Asthma Clinical Trial
— RELEASEOfficial title:
Real Life Effectiveness in Asthma of Symbicort Single Inhaler Therapy
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.
| Status | Completed |
| Enrollment | 550 |
| Est. completion date | December 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Research Site | Airdrie | Lanarkshire |
| United Kingdom | Research Site | Ashford | |
| United Kingdom | Research Site | Atherstone | |
| United Kingdom | Research Site | Ayrshire | |
| United Kingdom | Research Site | Barry | South Glamorgan |
| United Kingdom | Research Site | Bath | |
| United Kingdom | Research Site | Blackpool | |
| United Kingdom | Research Site | Bolton | |
| United Kingdom | Research Site | Box | Wiltshire |
| United Kingdom | Research Site | Bradford-On-Avon | Wiltshire |
| United Kingdom | Research Site | Cardiff | |
| United Kingdom | Research Site | Carrickfergus | |
| United Kingdom | Research Site | Chase Terrace | Staffordshire |
| United Kingdom | Research Site | Cheshire | |
| United Kingdom | Research Site | Chesterfield | |
| United Kingdom | Research Site | Cookstown | Northern Ireland |
| United Kingdom | Research Site | Coventry | |
| United Kingdom | Research Site | Crawley | West Sussex |
| United Kingdom | Research Site | Dartford | Kent |
| United Kingdom | Research Site | Doncaster | North Yorkshire |
| United Kingdom | Research Site | Downpatrick | Northern Ireland |
| United Kingdom | Research Site | Dundee | |
| United Kingdom | Research Site | East Horsley | Surrey |
| United Kingdom | Research Site | Ellesmere Port | |
| United Kingdom | Research Site | Fife | |
| United Kingdom | Research Site | Fowey | Cornwall |
| United Kingdom | Research Site | Glasgow | |
| United Kingdom | Research Site | Glenrothes | Fife |
| United Kingdom | Research Site | Hamilton | Lanarkshire |
| United Kingdom | Research Site | Harrow | |
| United Kingdom | Research Site | Hove | East Sussex |
| United Kingdom | Research Site | Ilford | Essex |
| United Kingdom | Research Site | Larne | |
| United Kingdom | Research Site | Leeds | |
| United Kingdom | Research Site | Middlesborough | |
| United Kingdom | Research Site | Newcastle | |
| United Kingdom | Research Site | Newtownabbey | |
| United Kingdom | Research Site | Peterhead | |
| United Kingdom | Research Site | Pontypridd | |
| United Kingdom | Research Site | Reading | |
| United Kingdom | Research Site | Rugby | |
| United Kingdom | Research Site | Rutherglen | |
| United Kingdom | Research Site | Sandy | |
| United Kingdom | Research Site | Sheffield | |
| United Kingdom | Research Site | Stafford | |
| United Kingdom | Research Site | Stevenage | |
| United Kingdom | Research Site | Stockport | |
| United Kingdom | Research Site | Sunbury on Thames | |
| United Kingdom | Research Site | Sutton Coldfield | |
| United Kingdom | Research Site | Tilehurst | |
| United Kingdom | Research Site | Tonbridge | |
| United Kingdom | Research Site | Trowbridge | |
| United Kingdom | Research Site | Vale of Glamorgan | |
| United Kingdom | Research Site | Warminster | |
| United Kingdom | Research Site | Watford | |
| United Kingdom | Research Site | Wells next the Sea | |
| United Kingdom | Research Site | Westbury | |
| United Kingdom | Research Site | Woking | |
| United Kingdom | Research Site | Yaxley |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Change in forced expiratory volume in one second (FEV1) | |||
| Secondary | Change in peak expiratory flow (PEF) | |||
| Secondary | Patient Reported Outcomes: AQLQ(S), SATQ, RCP-3 scores |
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