AsthmaPhase 3NCT00259792
SYMPHONIE - A Comparison of Symbicort Single Inhaler and Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents and Adults
A Phase 3 study testing Budesonide/formoterol Turbuhaler in people with Asthma, run by AstraZeneca at 82 sites in France.
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
- How many people
- 1,000 participants
- Where
- 82 sitesFrance
- Study dates
- Sep 2004to Jan 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
- Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition. Prescribed inhaled GCS at a dose of ³400 µg/day and within the approved label for the relevant drug during the last 3 months prior to Visit 1.
Who cannot join
- Use of any b-blocking agent, including eye-drops, Use of oral GCS as maintenance treatment, A history of smoking ³ 10 pack years (1 pack year = 1 pack (20 cigarettes) per day for one year or equivalent).
Trial locations and contacts
82 sites in 1 country.
82 sites in 1 country
France82 sites
Research Site
Abbeville
Research Site
Agen
Research Site
Ajaccio
Research Site
Albi
Research Site
Alès
Research Site
Ambérieu-en-Bugey
Research Site
Amiens
Research Site
Angers
Research Site
Angoulême
Research Site
Apt
Research Site
Arles
Research Site
Aubagne
Research site
Avignon
Research Site
Avrillé
Research Site
Bastia
Research Site
Bayonne
Research Site
Béthune
Research Site
Béziers
Research Site
Biarritz
Research Site
Blois
Research Site
Bois-Guillaume
Research Site
Bordeaux
Research Site
Boulogne-Billancourt
Research Site
Bourgoin
Research Site
Brest
Research Site
Briey
Research Site
Bron
Research Site
Cabestany
Research Site
Cachan
Research Site
Caen
Research Site
Cagnes-sur-Mer
Research Site
Cambrai
Research Site
Carcassonne
Research Site
Castelnau-le-Lez
Research site
Challans
Research Site
Châlons-en-Champagne
Research Site
Champs-sur-Marne
Research Site
Charleville-Mézières
Research Site
Chelles
Research Site
Cherbourg Octeville
Research Site
Chevilly-Larue
Research Site
Choisy-le-Roi
Research site
Cholet
Research Site
Colmar
Research Site
Cornebarrieu
Research Site
Courbevoie
Research Sites
Créteil
Research Site
Denain
Research Site
Dieppe
Research Site
Dijon
Research Site
Dole
Research Site
Épernay
Research Site
Épinal
Research Site
Ermont
Research Site
Étampes
Research Site
Fécamp
Research Site
Forbach
Research Site
Gournay-sur-Marne
Research Site
Grenoble
Research Site
Hagondange
Research Site
Hazebrouck
Research Site
Hénin-Beaumont
Research Site
Herblay-sur-Seine
Research Site
Hyères
Research Site
Issy-les-Moulineaux
Research Site
Joigny
Research Site
Juan-les-Pins
Research Site
La Roche-sur-Yon
Research site
La Rochelle
Research Site
La Teste-de-Buch
Research Site
Lagardelle-sur-Lèze
Research Site
Le Havre
Research Site
Le Puy-en-Velay
Research site
Lens
Research Site
Les Mureaux
Research Site
Libourne
Research Site
Lille
Research site
Limoges
Research site
Loudéac
Research site
Lunéville
Research Site
Lyon
Research Site
Marcq-en-Barœul
About this study
Official title: A Comparison of Symbicort Single Inhaler and Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents and Adults - a 26-week, Randomised, Open, 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
- 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 TurbuhalerDrug
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 (1)
Number of asthma exacerbations, Mean use of as-needed medication, Prescribed asthma medication, Asthma Control Questionnaire, Satisfaction with Asthma Treatment Questionnaire, Safety: Serious Adverse Events and discontinuations due to adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startSep 2004
- Study completionJan 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
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca France Medical Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259792
- Sponsor's protocol ID
- D5890L00005
- Other IDs
- SYMPHONIE
- Status last verified
- Jan 2011
- First submitted
- 29 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 Symbicort Single Inhaler and Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents and Adults - a 26-week, Randomised, Open, Parallel Group Multicentre Study
- ClinicalTrials.gov ID
- NCT00259792
- Acronym / sponsor ID
- D5890L00005
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Study completion
- Jan 2006 (actual)
- First posted
- 1 Dec 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 (1 listed)
- Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition. Prescribed inhaled GCS at a dose of ³400 µg/day and within the approved label for the relevant drug during the last 3 months prior to Visit 1.
Key exclusion criteria (1 listed)
- Use of any b-blocking agent, including eye-drops, Use of oral GCS as maintenance treatment, A history of smoking ³ 10 pack years (1 pack year = 1 pack (20 cigarettes) per day for one year or equivalent).
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 TurbuhalerAlso: Symbicort | Drug | – |
Primary outcome
Time to first severe asthma exacerbation
1 secondary outcome
Number of asthma exacerbations, Mean use of as-needed medication, Prescribed asthma medication, Asthma Control Questionnaire, Satisfaction with Asthma Treatment Questionnaire, Safety: Serious Adverse Events and discontinuations due to adverse events
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.
Related trials for 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.
AstraZeneca France Medical Director, MD study director
AstraZeneca
82 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Budesonide/formoterol Turbuhaler in people with Asthma, run by AstraZeneca at 82 sites in France.
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 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 82 sites in France. 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.