AsthmaPhase 4SMARTERNCT00576316
Symbicort Maintenance and Reliever Therapy - Experience in Real Life Setting in Malaysia
A Phase 4 study testing Symbicort Turbuhaler 160/4.5 in people with Asthma, run by AstraZeneca at 1 site in Malaysia.
Trial summary
The purpose of the study is to evaluate the satisfaction level of patients using the Symbicort SMART approach for their asthma management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Symbicort Turbuhaler 160/4.5
- How many people
- 201 participants
- Where
- 1 siteMalaysia
- Study dates
- Jan 2008to Nov 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of asthma for past 6 months and treated with inhaled glucocorticosteroids for at least 3 months.
- Patients who asthma is classified as uncontrolled or partially controlled as defined by GINA 2006 guidelines.
Who cannot join
- Patients already on Symbicort SMART treatment.
- Patients who has respiratory tract infection 30 days before study enrolment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Symbicort Maintenance And Reliever Therapy - Experience in Real Life Setting in Malaysia - SMARTER Study
The purpose of the study is to evaluate the satisfaction level of patients using the Symbicort SMART approach for their asthma management.
- Conditions
- Asthma
- Being tested
- Symbicort Turbuhaler 160/4.5
- Keywords
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symbicort Turbuhaler 160/4.5Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Satisfaction With Asthma Treatment Questionnaire (SATQ) Scores From Baseline to the Mean of 3 Months and 6 Months After Patient Was Initially Treated With SMART
Difference/change in SATQ score between baseline and mean of 3 months and 6 months after SMART treatment as analysed by paired t-test. SATQ is a patient reported questionnaire which consists of 26 questions and scored to a scale of 1-7, the higher score indicating a greater level of satisfaction
Measured: 6 months after each patient was initially treated with Symbicort SMART
Secondary outcomes (1)
Changes in Asthma Control Questionnaire (ACQ-5) Score From Baseline to the Mean of 3 Months and 6 Months After Patient Was Initially Treated With SMART
Difference/change in ACQ-5 scores between baseline and mean of 3 months and 6 months after SMART treatment. ACQ-5 is a 5 question patient reported outcome measuring level of asthma control during the past 7 days and it is scored on scale of 0-6. 0 indicates no symptoms and 6 represents severe symptoms
Measured: 6 months after each patient was initially treated with Symbicort SMART
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2007 (estimated)
- Study startJan 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Akhmal Yusof, MD, Study director, AstraZenecaAziah Ahmad Mahayiddin, MD, Principal investigator, Kuala Lumpur Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00576316
- Sponsor's protocol ID
- D5890L00027
- Acronym
- SMARTER
- Status last verified
- Nov 2010
- First submitted
- 17 Dec 2007
- Last updated
- 16 Dec 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symbicort Maintenance And Reliever Therapy - Experience in Real Life Setting in Malaysia - SMARTER Study
- ClinicalTrials.gov ID
- NCT00576316
- Acronym / sponsor ID
- SMARTER / D5890L00027
- Conditions
- Asthma
- Keywords
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Study completion
- Nov 2008 (actual)
- First posted
- 19 Dec 2007 (estimated)
- Results
- Posted 29 Dec 2009
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 the study is to evaluate the satisfaction level of patients using the Symbicort SMART approach for their asthma management.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of asthma for past 6 months and treated with inhaled glucocorticosteroids for at least 3 months.
- Patients who asthma is classified as uncontrolled or partially controlled as defined by GINA 2006 guidelines.
Key exclusion criteria (2 listed)
- Patients already on Symbicort SMART treatment.
- Patients who has respiratory tract infection 30 days before study enrolment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symbicort Turbuhaler 160/4.5 | Drug | – |
Primary outcome
Change in Satisfaction With Asthma Treatment Questionnaire (SATQ) Scores From Baseline to the Mean of 3 Months and 6 Months After Patient Was Initially Treated With SMART
Time frame: 6 months after each patient was initially treated with Symbicort SMART
Difference/change in SATQ score between baseline and mean of 3 months and 6 months after SMART treatment as analysed by paired t-test. SATQ is a patient reported questionnaire which consists of 26 questions and scored to a scale of 1-7, the higher score indicating a greater level of satisfaction
1 secondary outcome
Changes in Asthma Control Questionnaire (ACQ-5) Score From Baseline to the Mean of 3 Months and 6 Months After Patient Was Initially Treated With SMART
Time frame: 6 months after each patient was initially treated with Symbicort SMART
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Akhmal Yusof, MD study director
AstraZeneca
Aziah Ahmad Mahayiddin, MD principal investigator
Kuala Lumpur Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Symbicort Turbuhaler 160/4.5 in people with Asthma, run by AstraZeneca at 1 site in Malaysia.
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 2 inclusion and 2 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 16 Dec 2010. 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 Malaysia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Satisfaction With Asthma Treatment Questionnaire (SATQ) Scores From Baseline to the Mean of 3 Months and 6 Months After Patient Was Initially Treated With SMART (time frame: 6 months after each patient was initially treated with Symbicort SMART). 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 16 Dec 2010.