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CompletedNCT00782314Updated Jul 24, 2009

Evaluating the Symbicort Turbuhaler (Formoterol/Budesonide) Maintenance and Reliever Therapy for Asthma in Daily Practice

An observational study in Asthma, sponsored by AstraZeneca. Completed at 24 sites in Slovenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-07-24.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
400
Ages
18 Years and older
Sex
All
01

Study summary

We want to evaluate efficacy of Symbicort® Turbuhaler® (formoterol/budesonide) therapy for asthma in real life conditions. For this purpose we will include both patients that are treated with Symbicort® Turbuhaler® the "classical" maintenance only treatment approach as well as those treated with the SMART approach.

02

Conditions studied

  • Asthma

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Keywords

  • asthma
  • SMART
  • Symbicort Turbuhaler
  • asthma control
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 400 is above the median of 150 across 970 observational 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 358 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
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients visiting pulmologist's office

Inclusion criteria

  • patients diagnosed with persistent asthma treated with Symbicort® Turbuhaler® in line with its label
  • non-pregnant females
  • existing maintenance only treatment with Symbicort® Turbuhaler® 80 μg/4,5 μg, 160 μg/4,5 μg or 320 μg/9 μg for at least 1 month
  • existing SMART treatment with Symbicort® Turbuhaler® 80 μg/4,5 μg or 160 μg /4,5 μg for at least 1 month

Exclusion criteria

Exclusion Criteria:

  • patients not being treated with Symbicort® Turbuhaler®
  • patients treated with Symbicort® Turbuhaler® for COPD
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
400 participants (estimated)

Groups and cohorts

  • 1

    patients with maintenance only treatment with Symbicort Turbuhaler for at least 1 month

  • 2

    patients with SMART treatment with Symbicort Turbuhaler for at least 1 month

06

What researchers measure

Primary outcomes

  1. to determine the efficacy of both possible treatment approaches with Symbicort® Turbuhaler®, measured by asthma control

    Time frame: three times: 0, 3, 6 months after inclusion

Secondary outcomes

  1. to determine the number of maintenance and reliever inhalations of Symbicort® Turbuhaler®, as well as the concomitant usage of a separate reliever inhaler even in the case of SMART treatment approach

    Time frame: three times: 0, 3, 6 months after inclusion

07

Study locations

24 sites
  • Research Site
    Celje, Slovenia
  • Research Site
    Domzale, Slovenia
  • Research Site
    Dvorec Sela, Slovenia
  • Research Site
    Grosuplje, Slovenia
  • Research Site
    Idrija, Slovenia
  • Research Site
    Izola, Slovenia
  • Research Site
    Jesenice, Slovenia
  • Research Site
    Kamnik-Duplica, Slovenia
  • Research Site
    Kranj, Slovenia
  • Research Site
    Litija, Slovenia
  • Research Site
    Ljubljana, Slovenia
  • Research Site
    Lucija, Slovenia
  • Research Site
    Maribor, Slovenia
  • Research Site
    Murska Sobota, Slovenia
  • Research Site
    Novo mesto, Slovenia
  • Research Site
    Ptuja, Slovenia
  • Research Site
    Ravne na Koroskem, Slovenia
  • Research Site
    Sezana, Slovenia
  • Research Site
    Slovenj Gradec, Slovenia
  • Research Site
    Slovenska Bistrica, Slovenia
  • Research Site
    Topolsica, Slovenia
  • Research Site
    Velenje, Slovenia
  • Research Site
    Vrhnika, Slovenia
  • Research Site
    Zagorje, Slovenia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00782314
Lead sponsor
AstraZeneca
First posted
Oct 31, 2008
Start date
Apr 2008
Completion
Apr 2009
Last update
Jul 24, 2009

Study contacts

Igor Koren, MD, MSc
principal investigator · Radix - medicinske storitve, Igor Koren s.p.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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