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

Condition(s) targeted: Asthma

Intervention: Budesonide/formoterol Turbuhaler vs Conventional Best Asthma Therapy (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Symbicort Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

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

Official title: 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 Practice for the Treatment of Persistent Asthma in Adolescents and Adults - a 26 Weeks, Randomised, Open-Label, Parallel-Group, Multicentre Study

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Time to first severe asthma exacerbation

Secondary outcome:

Number of asthma exacerbations

Mean use of as-needed medication

Prescribed asthma medication

Asthma Control Questionnaire

Asthma related costs (direct asthma medication, direct non-medication costs and indirect costs)

Safety: Serious Adverse Events and discontinuations due to adverse events

All variables assessed over the 6 months treatment period

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Research Site, QUILLOTA, Chile

Research Site, VALPARAISO, Chile

Research Site, Zagreb, Croatia

Research Site, Split, Croatia

Researh Site, Dubrovnik, Croatia

Research Site, BRNO, Czech Republic

Research Site, HRADEC KRÁLOVÉ, Czech Republic

Research Site, JIHLAVA, Czech Republic

Research Site, LITOMICE, Czech Republic

Research Site, OSTRAVA, Czech Republic

Research Site, PRAHA, Czech Republic

Research Site, PROSTIJOV, Czech Republic

Research Site, STRAKONICE, Czech Republic

Research Site, AHENS, Greece

Research Site, ALEXANDROUP, Greece

Research Site, ATHENS, Greece

Research Site, KAVALA, Greece

Research Site, Reykjavik, Iceland

Research Site, Akureyri, Iceland

Research Site, Daugavpils, Latvia

Research Site, Riga, Latvia

Research Site, Rigas raj, Latvia

Research Site, Kaunas, Lithuania

Research Site, Klaipeda, Lithuania

Research Site, Vilnius, Lithuania

Research Site, Aveiro, Portugal

Research Site, Coimbra, Portugal

Research Site, Coviha, Portugal

Research Site, Lisboa, Portugal

Research Site, Porto, Portugal

Research Site, Setubal, Portugal

Research Site, Vila Nova de Gaia, Portugal

Research Site, BANSKÁ BYSTRICA, Slovakia

Research Site, BARDEJOV, Slovakia

Research Site, BRATISLAVA, Slovakia

Research Site, HLOHOVEC, Slovakia

Research Site, ZILINA, Slovakia

Research Site, KOSICE, Slovakia

Research Site, LIPTOVSKÝ HRÁDOK, Slovakia

Research Site, MALACKY, Slovakia

Research Site, NITRA ZOBOR, Slovakia

Research Site, PARTIZÁNSKE, Slovakia

Research Site, REVÚCA, Slovakia

Research Site, SENEC, Slovakia

Research Site, TOPOSTANY, Slovakia

Research Site, Golnik, Slovenia

Research Site, Murska Sobota, Slovenia

Research Site, Celje, Slovenia

Research Site, Kamnik, Slovenia

Research Site, Litija, Slovenia

Research Site, Ljubljana, Slovenia

Research Site, Nova Gorica, Slovenia

Research Site, KOPER, Slovenia

Starting date: July 2005
Last updated: January 11, 2008