SHARE - Symbicort and Health Economics in a Real Life Evaluation

Condition(s) targeted: Asthma

Intervention: Budesonide (Drug); Formoterol (Drug); Terbutaline (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Symbicort Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

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.

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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Secondary outcome:

Number of days patients or assistant persons are absent from work due to patient's asthma

Number of exacerbations and treatment failures

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Research Site, Halmstad, Sweden

Research Site, Norrkoping, Sweden

Research Site, Akersberga, Sweden

Research Site, Karlstad, Sweden

Research Site, Sundsvall, Sweden

Research Site, Alingsas, Sweden

Research Site, Ånge, Sweden

Research Site, Angelholm, Sweden

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Starting date: April 2004
Ending date: June 2007
Last updated: January 11, 2008