Bronchial AsthmaNCT01711840
Clinical Experience Investigation of Symbicort Turbuhaler as Maintenance Therapy and Reliever Therapy
An observational study of Bronchial Asthma, run by AstraZeneca at 47 sites in Japan.
Trial summary
The purpose of the investigation is to confirm the safety of patients receiving Symbicort Turbuhaler as maintenance and reliever therapy ( Symbicort SMART) under the post-marketing actual use. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bronchial Asthma
- How many people
- 2,409 participants
- Where
- 47 sitesJapan
- Study dates
- Nov 2012to Aug 2015
- 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 receiving Symbicort Turbuhaler as maintenance and reliever therapy for the first time due to 'bronchial asthma ',and possibly requiring as-needed inhalations during the observation period
Who may be able to join
- Patients receiving Symbicort Turbuhaler as maintenance and reliever therapy for the first time due to 'bronchial asthma ',and possibly requiring as-needed inhalations during the observation period
Who cannot join
None listed.
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
Japan47 sites
Research Site
Aichi, D589ll00001
Research Site
Akita, D589ll00001
Research Site
Aomori, D589ll00001
Research Site
Chiba, D589ll00001
Research Site
Ehime, D589ll00001
Research Site
Fukui, D589ll00001
Research Site
Fukuoka, D589ll00001
Research Site
Fukushima, D589ll00001
Research Site
Gifu, D589ll00001
Research Site
Gunma, D589ll00001
Research Site
Hiroshima, D589ll00001
Research Site
Hokkaido, D589ll00001
Research Site
Hyōgo, D589ll00001
Research Site
Ibaraki, D589ll00001
Research Site
Ishikawa, D589ll00001
Research Site
Kagawa, D589ll00001
Research Site
Kagoshima, D589ll00001
Research Site
Kanagawa, D589ll00001
Research Site
Kochi, D589ll00001
Research Site
Kumamoto, D589ll00001
Research Site
Kyoto, D589ll00001
Research Site
Mie, D589ll00001
Research Site
Miyagi, D589ll00001
Research Site
Miyazaki, D589ll00001
Research Site
Nagano, D589ll00001
Research Site
Nagasaki, D589ll00001
Research Site
Nara, D589ll00001
Research Site
Niigata, D589ll00001
Research Site
Numakunai, D589ll00001
Research Site
Ōita, D589ll00001
Research Site
Okayama, D589ll00001
Research Site
Okinawa, D589ll00001
Research Site
Osaka, D589ll00001
Research Site
Saga, D589ll00001
Research Site
Saitama, D589ll00001
Research Site
Shiga, D589ll00001
Research Site
Shimane, D589ll00001
Research Site
Shizuoka, D589ll00001
Research Site
Tochigi, D589ll00001
Research Site
Tokushima, D589ll00001
Research Site
Tokyo, D589ll00001
Research Site
Tottori, D589ll00001
Research Site
Toyama, D589ll00001
Research Site
Wakayama, D589ll00001
Research Site
Yamagata, D589ll00001
Research Site
Yamaguchi, D589ll00001
Research Site
Yamanashi, D589ll00001
About this study
Official title: Symbicort Turbuhaler 30/60 Clinical Experience Investigation for Treatment With Symbicort as Maintenance Therapy and as Needed in Response to Symptoms
The purpose of the investigation is to confirm the safety of patients receiving Symbicort Turbuhaler as maintenance and reliever therapy ( Symbicort SMART) under the post-marketing actual use.
Read the detailed description
Symbicort Turbuhaler 30/60 Clinical Experience Investigation for treatment with Symbicort as maintenance therapy and as needed in response to symptoms
- Conditions
- Bronchial Asthma
- Keywords
- Bronchial asthma, Symbicort Turbuhaler
- 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 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event incidence
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionAug 2015
- Study completionAug 2015
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
- 2,409 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shigeru Yoshida, MD, Study director, AstraZeneca KK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711840
- Sponsor's protocol ID
- D589LL00001
- Status last verified
- Jul 2016
- First submitted
- 19 Oct 2012
- Last updated
- 18 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symbicort Turbuhaler 30/60 Clinical Experience Investigation for Treatment With Symbicort as Maintenance Therapy and as Needed in Response to Symptoms
- ClinicalTrials.gov ID
- NCT01711840
- Acronym / sponsor ID
- D589LL00001
- Conditions
- Bronchial Asthma
- Keywords
- Bronchial asthma, Symbicort Turbuhaler
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,409 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 22 Oct 2012 (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 the investigation is to confirm the safety of patients receiving Symbicort Turbuhaler as maintenance and reliever therapy ( Symbicort SMART) under the post-marketing actual use.
Detailed description
Symbicort Turbuhaler 30/60 Clinical Experience Investigation for treatment with Symbicort as maintenance therapy and as needed in response to symptoms
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symbicort | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients receiving Symbicort Turbuhaler as maintenance and reliever therapy for the first time due to 'bronchial asthma ',and possibly requiring as-needed inhalations during the observation period
Key inclusion criteria (1 listed)
- Patients receiving Symbicort Turbuhaler as maintenance and reliever therapy for the first time due to 'bronchial asthma ',and possibly requiring as-needed inhalations during the observation period
Key exclusion criteria (0 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
Adverse event incidence
Time frame: 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 18 Jul 2016.
- CSR SynopsisLink provided by the sponsor.
Related trials for Bronchial Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
Shigeru Yoshida, MD study director
AstraZeneca KK
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 0 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 Jul 2016. 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?
Adverse event incidence (time frame: 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 18 Jul 2016.