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

NCT00252824 | Completed Phase 3

• 2 other identifiers: D5890L00014STYLE
• Study Type: interventional
• Target: 1,000
• Locations: 9 countries
• Sites: 40

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

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Time to first severe asthma exacerbation

Secondary Outcomes (7)

• 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)

Interventions

Budesonide/formoterol Turbuhaler vs Conventional Best Asthma Therapy DRUG

Also known as: Symbicort

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• Smoking history \> 10 pack-years
• Any significant disease or disorder that my jeopardize the safety of the patient.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (53)

Research Site

Quillota, Chile

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Valparaíso, Chile

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Dubrovnik, Croatia

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Split, Croatia

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Zagreb, Croatia

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Brno, Czechia

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Hradec Králové, Czechia

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Jihlava, Czechia

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Litomice, Czechia

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Ostrava, Czechia

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Prague, Czechia

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Prostijov, Czechia

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Strakonice, Czechia

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Ahens, Greece

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Alexandroup, Greece

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Athens, Greece

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Kavala, Greece

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Akureyri, Iceland

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Reykjavik, Iceland

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Daugavpils, Latvia

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Riga, Latvia

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Rigas Raj, Latvia

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Kaunas, Lithuania

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Klaipėda, Lithuania

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Vilnius, Lithuania

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Aveiro, Portugal

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Coimbra, Portugal

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Coviha, Portugal

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Lisbon, Portugal

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Porto, Portugal

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Setúbal, Portugal

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Vila Nova de Gaia, Portugal

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Banská Bystrica, Slovakia

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Bardejov, Slovakia

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Bratislava, Slovakia

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Hlohovec, Slovakia

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Košice, Slovakia

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Liptovský Hrádok, Slovakia

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Malacky, Slovakia

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Nitra Zobor, Slovakia

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Partizánske, Slovakia

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Revúca, Slovakia

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Senec, Slovakia

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Topostany, Slovakia

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Žilina, Slovakia

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Celje, Slovenia

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Golnik, Slovenia

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Kamnik, Slovenia

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Koper, Slovenia

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Litija, Slovenia

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Ljubljana, Slovenia

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Murska Sobota, Slovenia

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Nova Gorica, Slovenia

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MeSH Terms

Conditions

Asthma

Interventions

Budesonide; Budesonide, Formoterol Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Formoterol Fumarate; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Drug Combinations; Pharmaceutical Preparations

Study Officials

• AstraZeneca Symbicort Medical Science Director, MD

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 10, 2005
• First Posted: November 15, 2005
• Study Start: July 1, 2005
• Study Completion: December 1, 2006
• Last Updated: January 24, 2011

Record last verified: 2011-01

Locations

PT (7); CL (2); IC (2); SL (8); LI (3); LA (3); CZ (8); CR (3); GR (4)