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STYLE - Symbicort Single Inhaler Therapy vs Conventional Therapy in Treatment of Persistent Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00252824
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : January 24, 2011
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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 vs Conventional Best Asthma Therapy Phase 3

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 the Efficacy of Symbicort® Single Inhaler Therapy (Symbicort Turbuhaler® 160/4.5 mg 1 Inhalation b.i.d. Plus As-needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents and Adults - a 26 Weeks, Randomised, Open-label, Parallel-group, Multicentre Study
Study Start Date : July 2005
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Intervention Details:
    Drug: Budesonide/formoterol Turbuhaler vs Conventional Best Asthma Therapy
    Other Name: Symbicort

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

Secondary Outcome Measures :
  1. Number of asthma exacerbations
  2. Mean use of as-needed medication
  3. Prescribed asthma medication
  4. Asthma Control Questionnaire
  5. Asthma related costs (direct asthma medication, direct non-medication costs and indirect costs)
  6. Safety: Serious Adverse Events and discontinuations due to adverse events
  7. All variables assessed over the 6 months treatment period

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

Inclusion Criteria:

  • - Diagnosis of asthma ³ 3 months
  • Prescribed daily use of glucocorticosteroids at a dose > 320 mcg/ day for at least 3 months prior to Visit 1

Exclusion Criteria:

  • Smoking history > 10 pack-years
  • Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to inclusion
  • Any significant disease or disorder that my jeopardize the safety of the patient.

Additional inclusion and exclusion criteria will be evaluated by the investigator.

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 identifier (NCT number): NCT00252824

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Sponsors and Collaborators
Study Director: AstraZeneca Symbicort Medical Science Director, MD AstraZeneca

Additional Information: Identifier: NCT00252824     History of Changes
Other Study ID Numbers: D5890L00014
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Formoterol Fumarate
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
Hormones, Hormone Substitutes, and Hormone Antagonists