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...
Date First Received: November 25, 2005
Last Updated: January 11, 2008
Verified by: AstraZeneca, January 2008
Clinical Trial Phase: Phase 3 | Start Date: April 2004
Overall Status: Completed
Estimated Enrollment: 1970
Brief Summary
Official Title: “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”
Condition Keyword(s):
Intervention(s):
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 Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Study Primary Completion Date: June 2007
Intervention(s) in this Clinical Trial
- Drug: Budesonide
- Drug: Formoterol
- Drug: Terbutaline
Outcome Measures for this Clinical Trial
Primary Measures
- Asthma-related health-care utilization as measured by total amount of asthma medication purchased and number of contacts with health-care facilities
Secondary Measures
- Number of days patients or assistant persons are absent from work due to patient's asthma
- Number of exacerbations and treatment failures
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 12 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: AstraZeneca
Overall Clinical Trial Officials and Contacts
AstraZeneca Symbicort Medical Science Director, MD Study Director AstraZeneca
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00259766
Study ID Number: D5890L00001
ClinicalTrials.gov Identifier: NCT00259766
Health Authority: Sweden: Medical Products Agency
Clinical Trials Authorship and Review
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