AsthmaPhase 3NCT00252824
STYLE - Symbicort Single Inhaler Therapy vs Conventional Therapy in Treatment of Persistent Asthma
A Phase 3 study testing Budesonide/formoterol Turbuhaler vs Conventional Best Asthma Therapy in people with Asthma, run by AstraZeneca at 53 sites in 10 countries.
Trial summary
The purpose of the study is to compare the efficacy of a flexible dose of Symbicort with conventional stepwise treatment according to asthma treatment guidelines in patients with persistent asthma Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Budesonide/formoterol Turbuhaler vs Conventional Best Asthma Therapy
- How many people
- 1,000 participants
- Where
- 53 sitesin 10 countries
- Study dates
- Jul 2005to Dec 2006
- Phase
- Phase 3
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- - Diagnosis of asthma ³ 3 months
- Prescribed daily use of glucocorticosteroids at a dose > 320 mcg/ day for at least 3 months prior to Visit 1
Who cannot join
- Smoking history > 10 pack-years
- Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to inclusion
- Any significant disease or disorder that my jeopardize the safety of the patient.
- Additional inclusion and exclusion criteria will be evaluated by the investigator.
Trial locations and contacts
53 sites in 10 countries.
53 sites in 10 countries
Slovakia13 sites
Research Site
Banská Bystrica
Research Site
Bardejov
Research Site
Bratislava
Research Site
Hlohovec
Research Site
Košice
Research Site
Liptovský Hrádok
Research Site
Malacky
Research Site
Nitra Zobor
Research Site
Partizánske
Research Site
Revúca
Research Site
Senec
Research Site
Topostany
Research Site
Žilina
Czechia8 sites
Research Site
Brno
Research Site
Hradec Králové
Research Site
Jihlava
Research Site
Litomice
Research Site
Ostrava
Research Site
Prague
Research Site
Prostijov
Research Site
Strakonice
Slovenia8 sites
Research Site
Celje
Research Site
Golnik
Research Site
Kamnik
Research Site
Koper
Research Site
Litija
Research Site
Ljubljana
Research Site
Murska Sobota
Research Site
Nova Gorica
Portugal7 sites
Research Site
Aveiro
Research Site
Coimbra
Research Site
Coviha
Research Site
Lisbon
Research Site
Porto
Research Site
Setúbal
Research Site
Vila Nova de Gaia
Greece4 sites
Research Site
Ahens
Research Site
Alexandroup
Research Site
Athens
Research Site
Kavala
Latvia3 sites
Research Site
Daugavpils
Research Site
Riga
Research Site
Rigas Raj
Lithuania3 sites
Research Site
Kaunas
Research Site
Klaipėda
Research Site
Vilnius
About this study
Official title: A Comparison of the Efficacy of Symbicort® Single Inhaler Therapy (Symbicort Turbuhaler® 160/4.5 mg 1 Inhalation b.i.d. Plus As-needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents and Adults - a 26 Weeks, Randomised, Open-label, Parallel-group, Multicentre Study
The purpose of the study is to compare the efficacy of a flexible dose of Symbicort with conventional stepwise treatment according to asthma treatment guidelines in patients with persistent asthma
- Conditions
- Asthma
- Being tested
- Budesonide/formoterol Turbuhaler vs Conventional Best Asthma Therapy
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide/formoterol Turbuhaler vs Conventional Best Asthma TherapyDrug
Also called Symbicort
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first severe asthma exacerbation
Secondary outcomes (7)
Number of asthma exacerbations
Mean use of as-needed medication
Prescribed asthma medication
Asthma Control Questionnaire
Asthma related costs (direct asthma medication, direct non-medication costs and indirect costs)
Safety: Serious Adverse Events and discontinuations due to adverse events
All variables assessed over the 6 months treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startJul 2005
- Study completionDec 2006
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Symbicort Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00252824
- Sponsor's protocol ID
- D5890L00014
- Other IDs
- STYLE
- Status last verified
- Jan 2011
- First submitted
- 10 Nov 2005
- Last updated
- 24 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Efficacy of Symbicort® Single Inhaler Therapy (Symbicort Turbuhaler® 160/4.5 mg 1 Inhalation b.i.d. Plus As-needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents and Adults - a 26 Weeks, Randomised, Open-label, Parallel-group, Multicentre Study
- ClinicalTrials.gov ID
- NCT00252824
- Acronym / sponsor ID
- D5890L00014
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Study completion
- Dec 2006 (actual)
- First posted
- 15 Nov 2005 (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 study is to compare the efficacy of a flexible dose of Symbicort with conventional stepwise treatment according to asthma treatment guidelines in patients with persistent asthma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- - Diagnosis of asthma ³ 3 months
- Prescribed daily use of glucocorticosteroids at a dose > 320 mcg/ day for at least 3 months prior to Visit 1
Key exclusion criteria (4 listed)
- Smoking history > 10 pack-years
- Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to inclusion
- Any significant disease or disorder that my jeopardize the safety of the patient.
- Additional inclusion and exclusion criteria will be evaluated by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budesonide/formoterol Turbuhaler vs Conventional Best Asthma TherapyAlso: Symbicort | Drug | – |
Primary outcome
Time to first severe asthma exacerbation
7 secondary outcomes
Number of asthma exacerbations
Mean use of as-needed medication
Prescribed asthma medication
Asthma Control Questionnaire
Asthma related costs (direct asthma medication, direct non-medication costs and indirect costs)
Safety: Serious Adverse Events and discontinuations due to adverse events
All variables assessed over the 6 months treatment period
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 Jan 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.
AstraZeneca Symbicort Medical Science Director, MD study director
AstraZeneca
53 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Budesonide/formoterol Turbuhaler vs Conventional Best Asthma Therapy in people with Asthma, run by AstraZeneca at 53 sites in 10 countries.
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 4 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 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in Slovakia, Czechia, Slovenia, Portugal, Greece and 5 more countries. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to first severe asthma exacerbation. 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 Jan 2011.