Official Title: “Efficacy and Safety of Symbicort ®Turbuhaler® 160/4.5 µg/Inhalation, Two Inhalations Twice Daily Plus as-Needed Compared With Seretide™ Diskus™ 50/500 µg/Inhalation, One Inhalation Twice Daily Plus Terbutaline Turbuhaler 0.4 Mg/Inhalation as-Needed - a 6-Month, Randomised, Double-Blind, Parallel-Group, Active Controlled, Multinational Phase IIIB Study in Adult and Adolescent Patients With Persistent Asthma (AHEAD).”

The purpose of this study is to compare the efficacy and safety of a variable dose of Symbicort with a high fixed maintenance dose of another asthma medication, Seretide, in the treatment of asthma.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: Budesonide/formoterol Turbuhaler
• Drug: Salmeterol/fluticasone Diskus

Primary Measures

• Time to first severe asthma exacerbation

Secondary Measures

• Number of severe asthma exacerbations
• Mild asthma exacerbations
• FEV1
• Patient-reported outcomes regarding disease status (inlc. PEF), collected via questionnaires and diaries
• Healthcare utilization
• Safety (adverse events)
• - all variables assessed over the 6 months treatment period

Inclusion Criteria:

• Diagnosed with asthma since at least 6 months prior to first visit
• Prescribed daily use of glucocorticosteroids for at least 3 months prior to first visit
• At least one asthma exacerbation more than one but less than twelve months prior to first visit

Exclusion Criteria:

• Respiratory infection affecting asthma within 30 days before first visit
• Use of oral, rectal, or parenteral glucocorticosteroids for within 30 days before first visit
• Any significant disease or disorder that may jeopardize the safety of the patient
• Additional inclusion and exclusion criteria will be evaluated by the Investigator.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

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 September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00242775

Study ID Number: D5890C00002

ClinicalTrials.gov Identifier: NCT00242775

Health Authority: Canada: Health Canada