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SHARE - Symbicort and Health Economics in a Real Life Evaluation

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00259766
First received: November 25, 2005
Last updated: January 21, 2011
Last verified: January 2011
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
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
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, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00259766     History of Changes
Other Study ID Numbers: D5890L00001  SHARE 
Study First Received: November 25, 2005
Last Updated: January 21, 2011
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Formoterol Fumarate
Budesonide
Terbutaline
Budesonide, Formoterol Fumarate Drug Combination
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics

ClinicalTrials.gov processed this record on September 27, 2016