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A Comparison of the Control of Asthma Provided by Symbicort® Turbuhaler® Versus Symbicort® Turbuhaler® Plus Pulmicort® Turbuhaler® Plus Terbutaline Turbuhaler®

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ClinicalTrials.gov Identifier: NCT00244608
Recruitment Status : Completed
First Posted : October 27, 2005
Last Update Posted : January 24, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to determine if a flexible dose of Symbicort has a similar effect on the airways of patients with asthma as a higher fixed-dose of Symbicort with additional glucocorticosteroids added.

Condition or disease Intervention/treatment Phase
Asthma Drug: Budesonide/Formoterol Turbuhaler Drug: Budesonide Turbuhaler (Pulmicort) Drug: Terbutaline Turbuhaler Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Comparison of the Inflammatory Control of Asthma Provided by One Inhalation of Symbicort® Turbuhaler® 160/4.5 µg/Inhalation b.i.d. Plus As-needed Versus One Inhalation of Symbicort® Turbuhaler® 320/9 µg/Inhalation b.i.d. + One Inhalation of Pulmicort® Turbuhaler® 400 µg/Dose b.i.d. Plus Terbutaline Turbuhaler® 0.4 mg/Inhalation As-needed. A 12-month, Randomised, Double-blind, Parallel-group, Active Controlled, Multinational, Phase IIIB Study in Adult Patients With Asthma, EOS
Study Start Date : May 2005
Study Completion Date : March 2007

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
    Drug: Budesonide Turbuhaler (Pulmicort) Drug: Terbutaline Turbuhaler

Outcome Measures

Primary Outcome Measures :
  1. Change in eosinophils in bronchial biopsies (first and last visit) and in sputum (5 times during the 12-month treatment period)

Secondary Outcome Measures :
  1. Immunopathology and remodeling in biopsies
  2. Immunopathology and mediators in induced sputum
  3. Severe asthma exacerbations (number of and time to first)
  4. Forced expiratory volume in 1 second (FEV1)
  5. As-needed use
  6. Safety variables, including adverse events and vital signs
  7. All variables assessed over the 12-month treatment period

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of asthma for at least 6 months
  • Prescribed daily use of glucocorticosteroids for at least 3 months prior to visit one

Exclusion Criteria:

  • Respiratory infection affecting asthma within 30 days prior to study
  • Intake of oral, rectal, or parenteral glucocorticosteroids within 30 days prior to study
  • Any significant disease or disorder that may jeopardize the safety of the patient
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): NCT00244608


Locations
Denmark
Research Site
Copenhagen, Denmark
Research Site
Ålborg, Denmark
Research Site
Århus C, Denmark
France
Research Site
Montpellier, France
Research Site
Pessac, France
Germany
Research Site
Hannover, Germany
Research Site
Mainz, Germany
Research Site
Marburg, Germany
Spain
Research Site
Baraclado, Spain
Research Site
Barcelona No. 40, Spain
Research Site
Barcelona, No. 42, Spain
Sweden
Research Site
Göteborg, Sweden
Research Site
Lund, Sweden
Research Site
Stockholm, Sweden
Research Site
Umeå, Sweden
Research Site
Uppsala, Sweden
United Kingdom
Research Site
Glasgow, United Kingdom
Research Site
Leicester, United Kingdom
Research Site
London, United Kingdom
Research Site
Manchester, United Kingdom
Research Site
Newcastle-Upon-Tyne, United Kingdom
Research Site
Southampton, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Symbicort Medical Science Director, MD AstraZeneca
More Information

ClinicalTrials.gov Identifier: NCT00244608     History of Changes
Other Study ID Numbers: D5890C00003
EudraCT no. 2004-004042-41
First Posted: October 27, 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
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