Bronchial AsthmaNCT00503061
A Pharmaceopidemiological Study in Patients Who Use Symbicort SMART
An observational study of Bronchial Asthma, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
To investigate how common it is that patients using Symibort SMART take high average daily doses that are not considered appropriate by their physician (overuse) or are hospitalised due to their asthma at least partly due to underuse. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bronchial Asthma
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2007to May 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Population comes from Primary Care Clinics and Pulmonary Experts
Who may be able to join
- Asthma diagnosis, patient registered with the prescribing physician for at least one year before the qualifying prescription of Symbicort, prescription of Symbicort SMART after UK launch of the concept
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pharmaceopidemiological Study in Patients Who Use Symbicort Turbuhaler as Maintenance and Reliever Therapy (Symbicort SMART) Capturing Over Use and Under Use Via the General Practice Research Database
To investigate how common it is that patients using Symibort SMART take high average daily doses that are not considered appropriate by their physician (overuse) or are hospitalised due to their asthma at least partly due to underuse.
- Conditions
- Bronchial Asthma
- Keywords
- pharmaceopidemiological, Symbicort SMART, GPRD
- Medical subject headings
- Asthma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2007 (estimated)
- Study startJun 2007
- Primary completionMay 2010
- Study completionMay 2010
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Catriona McMahon, MD, Principal investigator, AZ UK MCTomas Andersson, MD, Study director, AZ R&D Lund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503061
- Sponsor's protocol ID
- D5890C00017
- Other IDs
- GPRD
- Status last verified
- Nov 2010
- First submitted
- 17 Jul 2007
- Last updated
- 1 Dec 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmaceopidemiological Study in Patients Who Use Symbicort Turbuhaler as Maintenance and Reliever Therapy (Symbicort SMART) Capturing Over Use and Under Use Via the General Practice Research Database
- ClinicalTrials.gov ID
- NCT00503061
- Acronym / sponsor ID
- D5890C00017
- Conditions
- Bronchial Asthma
- Keywords
- pharmaceopidemiological, Symbicort SMART, GPRD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 18 Jul 2007 (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 investigate how common it is that patients using Symibort SMART take high average daily doses that are not considered appropriate by their physician (overuse) or are hospitalised due to their asthma at least partly due to underuse.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Population comes from Primary Care Clinics and Pulmonary Experts
Key inclusion criteria (1 listed)
- Asthma diagnosis, patient registered with the prescribing physician for at least one year before the qualifying prescription of Symbicort, prescription of Symbicort SMART after UK launch of the concept
Key exclusion criteria (1 listed)
- None
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
Not reported in the source record.
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 1 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.
Catriona McMahon, MD principal investigator
AZ UK MC
Tomas Andersson, MD study director
AZ R&D Lund
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 Bronchial Asthma, run by AstraZeneca at 1 site in United Kingdom.
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 1 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 United Kingdom. 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.
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 1 Dec 2010.