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SHARE - Symbicort and Health Economics in a Real Life Evaluation

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ClinicalTrials.gov Identifier: NCT00259766
Recruitment Status : Completed
First Posted : December 1, 2005
Last Update Posted : January 24, 2011
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Drug: Budesonide Drug: Formoterol Drug: Terbutaline Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1970 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2004
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma


Intervention Details:
  • Drug: Budesonide
    Other Name: Symbicort
  • Drug: Formoterol
  • Drug: Terbutaline


Primary Outcome Measures :
  1. 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 :
  1. Number of days patients or assistant persons are absent from work due to patient's asthma
  2. Number of exacerbations and treatment failures


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00259766


Locations
Show Show 108 study locations
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: AstraZeneca Symbicort Medical Science Director, MD AstraZeneca

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ClinicalTrials.gov Identifier: NCT00259766    
Other Study ID Numbers: D5890L00001
SHARE
First Posted: December 1, 2005    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Terbutaline
Formoterol Fumarate
Budesonide, Formoterol Fumarate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Sympathomimetics