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”

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.

Study Type: Interventional

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

Study Primary Completion Date: March 2007

Intervention(s) in this Clinical Trial

• Drug: Budesonide/Formoterol Turbuhaler (Symbicort)
• Drug: Budesonide Turbuhaler (Pulmicort)
• Drug: Terbutaline Turbuhaler

Primary Measures

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

Secondary 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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

AstraZeneca Symbicort Medical Science Director, MD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00244608

Study ID Number: D5890C00003

ClinicalTrials.gov Identifier: NCT00244608

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency