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

March 16, 2009 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

550

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • 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
    • Cornwall
      • Fowey, Cornwall, United Kingdom
        • Research Site
    • East Sussex
      • Hove, East Sussex, United Kingdom
        • Research Site
    • Essex
      • Ilford, Essex, United Kingdom
        • Research Site
    • Fife
      • Glenrothes, Fife, United Kingdom
        • Research Site
    • Kent
      • Dartford, Kent, United Kingdom
        • Research Site
    • Lanarkshire
      • Airdrie, Lanarkshire, United Kingdom
        • Research Site
      • Hamilton, Lanarkshire, United Kingdom
        • Research Site
    • North Yorkshire
      • Doncaster, North Yorkshire, United Kingdom
        • Research Site
    • Northern Ireland
      • Cookstown, Northern Ireland, United Kingdom
        • Research Site
      • Downpatrick, Northern Ireland, United Kingdom
        • Research Site
    • South Glamorgan
      • Barry, South Glamorgan, United Kingdom
        • Research Site
    • Staffordshire
      • Chase Terrace, Staffordshire, United Kingdom
        • Research Site
    • Surrey
      • East Horsley, Surrey, United Kingdom
        • Research Site
    • West Sussex
      • Crawley, West Sussex, United Kingdom
        • Research Site
    • Wiltshire
      • Box, Wiltshire, United Kingdom
        • Research Site
      • Bradford-On-Avon, Wiltshire, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Iain Small, MD, General Practitioner
  • Study Director: AstraZeneca UK Medical Director, MD, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

April 27, 2006

First Submitted That Met QC Criteria

April 27, 2006

First Posted (Estimate)

April 27, 2006

Study Record Updates

Last Update Posted (Estimate)

March 17, 2009

Last Update Submitted That Met QC Criteria

March 16, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5890L00012
  • RELEASE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma

Clinical Trials on Budesonide/formoterol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe