AsthmaPhase 3RELEASENCT00319306
Real Life Effectiveness in Asthma of Symbicort Single Inhaler Therapy
A Phase 3 study testing Budesonide/formoterol and Symbicort® Turbohaler® in people with Asthma, run by AstraZeneca at 59 sites in United Kingdom.
Trial summary
The purpose of this study is to determine whether patients with asthma are better able to manage and control their symptoms by using one inhaler daily that both prevents as well as treats the symptoms of an asthma exacerbation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Budesonide/formoterol and Symbicort® Turbohaler®
- Type of treatment
- Medical device
- How many people
- 550 participants
- Where
- 59 sitesUnited Kingdom
- Study dates
- Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged over 18
- Confirmed diagnosis of mild to moderate asthma by doctor
- Currently receiving inhaled corticoid-steroid medicine for treatment of asthma and requiring a review of current asthma treatment
Who cannot join
- Women who are pregnant, breast-feeding, or planning pregnancy
- Patients with a history of chronic obstructive pulmonary disease
- Patients using any beta blocker therapy
- Patients receiving steroid tablets or steroid injections
Trial locations and contacts
59 sites in 1 country.
59 sites in 1 country
United Kingdom59 sites
Research Site
Airdrie, Lanarkshire
Research Site
Ashford
Research Site
Atherstone
Research Site
Ayrshire
Research Site
Barry, South Glamorgan
Research Site
Bath
Research Site
Blackpool
Research Site
Bolton
Research Site
Box, Wiltshire
Research Site
Bradford on Avon, Wiltshire
Research Site
Cardiff
Research Site
Carrickfergus
Research Site
Chase Terrace, Staffordshire
Research Site
Cheshire
Research Site
Chesterfield
Research Site
Cookstown, Northern Ireland
Research Site
Coventry
Research Site
Crawley, West Sussex
Research Site
Dartford, Kent
Research Site
Doncaster, North Yorkshire
Research Site
Downpatrick, Northern Ireland
Research Site
Dundee
Research Site
East Horsley, Surrey
Research Site
Ellesmere Port
Research Site
Fife
Research Site
Fowey, Cornwall
Research Site
Glasgow
Research Site
Glenrothes, Fife
Research Site
Hamilton, Lanarkshire
Research Site
Harrow
Research Site
Hove, East Sussex
Research Site
Ilford, Essex
Research Site
Larne
Research Site
Leeds
Research Site
Middlesbrough
Research Site
Newcastle
Research Site
Newtownabbey
Research Site
Peterhead
Research Site
Pontypridd
Research Site
Reading
Research Site
Rugby
Research Site
Rutherglen
Research Site
Sandy
Research Site
Sheffield
Research Site
Stafford
Research Site
Stevenage
Research Site
Stockport
Research Site
Sunbury-on-Thames
Research Site
Sutton Coldfield
Research Site
Tilehurst
Research Site
Tonbridge
Research Site
Trowbridge
Research Site
Vale of Glamorgan
Research Site
Warminster
Research Site
Watford
Research Site
Wells-next-the-Sea
Research Site
Westbury
Research Site
Woking
Research Site
Yaxley
About this study
The purpose of this study is to determine whether patients with asthma are better able to manage and control their symptoms by using one inhaler daily that both prevents as well as treats the symptoms of an asthma exacerbation.
- Conditions
- Asthma
- Being tested
- Budesonide/formoterol, Symbicort® Turbohaler®
- Keywords
- Respiratory Tract Diseases, Bronchial Diseases, Anti-asthmatic agents, Anti-asthmatic drugs, Bronchodilators
- Medical subject headings
- Asthma, Respiratory Tract Diseases, Bronchial Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide/formoterolDrug
Symbicort® Turbohaler®Device
What is being measured
The primary outcome is the main question the study is designed to answer.
In a real life setting, to compare Symbicort® Single Inhaler Therapy with a patient's previous therapy (including low dose ICS), by assessment of the changes in the Asthma Control Questionnaire score in uncontrolled asthmatic patients.
Secondary outcomes (3)
Change in forced expiratory volume in one second (FEV1)
Change in peak expiratory flow (PEF)
Patient Reported Outcomes: AQLQ(S), SATQ, RCP-3 scores
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startSep 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
- Single group
- Masking
- None (open label)
- Enrolment
- 550 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Iain Small, MD, Principal investigator, General PractitionerAstraZeneca UK Medical Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00319306
- Sponsor's protocol ID
- D5890L00012
- Other IDs
- RELEASE
- Acronym
- RELEASE
- Status last verified
- Mar 2009
- First submitted
- 27 Apr 2006
- Last updated
- 17 Mar 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real Life Effectiveness in Asthma of Symbicort Single Inhaler Therapy
- ClinicalTrials.gov ID
- NCT00319306
- Acronym / sponsor ID
- RELEASE / D5890L00012
- Conditions
- Asthma
- Keywords
- Respiratory Tract Diseases, Bronchial Diseases, Anti-asthmatic agents, Anti-asthmatic drugs, Bronchodilators
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Study completion
- Dec 2006 (actual)
- First posted
- 27 Apr 2006 (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 this study is to determine whether patients with asthma are better able to manage and control their symptoms by using one inhaler daily that both prevents as well as treats the symptoms of an asthma exacerbation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged over 18
- Confirmed diagnosis of mild to moderate asthma by doctor
- Currently receiving inhaled corticoid-steroid medicine for treatment of asthma and requiring a review of current asthma treatment
Key exclusion criteria (4 listed)
- Women who are pregnant, breast-feeding, or planning pregnancy
- Patients with a history of chronic obstructive pulmonary disease
- Patients using any beta blocker therapy
- Patients receiving steroid tablets or steroid injections
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 | Drug | – |
| Symbicort® Turbohaler® | Device | – |
Primary outcome
In a real life setting, to compare Symbicort® Single Inhaler Therapy with a patient's previous therapy (including low dose ICS), by assessment of the changes in the Asthma Control Questionnaire score in uncontrolled asthmatic patients.
3 secondary outcomes
Change in forced expiratory volume in one second (FEV1)
Change in peak expiratory flow (PEF)
Patient Reported Outcomes: AQLQ(S), SATQ, RCP-3 scores
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 17 Mar 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.
Iain Small, MD principal investigator
General Practitioner
AstraZeneca UK Medical Director, MD study director
AstraZeneca
59 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 and Symbicort® Turbohaler® in people with Asthma, run by AstraZeneca at 59 sites 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 3 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 17 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites 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.
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?
In a real life setting, to compare Symbicort® Single Inhaler Therapy with a patient's previous therapy (including low dose ICS), by assessment of the changes in the Asthma Control Questionnaire score in uncontrolled asthmatic patients.. 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 17 Mar 2009.