AsthmaNCT00782314
Evaluating the Symbicort Turbuhaler (Formoterol/Budesonide) Maintenance and Reliever Therapy for Asthma in Daily Practice
An observational study of Asthma, run by AstraZeneca at 24 sites in Slovenia.
Trial summary
We want to evaluate efficacy of Symbicort® Turbuhaler® (formoterol/budesonide) therapy for asthma in real life conditions. For this purpose we will include both patients that are treated with Symbicort® Turbuhaler® the "classical" maintenance only treatment approach as well as those treated with the SMART approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- How many people
- 400 participants
- Where
- 24 sitesSlovenia
- Study dates
- Apr 2008to Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients visiting pulmologist's office
Who may be able to join
- patients diagnosed with persistent asthma treated with Symbicort® Turbuhaler® in line with its label
- non-pregnant females
- existing maintenance only treatment with Symbicort® Turbuhaler® 80 μg/4,5 μg, 160 μg/4,5 μg or 320 μg/9 μg for at least 1 month
- existing SMART treatment with Symbicort® Turbuhaler® 80 μg/4,5 μg or 160 μg /4,5 μg for at least 1 month
Who cannot join
- patients not being treated with Symbicort® Turbuhaler®
- patients treated with Symbicort® Turbuhaler® for COPD
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Slovenia24 sites
Research Site
Celje, Urban Municipality of Celje
Research Site
Domžale, Municipality of Domžale
Research Site
Dvorec Sela, Dvorec Sela
Research Site
Grosuplje, Municipality of Grosuplje
Research Site
Idrija, Municipality of Idrija
Research Site
Izola, Municipality of Izola
Research Site
Jesenice, Municipality of Jesenice
Research Site
Kamnik-Duplica, Kamnik-Duplica
Research Site
Kranj, Urban Municipality of Kranj
Research Site
Litija, Municipality of Litija
Research Site
Ljubljana, Ljubljana
Research Site
Lucija, Lucija
Research Site
Maribor, Urban Municipality of Maribor
Research Site
Murska Sobota, Urban Municipality of Murska Sobota
Research Site
Novo Mesto, Urban Municipality of Novo Mesto
Research Site
Ptuj, Ptuja
Research Site
Ravne na Koroskem, Municipality of Ravne na Koroškem
Research Site
Sežana, Municipality of Sežana
Research Site
Slovenj Gradec, Urban Municipality of Slovenj Gradec
Research Site
Slovenska Bistrica, Municipality of Slovenska Bistrica
Research Site
Topolšica, Topolsica
Research Site
Velenje, Urban Municipality of Velenje
Research Site
Vrhnika, Municipality of Vrhnika
Research Site
Zagorje, Zagorje
About this study
We want to evaluate efficacy of Symbicort® Turbuhaler® (formoterol/budesonide) therapy for asthma in real life conditions. For this purpose we will include both patients that are treated with Symbicort® Turbuhaler® the "classical" maintenance only treatment approach as well as those treated with the SMART approach.
- Conditions
- Asthma
- Keywords
- asthma, SMART, Symbicort Turbuhaler, asthma control
- 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 |
|---|---|---|
| 1 | patients with maintenance only treatment with Symbicort Turbuhaler for at least 1 month | |
| 2 | patients with SMART treatment with Symbicort Turbuhaler for at least 1 month |
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine the efficacy of both possible treatment approaches with Symbicort® Turbuhaler®, measured by asthma control
Measured: three times: 0, 3, 6 months after inclusion
Secondary outcomes (1)
to determine the number of maintenance and reliever inhalations of Symbicort® Turbuhaler®, as well as the concomitant usage of a separate reliever inhaler even in the case of SMART treatment approach
Measured: three times: 0, 3, 6 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startApr 2008
- Study completionApr 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Igor Koren, MD, MSc, Principal investigator, Radix - medicinske storitve, Igor Koren s.p.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782314
- Sponsor's protocol ID
- NIS-RSI-SYM-2008/1
- Status last verified
- Jul 2009
- First submitted
- 29 Oct 2008
- Last updated
- 24 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Symbicort Turbuhaler (Formoterol/Budesonide) Maintenance and Reliever Therapy for Asthma in Daily Practice
- ClinicalTrials.gov ID
- NCT00782314
- Acronym / sponsor ID
- NIS-RSI-SYM-2008/1
- Conditions
- Asthma
- Keywords
- asthma, SMART, Symbicort Turbuhaler, asthma control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Study completion
- Apr 2009 (actual)
- First posted
- 31 Oct 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.
We want to evaluate efficacy of Symbicort® Turbuhaler® (formoterol/budesonide) therapy for asthma in real life conditions. For this purpose we will include both patients that are treated with Symbicort® Turbuhaler® the "classical" maintenance only treatment approach as well as those treated with the SMART approach.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –patients with maintenance only treatment with Symbicort Turbuhaler for at least 1 month |
| 2 | – | –patients with SMART treatment with Symbicort Turbuhaler for at least 1 month |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients visiting pulmologist's office
Key inclusion criteria (4 listed)
- patients diagnosed with persistent asthma treated with Symbicort® Turbuhaler® in line with its label
- non-pregnant females
- existing maintenance only treatment with Symbicort® Turbuhaler® 80 μg/4,5 μg, 160 μg/4,5 μg or 320 μg/9 μg for at least 1 month
- existing SMART treatment with Symbicort® Turbuhaler® 80 μg/4,5 μg or 160 μg /4,5 μg for at least 1 month
Key exclusion criteria (2 listed)
- patients not being treated with Symbicort® Turbuhaler®
- patients treated with Symbicort® Turbuhaler® for COPD
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
to determine the efficacy of both possible treatment approaches with Symbicort® Turbuhaler®, measured by asthma control
Time frame: three times: 0, 3, 6 months after inclusion
1 secondary outcome
to determine the number of maintenance and reliever inhalations of Symbicort® Turbuhaler®, as well as the concomitant usage of a separate reliever inhaler even in the case of SMART treatment approach
Time frame: three times: 0, 3, 6 months after inclusion
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 24 Jul 2009.
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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.
Igor Koren, MD, MSc principal investigator
Radix - medicinske storitve, Igor Koren s.p.
24 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 24 sites in Slovenia.
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 4 inclusion and 2 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 24 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Slovenia. 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?
to determine the efficacy of both possible treatment approaches with Symbicort® Turbuhaler®, measured by asthma control (time frame: three times: 0, 3, 6 months after inclusion). 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 24 Jul 2009.