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).

AstraZeneca1 site in 1 country2,100 target enrollmentMay 2005

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 2005

End Date

May 2006

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Time to first severe asthma exacerbation

Secondary Outcomes

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