AsthmaSYMCONCT00557297
NIS for Patients Using Symbicort Turbuhaler for Maintenance and Reliever Therapy in a Single Inhaler
An observational study of Asthma, run by AstraZeneca at 22 sites in Latvia.
Trial summary
The aim of this non-interventional study is to ensure that patients in routine clinical practice follow given treatment instructions and to evaluate the number of reliever inhalations as well as the number of patient/days with more than 8/12 total inhalations at any day. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- How many people
- 250 participants
- Where
- 22 sitesLatvia
- Study dates
- Oct 2007to Sep 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persistent asthma
- Prior Symbicort Turbuhaler maintenance and reliever therapy in a single inhaler
Who cannot join
None listed.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Latvia22 sites
Research Site
Alūksne
Research Site
Aozkraukle
Research Site
Balvi
Research Site
Cēsis
Research Site
Gulbene
Research Site
Jēkabpils
Research Site
Jumprava
Research Site
Ķekava
Research Site
Krāslava
Research Site
Kuldīga
Research Site
Liepāja
Research Site
Limbaži
Research Site
Līvāni
Research Site
Madona
Research Site
Ogre
Research Site
Preiļi
Research Site
Rēzekne
Research Site
Salacgrīva
Research Site
Saldus
Research Site
Talsi
Research Site
Valniera
Research Site
Ventspils
About this study
The aim of this non-interventional study is to ensure that patients in routine clinical practice follow given treatment instructions and to evaluate the number of reliever inhalations as well as the number of patient/days with more than 8/12 total inhalations at any day. If the number of reliever inhalations and thus the received inhaled glucocorticosteroid dose is not excessive, the safety conclusions from the clinical studies can be extrapolated to real life for better acceptance of SMART (Symbicort Maintenance and Reliever Therapy).
- Conditions
- Asthma
- Keywords
- asthma, SMART, inhaled, glucocorticosteroid, reliever, maintenance, single inhaler
- Medical subject headings
- Asthma, Respiratory Aspiration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2007 (estimated)
- Study startOct 2007
- Study completionSep 2008
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
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00557297
- Sponsor's protocol ID
- D5890L00031
- Acronym
- SYMCO
- Status last verified
- Sep 2008
- First submitted
- 9 Nov 2007
- Last updated
- 25 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIS for Patients Using Symbicort Turbuhaler for Maintenance and Reliever Therapy in a Single Inhaler
- ClinicalTrials.gov ID
- NCT00557297
- Acronym / sponsor ID
- SYMCO / D5890L00031
- Conditions
- Asthma
- Keywords
- asthma, SMART, inhaled, glucocorticosteroid, reliever, maintenance, single inhaler
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Study completion
- Sep 2008 (actual)
- First posted
- 14 Nov 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.
The aim of this non-interventional study is to ensure that patients in routine clinical practice follow given treatment instructions and to evaluate the number of reliever inhalations as well as the number of patient/days with more than 8/12 total inhalations at any day. If the number of reliever inhalations and thus the received inhaled glucocorticosteroid dose is not excessive, the safety conclusions from the clinical studies can be extrapolated to real life for better acceptance of SMART (Symbicort Maintenance and Reliever Therapy).
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Persistent asthma
- Prior Symbicort Turbuhaler maintenance and reliever therapy in a single inhaler
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
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 25 Sep 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
22 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 22 sites in Latvia.
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 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 25 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Latvia. 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 25 Sep 2008.