SHARE - Symbicort and Health Economics in a Real Life Evaluation

January 21, 2011 updated by: AstraZeneca

Symbicort and Health Economics in a Real Life Evaluation - SHARE - A Randomised, Open-Label, Parallel-Group, Multicentre Study to Assess the Asthma-Related Health-Care Costs, in Ordinary Clinical Practice During 12 Months

The purpose of this study is to compare health-related costs and asthma control in ordinary clinical practice during 12 months for Symbicort® given as a low maintenance dose plus as needed compared to a free combination of Pulmicortâ and Oxis® plus Bricanyl® as needed, and Symbicort fixed dosing plus Bricanyl as needed in asthmatic patients not adequately controlled on inhaled glucocorticosteroids alone.

Study Overview

Status

Completed

Conditions

Asthma

Intervention / Treatment

Study Type

Interventional

Enrollment

1970

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

Sweden
- - Akersberga, Sweden
    - Research Site
  - Alingsas, Sweden
    - Research Site
  - Angelholm, Sweden
    - Research Site
  - Angered, Sweden
    - Research Site
  - Arlov, Sweden
    - Research Site
  - Arvidsjaur, Sweden
    - Research Site
  - Arvika, Sweden
    - Research Site
  - Atvidaberg, Sweden
    - Research Site
  - Bandhagen, Sweden
    - Research Site
  - Boden, Sweden
    - Research Site
  - Borensberg, Sweden
    - Research Site
  - Bro, Sweden
    - Research Site
  - Brunflo, Sweden
    - Research Site
  - Eskilstuna, Sweden
    - Research Site
  - Falun, Sweden
    - Research Site
  - Filipstad, Sweden
    - Research Site
  - Fränsta, Sweden
    - Research Site
  - Gagnef, Sweden
    - Research Site
  - Grängesberg, Sweden
    - Research Site
  - Gullspång, Sweden
    - Research Site
  - Gärsnäs, Sweden
    - Research Site
  - Göteborg, Sweden
    - Research Site
  - Haby, Sweden
    - Research Site
  - Halmstad, Sweden
    - Research Site
  - Helsingborg, Sweden
    - Research Site
  - Hisingsbacka, Sweden
    - Research Site
  - Hofors, Sweden
    - Research Site
  - Hollviken, Sweden
    - Research Site
  - Huddinge, Sweden
    - Research Site
  - Höganäs, Sweden
    - Research Site
  - Iggesund, Sweden
    - Research Site
  - Jarfalla, Sweden
    - Research Site
  - Kalmar, Sweden
    - Research Site
  - Karlskoga, Sweden
    - Research Site
  - Karlstad, Sweden
    - Research Site
  - Katrineholm, Sweden
    - Research Site
  - Kil, Sweden
    - Research Site
  - Kinna, Sweden
    - Research Site
  - Klippan, Sweden
    - Research Site
  - Kolmården, Sweden
    - Research Site
  - Kristinehamn, Sweden
    - Research Site
  - Kungalv, Sweden
    - Research Site
  - Kungsbacka, Sweden
    - Research Site
  - Kungsör, Sweden
    - Research Site
  - Landskrona, Sweden
    - Research Site
  - Laxå, Sweden
    - Research Site
  - Leksand, Sweden
    - Research Site
  - Lerum, Sweden
    - Research Site
  - Lidingö, Sweden
    - Research Site
  - Likenäs, Sweden
    - Research Site
  - Limhamn, Sweden
    - Research Site
  - Lindome, Sweden
    - Research Site
  - Linköping, Sweden
    - Research Site
  - Ljungskile, Sweden
    - Research Site
  - Ludvika, Sweden
    - Research Site
  - Luleå, Sweden
    - Research Site
  - Lund, Sweden
    - Research Site
  - Malmo, Sweden
    - Research Site
  - Mariefred, Sweden
    - Research Site
  - Molndal, Sweden
    - Research Site
  - Molnlycke, Sweden
    - Research Site
  - Nacka, Sweden
    - Research Site
  - Norrkoping, Sweden
    - Research Site
  - Norrtälje, Sweden
    - Research Site
  - Nyköping, Sweden
    - Research Site
  - Osby, Sweden
    - Research Site
  - Partille, Sweden
    - Research Site
  - Perstorp, Sweden
    - Reseearch Site
  - Påarp, Sweden
    - Research Site
  - Saltsjo-Bo, Sweden
    - Research Site
  - Sandviken, Sweden
    - Research Site
  - Sjobo, Sweden
    - Research Site
  - Sjuntorp, Sweden
    - Research Site
  - Sollentuna, Sweden
    - Research Site
  - Solna, Sweden
    - Research Site
  - Stenstorp, Sweden
    - Research Site
  - Stenungsund, Sweden
    - Research Site
  - Stockholm, Sweden
    - Research Site
  - Storfors, Sweden
    - Research Site
  - Stugun, Sweden
    - Research Site
  - Sundbyberg, Sweden
    - Research Site
  - Sundsvall, Sweden
    - Research Site
  - Sunne, Sweden
    - Research Site
  - Söderköping, Sweden
    - Research Site
  - Trollhättan, Sweden
    - Research Site
  - Trosa, Sweden
    - Research Site
  - Tyresö, Sweden
    - Research Site
  - Täby, Sweden
    - Research Site
  - Uddevalla, Sweden
    - Research Site
  - Ulricehamn, Sweden
    - Research Site
  - Umeå, Sweden
    - Research Site
  - Uppsala, Sweden
    - Research Site
  - Vallentuna, Sweden
    - Research Site
  - Varberg, Sweden
    - Research Site
  - Varnamo, Sweden
    - Research Site
  - Vellinge, Sweden
    - Research Site
  - Vännäs, Sweden
    - Research Site
  - Väsby, Sweden
    - Research Site
  - Västervik, Sweden
    - Research Site
  - Västerås, Sweden
    - Research Site
  - Västra Frölunda, Sweden
    - Research Site
  - Ystad, Sweden
    - Research Site
  - Ytterby, Sweden
    - Research Site
  - Ånge, Sweden
    - Research Site
  - Årsta, Sweden
    - Research Site
  - Åstorp, Sweden
    - Research Site
  - Ödeshög, Sweden
    - Research Site
  - Örebro, Sweden
    - 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

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Signed informed consent,
asthma,
previously treated with glucocorticosteroids and B2-agonist

Exclusion Criteria:

History of smoking, pregnancy, any significant disease or disorder which may put the patient at risk because of study participation

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: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Asthma-related health-care utilization as measured by total amount of asthma medication purchased and number of contacts with health-care facilities

Secondary Outcome Measures

Outcome Measure
Number of days patients or assistant persons are absent from work due to patient's asthma
Number of exacerbations and treatment failures

Collaborators and Investigators

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

Sponsor

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

April 1, 2004

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

November 25, 2005

First Submitted That Met QC Criteria

November 28, 2005

First Posted (Estimate)

December 1, 2005

Study Record Updates

Last Update Posted (Estimate)

January 24, 2011

Last Update Submitted That Met QC Criteria

January 21, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

D5890L00001
SHARE

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.