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CompletedNCT00252824Updated Jan 24, 2011

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

A Phase 3 interventional study of Budesonide/formoterol Turbuhaler vs Conventional Best Asthma Therapy in Asthma, sponsored by AstraZeneca. Completed at 53 sites in 10 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2011-01-24.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Asthma

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03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,000 participants (estimated)

Interventions

  • DrugBudesonide/formoterol Turbuhaler vs Conventional Best Asthma Therapy

    Also known as: Symbicort

06

What researchers measure

Primary outcomes

  1. Time to first severe asthma exacerbation

Secondary outcomes

  1. Number of asthma exacerbations

  2. Mean use of as-needed medication

  3. Prescribed asthma medication

  4. Asthma Control Questionnaire

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

  6. Safety: Serious Adverse Events and discontinuations due to adverse events

  7. All variables assessed over the 6 months treatment period

07

Study locations

53 sites
  • Research Site
    Quillota, Chile
  • Research Site
    Valparaiso, Chile
  • Researh Site
    Dubrovnik, Croatia
  • Research Site
    Split, Croatia
  • Research Site
    Zagreb, 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
    Akureyri, Iceland
  • Research Site
    Reykjavik, Iceland
  • Research Site
    Daugavpils, Latvia
  • Research Site
    Rigas raj, Latvia
  • Research Site
    Riga, 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
    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
    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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00252824
Lead sponsor
AstraZeneca
First posted
Nov 15, 2005
Start date
Jul 2005
Completion
Dec 2006
Last update
Jan 24, 2011

Study contacts

AstraZeneca Symbicort Medical Science Director, MD
study director · AstraZeneca
View the source record on ClinicalTrials.gov ↗

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