STYLE - Symbicort Single Inhaler Therapy vs Conventional Therapy in Treatment of Persistent Asthma

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Budesonide/formoterol Turbuhaler vs Conventional Best Asthma Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00252824

D5890L00014

STYLE

Details and patient eligibility

About

The purpose of the study is to compare the efficacy of a flexible dose of Symbicort with conventional stepwise treatment according to asthma treatment guidelines in patients with persistent asthma

Enrollment: 1,000 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • Diagnosis of asthma ³ 3 months
• Prescribed daily use of glucocorticosteroids at a dose > 320 mcg/ day 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 my jeopardize the safety of the patient.

Additional inclusion and exclusion criteria will be evaluated by the investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)