Real Life Effectiveness in Asthma of Symbicort Single Inhaler Therapy
RELEASE
2 other identifiers
interventional
550
1 country
59
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 asthma
Started Sep 2005
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 27, 2006
CompletedFirst Posted
Study publicly available on registry
April 27, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedMarch 17, 2009
March 1, 2009
April 27, 2006
March 16, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (59)
Research Site
Fowey, Cornwall, United Kingdom
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Hove, East Sussex, United Kingdom
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Ilford, Essex, United Kingdom
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Glenrothes, Fife, United Kingdom
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Dartford, Kent, United Kingdom
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Airdrie, Lanarkshire, United Kingdom
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Hamilton, Lanarkshire, United Kingdom
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Doncaster, North Yorkshire, United Kingdom
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Cookstown, Northern Ireland, United Kingdom
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Downpatrick, Northern Ireland, United Kingdom
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Barry, South Glamorgan, United Kingdom
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Chase Terrace, Staffordshire, United Kingdom
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East Horsley, Surrey, United Kingdom
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Crawley, West Sussex, United Kingdom
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Box, Wiltshire, United Kingdom
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Bradford-on-Avon, Wiltshire, United Kingdom
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Ashford, United Kingdom
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Atherstone, United Kingdom
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Ayrshire, United Kingdom
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Bath, United Kingdom
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Blackpool, United Kingdom
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Bolton, United Kingdom
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Cardiff, United Kingdom
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Carrickfergus, United Kingdom
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Cheshire, United Kingdom
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Chesterfield, United Kingdom
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Coventry, United Kingdom
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Dundee, United Kingdom
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Ellesmere Port, United Kingdom
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Fife, United Kingdom
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Glasgow, United Kingdom
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Harrow, United Kingdom
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Larne, United Kingdom
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Leeds, United Kingdom
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Middlesbrough, United Kingdom
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Newcastle, United Kingdom
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Newtownabbey, United Kingdom
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Peterhead, United Kingdom
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Pontypridd, United Kingdom
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Reading, United Kingdom
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Rugby, United Kingdom
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Rutherglen, United Kingdom
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Sandy, United Kingdom
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Sheffield, United Kingdom
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Stafford, United Kingdom
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Stevenage, United Kingdom
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Stockport, United Kingdom
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Sunbury-on-Thames, United Kingdom
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Sutton Coldfield, United Kingdom
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Tilehurst, United Kingdom
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Tonbridge, United Kingdom
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Trowbridge, United Kingdom
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Vale of Glamorgan, United Kingdom
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Warminster, United Kingdom
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Watford, United Kingdom
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Wells-next-the-Sea, United Kingdom
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Westbury, United Kingdom
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Woking, United Kingdom
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Yaxley, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Iain Small, MD
General Practitioner
- STUDY DIRECTOR
AstraZeneca UK Medical Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 27, 2006
First Posted
April 27, 2006
Study Start
September 1, 2005
Study Completion
December 1, 2006
Last Updated
March 17, 2009
Record last verified: 2009-03