NCT00319306

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
550

participants targeted

Target at P50-P75 for phase_3 asthma

Timeline
Completed

Started Sep 2005

Geographic Reach
1 country

59 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2006

Completed
Same day until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

March 17, 2009

Status Verified

March 1, 2009

First QC Date

April 27, 2006

Last Update Submit

March 16, 2009

Conditions

Keywords

Respiratory Tract DiseasesBronchial DiseasesAnti-asthmatic agentsAnti-asthmatic drugsBronchodilators

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

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

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MeSH Terms

Conditions

AsthmaRespiratory Tract DiseasesBronchial Diseases

Interventions

Budesonide, Formoterol Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Formoterol FumarateEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBudesonidePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Iain Small, MD

    General Practitioner

    PRINCIPAL INVESTIGATOR
  • AstraZeneca UK Medical Director, MD

    AstraZeneca

    STUDY DIRECTOR

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

Locations