AsthmaSMARTNCT00523679
Symbicort SMART (Symbicort Maintenance And Reliever Therapy)
An observational study of Asthma, run by AstraZeneca at 3 sites in South Korea.
Trial summary
The purpose of this study is to investigate the extent of Symbicort use in patients prescribed Symbicort as maintenance and reliever therapy. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- How many people
- 2,000 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Jul 2007to Jul 2008
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospital Outpatient Clinics
Who may be able to join
- Asthma patients prescribed Symbicort as maintenance and reliever therapy, according to the label, before inclusion in this program.
Who cannot join
- Since this programme intends to describe Symbicort use in routine clinical practice when prescribed as Symbicort maintenance and reliever therapy, there are no programme specific exclusion criteria, other than: involvement in the planning and conduct of the programme (applies to both AstraZeneca staff or staff at the investigational site)
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Research Site
Seoul, Jongro-gu
Research Site
Seoul, Kangnam-gu
Research Site
Seoul, Songpa-gu
About this study
Official title: SMART (Symbicort Maintenance And Reliever Therapy): Reassure Program for Patients Using Symbicort Turbuhaler as Maintenance and Reliever Therapy in Korean Clinical Practice
The purpose of this study is to investigate the extent of Symbicort use in patients prescribed Symbicort as maintenance and reliever therapy.
- Conditions
- Asthma
- Keywords
- Asthma, Symbicort, SMART, inhaler, compliance, Naturalistic, Observational
- Medical subject headings
- Asthma, Patient Compliance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2007 (estimated)
- Study startJul 2007
- Study completionJul 2008
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Joon-Woo Bahn, Study director, AstraZeneca Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00523679
- Sponsor's protocol ID
- NIS-RKR-SYM-2007/1
- Acronym
- SMART
- Status last verified
- Jul 2009
- First submitted
- 29 Aug 2007
- Last updated
- 13 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMART (Symbicort Maintenance And Reliever Therapy): Reassure Program for Patients Using Symbicort Turbuhaler as Maintenance and Reliever Therapy in Korean Clinical Practice
- ClinicalTrials.gov ID
- NCT00523679
- Acronym / sponsor ID
- SMART / NIS-RKR-SYM-2007/1
- Conditions
- Asthma
- Keywords
- Asthma, Symbicort, SMART, inhaler, compliance, Naturalistic, Observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Study completion
- Jul 2008 (actual)
- First posted
- 31 Aug 2007 (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.
The purpose of this study is to investigate the extent of Symbicort use in patients prescribed Symbicort as maintenance and reliever therapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospital Outpatient Clinics
Key inclusion criteria (1 listed)
- Asthma patients prescribed Symbicort as maintenance and reliever therapy, according to the label, before inclusion in this program.
Key exclusion criteria (1 listed)
- Since this programme intends to describe Symbicort use in routine clinical practice when prescribed as Symbicort maintenance and reliever therapy, there are no programme specific exclusion criteria, other than: involvement in the planning and conduct of the programme (applies to both AstraZeneca staff or staff at the investigational site)
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
Not reported in the source record.
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 13 Jul 2009.
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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.
Joon-Woo Bahn study director
AstraZeneca Korea
3 sites 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 3 sites in South Korea.
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 1 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 13 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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.
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 13 Jul 2009.