Real Life Effectiveness in Asthma of Symbicort Single Inhaler Therapy

Condition(s) targeted: Asthma

Intervention: Budesonide/formoterol (Drug); Symbicort® Turbohaler® (Device)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Iain Small, MD, Principal Investigator, Affiliation: General Practitioner
AstraZeneca UK Medical Director, MD, Study Director, Affiliation: AstraZeneca

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.

Official title: Real Life Effectiveness in Asthma of Symbicort Single Inhaler Therapy

Study design: Treatment, Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study

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.

Secondary outcome:

Change in forced expiratory volume in one second (FEV1)

Change in peak expiratory flow (PEF)

Patient Reported Outcomes: AQLQ(S), SATQ, RCP-3 scores

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Research Site, Ashford, United Kingdom

Research Site, Atherstone, United Kingdom

Research Site, Ayrshire, United Kingdom

Research Site, Bath, United Kingdom

Research Site, Blackpool, United Kingdom

Research Site, Bolton, United Kingdom

Research Site, Cardiff, United Kingdom

Research Site, Carrickfergus, United Kingdom

Research Site, Cheshire, United Kingdom

Research Site, Chesterfield, United Kingdom

Research Site, Coventry, United Kingdom

Research Site, Dundee, United Kingdom

Research Site, Ellesmere Port, United Kingdom

Research Site, Fife, United Kingdom

Research Site, Glasgow, United Kingdom

Research Site, Harrow, 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, United Kingdom

Research Site, Fowey, Cornwall, United Kingdom

Research Site, Hove, East Sussex, United Kingdom

Research Site, Ilford, Essex, United Kingdom

Research Site, Glenrothes, Fife, United Kingdom

Research Site, Dartford, Kent, United Kingdom

Research Site, Airdrie, Lanarkshire, United Kingdom

Research Site, HAMILTON, Lanarkshire, United Kingdom

Research Site, Doncaster, North Yorkshire, United Kingdom

Research Site, Cookstown, Northern Ireland, United Kingdom

Research Site, Downpatrick, Northern Ireland, United Kingdom

Research Site, Barry, South Glamorgan, United Kingdom

Research Site, Chase Terrace, Staffordshire, United Kingdom

Research Site, East Horsley, Surrey, United Kingdom

Research Site, Crawley, West Sussex, United Kingdom

Research Site, Box, Wiltshire, United Kingdom

Research Site, Bradford-On-Avon, Wiltshire, United Kingdom

Starting date: September 2005
Last updated: March 27, 2007