Bronchial AsthmaSURENCT01232348
Symbicort Turbuhaler 30/60 Clinical Experience Investigation
An observational study of Bronchial Asthma, run by AstraZeneca at 47 sites in Japan.
Trial summary
The purpose of this study is to confirm the safety (ADR related to beta stimulant drugs, unexpected ADRs) and efficacy of Symbicort in daily practice and the control status on bronchial asthma and Patient satisfaction Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bronchial Asthma
- How many people
- 3,643 participants
- Where
- 47 sitesJapan
- Study dates
- Jan 2010to Oct 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated with Symbicort for the first time due to bronchial asthma
Who may be able to join
- Patients treated with Symbicort for the first time due to bronchial asthma
Who cannot join
- -
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
Japan47 sites
Research Site
Akita, Akita
Research Site
Aomori, Aomori
Research Site
Chiba, Chiba
Research Site
Ehime, Ehime
Research Site
Fukui-shi, Fukui
Research Site
Fukuoka, Fukuoka
Research Site
Fukushima, Fukushima
Research Site
Gifu, Gifu
Research Site
Gunma, Gunma
Research Site
Hiroshima, Hiroshima
Research Site
Hokkaido, Hokkaido
Research Site
Hyogo, Hyōgo
Research Site
Ibaraki, Ibaraki
Research Site
Ishikawa, Ishikawa-ken
Research Site
Kagawa, Kagawa-ken
Research Site
Kagoshima, Kagoshima-ken
Research Site
Kanagawa, Kanagawa
Research Site
Kochi, Kochi
Research Site
Kumamoto, Kumamoto
Research Site
Kyoto, Kyoto
Research Site
Miemachi, Mie-ken
Research Site
Miyagi, Miyagi
Research Site
Miyazaki, Miyazaki
Research Site
Nagano, Nagano
Research Site
Nagasaki, Nagasaki
Research Site
Nara, Nara
Research Site
Niigata, Niigata
Research Site
Numakunai, Iwate
Research Site
Ōita, Oita Prefecture
Research Site
Okayama, Okayama-ken
Research Site
Okazaki, Aichi-ken
Research Site
Okinawa, Okinawa
Research Site
Osaka, Osaka
Research Site
Saga, Saga-ken
Research Site
Saitama, Saitama
Research Site
Shiga, Shiga
Research Site
Shimane, Shimane
Research Site
Shizuoka, Shizuoka
Research Site
Tochigi, Tochigi
Research Site
Tokushima, Tokushima
Research Site
Tokyo, Tokyo
Research Site
Tottori-shi, Tottori
Research Site
Toyama, Toyama
Research Site
Wakayama, Wakayama
Research Site
Yamagata, Yamagata
Research Site
Yamaguchi, Yamaguchi
Research Site
Yamanashi, Yamanashi
About this study
The purpose of this study is to confirm the safety (ADR related to beta stimulant drugs, unexpected ADRs) and efficacy of Symbicort in daily practice and the control status on bronchial asthma and Patient satisfaction
- Conditions
- Bronchial Asthma
- Keywords
- bronchial asthma, 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 |
|---|---|---|
| Symbicort | Those with an exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Measured: Range of 12 weeks
Secondary outcomes (2)
The level of asthma control
Measured: Range of 12 weeks
The level of patient satisfaction with Symbicort
Measured: Range of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startJan 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial 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
- Time perspective
- Prospective
- Enrolment
- 3,643 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoshida Shigeru, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232348
- Sponsor's protocol ID
- D589IL00001
- Acronym
- SURE
- Status last verified
- Dec 2011
- First submitted
- 31 Oct 2010
- Last updated
- 7 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symbicort Turbuhaler 30/60 Clinical Experience Investigation
- ClinicalTrials.gov ID
- NCT01232348
- Acronym / sponsor ID
- SURE / D589IL00001
- Conditions
- Bronchial Asthma
- Keywords
- bronchial asthma, Symbicort
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,643 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 2 Nov 2010 (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 confirm the safety (ADR related to beta stimulant drugs, unexpected ADRs) and efficacy of Symbicort in daily practice and the control status on bronchial asthma and Patient satisfaction
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symbicort | – | –Those with an exposure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated with Symbicort for the first time due to bronchial asthma
Key inclusion criteria (1 listed)
- Patients treated with Symbicort for the first time due to bronchial asthma
Key exclusion criteria (1 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
Incidence of Adverse Events
Time frame: Range of 12 weeks
2 secondary outcomes
The level of asthma control
Time frame: Range of 12 weeks
The level of patient satisfaction with Symbicort
Time frame: Range of 12 weeks
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 7 Dec 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.
Yoshida Shigeru, MD study director
AstraZeneca
47 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchial Asthma, run by AstraZeneca at 47 sites in Japan.
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 7 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in Japan. 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?
Incidence of Adverse Events (time frame: Range of 12 weeks). 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 7 Dec 2011.