Real Life Effectiveness in Asthma of Symbicort Single Inhaler Therapy (RELEASE)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00319306
First received: April 27, 2006
Last updated: March 16, 2009
Last verified: March 2009
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Budesonide/formoterol
Device: Symbicort® Turbohaler®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Real Life Effectiveness in Asthma of Symbicort Single Inhaler Therapy

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 Measures:
  • Change in forced expiratory volume in one second (FEV1)
  • Change in peak expiratory flow (PEF)
  • Patient Reported Outcomes: AQLQ(S), SATQ, RCP-3 scores

Estimated Enrollment: 550
Study Start Date: September 2005
Study Completion Date: December 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00319306

  Hide Study Locations
Locations
United Kingdom
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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Middlesborough, 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
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Iain Small, MD General Practitioner
Study Director: AstraZeneca UK Medical Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00319306     History of Changes
Other Study ID Numbers: D5890L00012, RELEASE
Study First Received: April 27, 2006
Last Updated: March 16, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Respiratory Tract Diseases
Bronchial Diseases
Anti-asthmatic agents
Anti-asthmatic drugs
Bronchodilators

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Symbicort
Anti-Asthmatic Agents
Pharmacologic Actions
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014