AsthmaNCT00946452
Symbicort SMART Satisfaction From Patient Perspective 2009
An observational study of Asthma, run by AstraZeneca at 1 site in Malaysia.
Trial summary
To characterize the level of asthma control and patient satisfaction amongst diagnosed asthma sufferers who are currently receiving Symbicort Maintenance and Reliever Therapy (SMART) in Malaysia. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Asthma
- How many people
- 205 participants
- Where
- 1 siteMalaysia
- Study dates
- Aug 2009to Jan 2010
- 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 59 years
- All sexes
- No healthy volunteers
- Adult
Study population: Primary care clinic
Who may be able to join
- Have been prescribed Symbicort SMART (1 or 2 inhalation twice daily) by their Dr's for the past 3 months
- Informed consent
Who cannot join
- Symbicort SMART treatment < 3 months
- Patients requiring short courses of oral steroids more than twice in a month
Trial locations and contacts
1 site in 1 country.
About this study
To characterize the level of asthma control and patient satisfaction amongst diagnosed asthma sufferers who are currently receiving Symbicort Maintenance and Reliever Therapy (SMART) in Malaysia.
- Conditions
- Asthma
- Keywords
- Control, Satisfaction
- Medical subject headings
- Asthma, Personal Satisfaction
What is being measured
The primary outcome is the main question the study is designed to answer.
Score level of Satisfaction in Asthma Treatment Questionnaire (SATQ)
Measured: After 3 months on SMART - once
Score level of Asthma Control Test (ACT)
Measured: After 3 months on SMART - once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionJan 2010
- Study completionJan 2010
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
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Liam Chong Kin, Professor, Principal investigator, UMMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946452
- Sponsor's protocol ID
- NIS-RMY-SYM-2009/1
- Status last verified
- Mar 2010
- First submitted
- 24 Jul 2009
- Last updated
- 18 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symbicort SMART Satisfaction From Patient Perspective 2009
- ClinicalTrials.gov ID
- NCT00946452
- Acronym / sponsor ID
- NIS-RMY-SYM-2009/1
- Conditions
- Asthma
- Keywords
- Control, Satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 27 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.
To characterize the level of asthma control and patient satisfaction amongst diagnosed asthma sufferers who are currently receiving Symbicort Maintenance and Reliever Therapy (SMART) in Malaysia.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Primary care clinic
Key inclusion criteria (2 listed)
- Have been prescribed Symbicort SMART (1 or 2 inhalation twice daily) by their Dr's for the past 3 months
- Informed consent
Key exclusion criteria (2 listed)
- Symbicort SMART treatment < 3 months
- Patients requiring short courses of oral steroids more than twice in a month
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
Score level of Satisfaction in Asthma Treatment Questionnaire (SATQ)
Time frame: After 3 months on SMART - once
Score level of Asthma Control Test (ACT)
Time frame: After 3 months on SMART - once
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 18 Mar 2010.
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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.
Liam Chong Kin, Professor principal investigator
UMMC
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 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 18 Mar 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.
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?
Score level of Satisfaction in Asthma Treatment Questionnaire (SATQ) (time frame: After 3 months on SMART - once). 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 18 Mar 2010.