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SYMPHONIE - A Comparison of Symbicort Single Inhaler and Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents and Adults

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ClinicalTrials.gov Identifier: NCT00259792
Recruitment Status : Completed
First Posted : December 1, 2005
Last Update Posted : January 24, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of the study is to compare the efficacy of a flexible dose of Symbicort with conventional stepwise treatment according to asthma treatment guidelines in patients with persistent asthma.

Condition or disease Intervention/treatment Phase
Asthma Drug: Budesonide/formoterol Turbuhaler Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison of Symbicort Single Inhaler and Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents and Adults - a 26-week, Randomised, Open, Parallel Group Multicentre Study
Study Start Date : September 2004
Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: Budesonide/formoterol Turbuhaler
    Other Name: Symbicort

Outcome Measures

Primary Outcome Measures :
  1. Time to first severe asthma exacerbation

Secondary Outcome Measures :
  1. Number of asthma exacerbations, Mean use of as-needed medication, Prescribed asthma medication, Asthma Control Questionnaire, Satisfaction with Asthma Treatment Questionnaire, Safety: Serious Adverse Events and discontinuations due to adverse events

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition. Prescribed inhaled GCS at a dose of ³400 µg/day and within the approved label for the relevant drug during the last 3 months prior to Visit 1.

Exclusion Criteria:

  • Use of any b-blocking agent, including eye-drops, Use of oral GCS as maintenance treatment, A history of smoking ³ 10 pack years (1 pack year = 1 pack (20 cigarettes) per day for one year or equivalent).
Contacts and Locations

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): NCT00259792


  Show 82 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca France Medical Director, MD AstraZeneca
More Information

ClinicalTrials.gov Identifier: NCT00259792     History of Changes
Other Study ID Numbers: D5890L00005
SYMPHONIE
First Posted: December 1, 2005    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011

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
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