in Colombia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- How many people
- 1,000 participants
- Where
- 1 siteColombia
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care
Who may be able to join
- Moderate to severe asthma.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Patients With Moderate to Severe Asthma Uncontrolled When Treated With Low Dose Inhaled Corticosteroids: Cost-effectiveness of Three Therapeutics Alternatives
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.
- Conditions
- Asthma
- Keywords
- Cost-effectiveness analysis, Symbicort
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Adult patients 18-65 years with moderate to severe uncontrolled asthma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate incremental cost-effectiveness ratio using Symbicort as Maintenance and Reliever Therapy in the pharmacologic management of patients when compared with competitive alternatives
Measured: 12 months
Incremental cost-effectiveness ratio from using Symbicort as symbicort as Maintenance and Reliever Therapy when compared with its competitive alternatives
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Rodolfo Dennis, M.D., Study director, Pontificia Universidad JaverianaMARÍA XIMENA ROJAS, M.D., Principal investigator, Pontificia Universidad Javeriana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00937066
- Sponsor's protocol ID
- NIS-RC0-SYM-2007/1
- Status last verified
- Jan 2011
- First submitted
- 9 Jul 2009
- Last updated
- 24 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Patients With Moderate to Severe Asthma Uncontrolled When Treated With Low Dose Inhaled Corticosteroids: Cost-effectiveness of Three Therapeutics Alternatives
- ClinicalTrials.gov ID
- NCT00937066
- Acronym / sponsor ID
- NIS-RC0-SYM-2007/1
- Conditions
- Asthma
- Keywords
- Cost-effectiveness analysis, Symbicort
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- First posted
- 10 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Adult patients 18-65 years with moderate to severe uncontrolled asthma |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care
Key inclusion criteria (1 listed)
- Moderate to severe asthma.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Incremental cost-effectiveness ratio from using Symbicort as symbicort as Maintenance and Reliever Therapy when compared with its competitive alternatives
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodolfo Dennis, M.D. study director
Pontificia Universidad Javeriana
MARÍA XIMENA ROJAS, M.D. principal investigator
Pontificia Universidad Javeriana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by AstraZeneca at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2011.