A Comparison of the Control of Asthma Provided by Symbicort® Turbuhaler® Versus Symbicort® Turbuhaler® Plus Pulmicort® Turbuhaler® Plus Terbutaline Turbuhaler® - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00244608

Purpose

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	Intervention	Phase
Asthma	Drug: Budesonide/Formoterol Turbuhaler (Symbicort) Drug: Budesonide Turbuhaler (Pulmicort) Drug: Terbutaline Turbuhaler	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Terbutaline Terbutaline sulfate Formoterol fumarate Budesonide Arformoterol Formoterol Symbicort Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Change in eosinophils in bronchial biopsies (first and last visit) and in sputum (5 times during the 12-month treatment period)

Secondary Outcome Measures:

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

Estimated Enrollment:	100
Study Start Date:	May 2005
Study Completion Date:	March 2007

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00244608

Locations

Denmark
Research Site
Ålborg, Denmark
Research Site
Århus C, Denmark
Research Site
Copenhagen, 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
Barcelona No. 40, Spain
Research Site
Barcelona, No. 42, Spain
Research Site
Baraclado, 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
Leicester, United Kingdom
Research Site
Southampton, United Kingdom
Research Site
London, United Kingdom
Research Site
Manchester, United Kingdom
Research Site
Newcastle-Upon-Tyne, United Kingdom
Research Site
Glasgow, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Symbicort Medical Science Director, MD

AstraZeneca

More Information

No publications provided

Study ID Numbers:	D5890C00003, EudraCT no. 2004-004042-41
Study First Received:	October 25, 2005
Last Updated:	March 10, 2009
ClinicalTrials.gov Identifier:	NCT00244608 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Symbicort
Bronchial Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Hormones
Adrenergic Agonists
Terbutaline
Hypersensitivity
Lung Diseases, Obstructive

Respiratory Tract Diseases
Tocolytic Agents
Therapeutic Uses
Formoterol
Immune System Diseases
Adrenergic beta-Agonists
Sympathomimetics
Budesonide
Asthma
Anti-Asthmatic Agents
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on November 09, 2009