Clinical trial NCT00252824: STYLE - Symbicort Single Inhaler Therapy vs Conventional Therapy in Treatment of 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-15
Enrollment: 1000
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility 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.

Primary outcomes:
measure: Time to first severe asthma exacerbation
Secondary outcomes:
measure: Number of asthma exacerbations
measure: Mean use of as-needed medication
measure: Prescribed asthma medication
measure: Asthma Control Questionnaire
measure: Asthma related costs (direct asthma medication, direct non-medication costs and indirect costs)
measure: Safety: Serious Adverse Events and discontinuations due to adverse events
measure: All variables assessed over the 6 months treatment period
Other outcomes:
Locations:
city: Quillota
country: Chile
facility: Research Site
city: Valparaiso
country: Chile
facility: Research Site
city: Dubrovnik
country: Croatia
facility: Researh Site
city: Split
country: Croatia
facility: Research Site
city: Zagreb
country: Croatia
facility: Research Site
city: Brno
country: Czech Republic
facility: Research Site
city: Hradec Králové
country: Czech Republic
facility: Research Site
city: Jihlava
country: Czech Republic
facility: Research Site
city: Litomice
country: Czech Republic
facility: Research Site
city: Ostrava
country: Czech Republic
facility: Research Site
city: Praha
country: Czech Republic
facility: Research Site
city: Prostijov
country: Czech Republic
facility: Research Site
city: Strakonice
country: Czech Republic
facility: Research Site
city: Ahens
country: Greece
facility: Research Site
city: Alexandroup
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Kavala
country: Greece
facility: Research Site
city: Akureyri
country: Iceland
facility: Research Site
city: Reykjavik
country: Iceland
facility: Research Site
city: Daugavpils
country: Latvia
facility: Research Site
city: Rigas raj
country: Latvia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Kaunas
country: Lithuania
facility: Research Site
city: Klaipeda
country: Lithuania
facility: Research Site
city: Vilnius
country: Lithuania
facility: Research Site
city: Aveiro
country: Portugal
facility: Research Site
city: Coimbra
country: Portugal
facility: Research Site
city: Coviha
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: Setubal
country: Portugal
facility: Research Site
city: Vila Nova de Gaia
country: Portugal
facility: Research Site
city: Banská Bystrica
country: Slovakia
facility: Research Site
city: Bardejov
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Hlohovec
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Liptovský Hrádok
country: Slovakia
facility: Research Site
city: Malacky
country: Slovakia
facility: Research Site
city: Nitra Zobor
country: Slovakia
facility: Research Site
city: Partizánske
country: Slovakia
facility: Research Site
city: Revúca
country: Slovakia
facility: Research Site
city: Senec
country: Slovakia
facility: Research Site
city: Topostany
country: Slovakia
facility: Research Site
city: Zilina
country: Slovakia
facility: Research Site
city: Celje
country: Slovenia
facility: Research Site
city: Golnik
country: Slovenia
facility: Research Site
city: Kamnik
country: Slovenia
facility: Research Site
city: Koper
country: Slovenia
facility: Research Site
city: Litija
country: Slovenia
facility: Research Site
city: Ljubljana
country: Slovenia
facility: Research Site
city: Murska Sobota
country: Slovenia
facility: Research Site
city: Nova Gorica
country: Slovenia
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Symbicort Medical Science Director, MD
role: STUDY_DIRECTOR
References: