A Comparison of the Efficacy of Symbicort® Single Inhaler Therapy (Symbicort Turbuhaler® 160/4.5 mg 1 Inhalation b.i.d. Plus As-needed) and Conventional Best Standard Treatment for the Treatment of Persistent Asthma in Adolescents and Adults. A Randomized, Open, Parallel-group, Multicentre 26-weeks Study

AstraZeneca1 site in 1 country1,900 target enrollmentSeptember 2004

ConditionsAsthma

DrugsBudesonide/Formoterol Turbuhaler Conventional Best Asthma Therapy

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Asthma
Sponsor: AstraZeneca
Enrollment: 1900
Locations: 1
Primary Endpoint: Time to first severe asthma exacerbation
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to compare the efficacy of a flexible dose of Symbicort (budesonide/formoterol) with conventional stepwise best standard treatment in patients with persistent asthma.

Registry

clinicaltrials.gov

Start Date

September 2004

End Date

October 2006

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

Inclusion Criteria

•Diagnosis of asthma \>= 3 months
•Prescribed daily use of glucocorticosteroids for at least 3 months prior to Visit 1

Exclusion Criteria

•Smoking history \> 10 pack-years
•Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to inclusion
•Any significant disease or disorder that may jeopardize the safety of the patient.
•Additional inclusion and exclusion criteria will be evaluated by the investigator.