AsthmaNCT00800241
Budesonide/Formoterol for Maintenance and Reliever Therapy Among Asthma Patients in Thailand
An observational study of Asthma, run by AstraZeneca at 14 sites in Thailand.
Trial summary
The purpose of this study is to determine the incidence of misuse, i.e., over-use and under-use, of Budesonide/formoterol for maintenance and reliever therapy in usual-care setting. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- How many people
- 1,020 participants
- Where
- 14 sitesThailand
- Study dates
- May 2009to Nov 2009
- 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: Patient aged 12 years or older who established persistent asthma and currently treated with Symbicort SMART for 3 months or longer.
Who may be able to join
- Established persistent asthma
- Currently treated with Symbicort SMART for 3 months or longer
Who cannot join
- currently participating or have participated in a study with an investigational compound within the last 30 days
- current diagnosis of chronic obstructive pulmonary disease (COPD)
- smoked more than 10 pack-year
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Thailand14 sites
Research Site
Buriram
Research Site
Chanthaburi
Research Site
Chiang Mai
Research Site
Mahasarakham
Research Site
Nakhon Phanom
Research Site
Nakhon Srithammarat
Research Site
Nakhonpathom
Research Site
Phatthalung
Research Site
Phitsanulok
Research Site
Rayong
Research Site
Roi Et
Research Site
Samutsakhon
Research Site
Surat Thani
Research Site
Trang
About this study
Official title: Budesonide/Formoterol for Maintenance and Reliever Therapy: A Medication Use Evaluation Among Persistent Asthma Patients in General Practice in Thailand
The purpose of this study is to determine the incidence of misuse, i.e., over-use and under-use, of Budesonide/formoterol for maintenance and reliever therapy in usual-care setting.
- Conditions
- Asthma
- Keywords
- Asthma, Symbicort SMART, Thai patient eligibility, Persistent asthma
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of budesonide/formoterol use per patient
Measured: On the survey date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2008 (estimated)
- Study startMay 2009
- Study completionNov 2009
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
- Time perspective
- Retrospective
- Enrolment
- 1,020 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bandit Thinkhamrop, PhD., Principal investigator, Department of Biostatistics and Demography, Faculty of Public Health, Khon Kaen UniversityWatchara Boonsawat, MD, PhD, Principal investigator, Department of Medicine, Faculty of Medicine, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800241
- Sponsor's protocol ID
- NIS-RTH-SYM-2008/1
- Status last verified
- Dec 2010
- First submitted
- 1 Dec 2008
- Last updated
- 3 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Budesonide/Formoterol for Maintenance and Reliever Therapy: A Medication Use Evaluation Among Persistent Asthma Patients in General Practice in Thailand
- ClinicalTrials.gov ID
- NCT00800241
- Acronym / sponsor ID
- NIS-RTH-SYM-2008/1
- Conditions
- Asthma
- Keywords
- Asthma, Symbicort SMART, Thai patient eligibility, Persistent asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,020 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Study completion
- Nov 2009 (actual)
- First posted
- 2 Dec 2008 (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 determine the incidence of misuse, i.e., over-use and under-use, of Budesonide/formoterol for maintenance and reliever therapy in usual-care setting.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient aged 12 years or older who established persistent asthma and currently treated with Symbicort SMART for 3 months or longer.
Key inclusion criteria (2 listed)
- Established persistent asthma
- Currently treated with Symbicort SMART for 3 months or longer
Key exclusion criteria (3 listed)
- currently participating or have participated in a study with an investigational compound within the last 30 days
- current diagnosis of chronic obstructive pulmonary disease (COPD)
- smoked more than 10 pack-year
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
Number of budesonide/formoterol use per patient
Time frame: On the survey date
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 3 Dec 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.
Bandit Thinkhamrop, PhD. principal investigator
Department of Biostatistics and Demography, Faculty of Public Health, Khon Kaen University
Watchara Boonsawat, MD, PhD principal investigator
Department of Medicine, Faculty of Medicine, Khon Kaen University
14 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 14 sites in Thailand.
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 3 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 3 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 14 sites in Thailand. 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?
Number of budesonide/formoterol use per patient (time frame: On the survey date). 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 3 Dec 2010.