Clinical trial NCT00319306: Real Life Effectiveness in Asthma of Symbicort Single Inhaler Therapy
Official title: Real Life Effectiveness in Asthma of Symbicort Single Inhaler Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Respiratory Tract Diseases
Bronchial Diseases
Anti-asthmatic agents
Anti-asthmatic drugs
Bronchodilators
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-04-27
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
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.
Secondary outcomes:
measure: Change in forced expiratory volume in one second (FEV1)
measure: Change in peak expiratory flow (PEF)
measure: Patient Reported Outcomes: AQLQ(S), SATQ, RCP-3 scores
Other outcomes:
Locations:
city: Fowey
country: United Kingdom
facility: Research Site
state: Cornwall
city: Hove
country: United Kingdom
facility: Research Site
state: East Sussex
city: Ilford
country: United Kingdom
facility: Research Site
state: Essex
city: Glenrothes
country: United Kingdom
facility: Research Site
state: Fife
city: Dartford
country: United Kingdom
facility: Research Site
state: Kent
city: Airdrie
country: United Kingdom
facility: Research Site
state: Lanarkshire
city: Hamilton
country: United Kingdom
facility: Research Site
state: Lanarkshire
city: Doncaster
country: United Kingdom
facility: Research Site
state: North Yorkshire
city: Cookstown
country: United Kingdom
facility: Research Site
state: Northern Ireland
city: Downpatrick
country: United Kingdom
facility: Research Site
state: Northern Ireland
city: Barry
country: United Kingdom
facility: Research Site
state: South Glamorgan
city: Chase Terrace
country: United Kingdom
facility: Research Site
state: Staffordshire
city: East Horsley
country: United Kingdom
facility: Research Site
state: Surrey
city: Crawley
country: United Kingdom
facility: Research Site
state: West Sussex
city: Box
country: United Kingdom
facility: Research Site
state: Wiltshire
city: Bradford-On-Avon
country: United Kingdom
facility: Research Site
state: Wiltshire
city: Ashford
country: United Kingdom
facility: Research Site
city: Atherstone
country: United Kingdom
facility: Research Site
city: Ayrshire
country: United Kingdom
facility: Research Site
city: Bath
country: United Kingdom
facility: Research Site
city: Blackpool
country: United Kingdom
facility: Research Site
city: Bolton
country: United Kingdom
facility: Research Site
city: Cardiff
country: United Kingdom
facility: Research Site
city: Carrickfergus
country: United Kingdom
facility: Research Site
city: Cheshire
country: United Kingdom
facility: Research Site
city: Chesterfield
country: United Kingdom
facility: Research Site
city: Coventry
country: United Kingdom
facility: Research Site
city: Dundee
country: United Kingdom
facility: Research Site
city: Ellesmere Port
country: United Kingdom
facility: Research Site
city: Fife
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Harrow
country: United Kingdom
facility: Research Site
city: Larne
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: Middlesborough
country: United Kingdom
facility: Research Site
city: Newcastle
country: United Kingdom
facility: Research Site
city: Newtownabbey
country: United Kingdom
facility: Research Site
city: Peterhead
country: United Kingdom
facility: Research Site
city: Pontypridd
country: United Kingdom
facility: Research Site
city: Reading
country: United Kingdom
facility: Research Site
city: Rugby
country: United Kingdom
facility: Research Site
city: Rutherglen
country: United Kingdom
facility: Research Site
city: Sandy
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
city: Stafford
country: United Kingdom
facility: Research Site
city: Stevenage
country: United Kingdom
facility: Research Site
city: Stockport
country: United Kingdom
facility: Research Site
city: Sunbury on Thames
country: United Kingdom
facility: Research Site
city: Sutton Coldfield
country: United Kingdom
facility: Research Site
city: Tilehurst
country: United Kingdom
facility: Research Site
city: Tonbridge
country: United Kingdom
facility: Research Site
city: Trowbridge
country: United Kingdom
facility: Research Site
city: Vale of Glamorgan
country: United Kingdom
facility: Research Site
city: Warminster
country: United Kingdom
facility: Research Site
city: Watford
country: United Kingdom
facility: Research Site
city: Wells next the Sea
country: United Kingdom
facility: Research Site
city: Westbury
country: United Kingdom
facility: Research Site
city: Woking
country: United Kingdom
facility: Research Site
city: Yaxley
country: United Kingdom
facility: Research Site
Study officials:
affiliation: General Practitioner
name: Iain Small, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: AstraZeneca UK Medical Director, MD
role: STUDY_DIRECTOR
References: