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

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

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

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Budesonide/formoterol Turbuhaler vs Conventional Best Asthma Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Phase 3

Contacts and Locations

Study Locations

• Chile
  • Quillota, Chile
    • Research Site
  • Valparaiso, Chile
    • Research Site
• Croatia
  • Dubrovnik, Croatia
    • Researh Site
  • Split, Croatia
    • Research Site
  • Zagreb, Croatia
    • Research Site
• Czech Republic
  • 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
• Greece
  • Ahens, Greece
    • Research Site
  • Alexandroup, Greece
    • Research Site
  • Athens, Greece
    • Research Site
  • Kavala, Greece
    • Research Site
• Iceland
  • Akureyri, Iceland
    • Research Site
  • Reykjavik, Iceland
    • Research Site
• Latvia
  • Daugavpils, Latvia
    • Research Site
  • Riga, Latvia
    • Research Site
  • Rigas raj, Latvia
    • Research Site
• Lithuania
  • Kaunas, Lithuania
    • Research Site
  • Klaipeda, Lithuania
    • Research Site
  • Vilnius, Lithuania
    • Research Site
• Portugal
  • 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
• Slovakia
  • Banská Bystrica, Slovakia
    • Research Site
  • Bardejov, Slovakia
    • Research Site
  • Bratislava, Slovakia
    • Research Site
  • Hlohovec, 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
  • Zilina, Slovakia
    • Research Site
• Slovenia
  • Celje, Slovenia
    • Research Site
  • Golnik, Slovenia
    • Research Site
  • Kamnik, Slovenia
    • Research Site
  • Koper, Slovenia
    • Research Site
  • Litija, Slovenia
    • Research Site
  • Ljubljana, Slovenia
    • Research Site
  • Murska Sobota, Slovenia
    • Research Site
  • Nova Gorica, Slovenia
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to first severe asthma exacerbation

Secondary Outcome Measures

Outcome Measure
Mean use of as-needed medication
Number of asthma exacerbations
Prescribed asthma medication
All variables assessed over the 6 months treatment period
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

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Study Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: November 10, 2005
• First Submitted That Met QC Criteria: November 10, 2005
• First Posted (Estimate): November 15, 2005

Study Record Updates

• Last Update Posted (Estimate): January 24, 2011
• Last Update Submitted That Met QC Criteria: January 21, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Budesonide; Formoterol Fumarate
• Other Study ID Numbers: D5890L00014; STYLE