SHARE - Symbicort and Health Economics in a Real Life Evaluation - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00259766

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: Budesonide Drug: Formoterol Drug: Terbutaline	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Terbutaline Terbutaline sulfate Formoterol fumarate Budesonide Arformoterol Formoterol Symbicort Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	1970
Study Start Date:	April 2004
Study Completion Date:	May 2007

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259766

Show 108 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Symbicort Medical Science Director, MD

AstraZeneca

More Information

No publications provided

Study ID Numbers:	D5890L00001, SHARE
Study First Received:	November 25, 2005
Last Updated:	March 26, 2009
ClinicalTrials.gov Identifier:	NCT00259766 History of Changes
Health Authority:	Sweden: Medical Products Agency

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Bronchial Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Hormones
Adrenergic Agonists
Terbutaline
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases

Tocolytic Agents
Therapeutic Uses
Formoterol
Immune System Diseases
Adrenergic beta-Agonists
Sympathomimetics
Budesonide
Asthma
Anti-Asthmatic Agents
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010