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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: October 29, 2008
Last updated: July 23, 2009
Last verified: July 2009
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.


Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluating the Symbicort Turbuhaler (Formoterol/Budesonide) Maintenance and Reliever Therapy for Asthma in Daily Practice

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: April 2008
Study Completion Date: April 2009
patients with maintenance only treatment with Symbicort Turbuhaler for at least 1 month
patients with SMART treatment with Symbicort Turbuhaler for at least 1 month


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • patients not being treated with Symbicort® Turbuhaler®
  • patients treated with Symbicort® Turbuhaler® for COPD
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00782314

Research Site
Celje, Slovenia
Research Site
Domzale, Slovenia
Research Site
Dvorec Sela, Slovenia
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Grosuplje, Slovenia
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Idrija, Slovenia
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Izola, Slovenia
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Jesenice, Slovenia
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Kamnik-Duplica, Slovenia
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Kranj, Slovenia
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Litija, Slovenia
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Ljubljana, Slovenia
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Lucija, Slovenia
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Maribor, Slovenia
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Murska Sobota, Slovenia
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Novo mesto, Slovenia
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Ptuja, Slovenia
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Ravne na Koroskem, Slovenia
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Sezana, Slovenia
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Slovenj Gradec, Slovenia
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Slovenska Bistrica, Slovenia
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Topolsica, Slovenia
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Velenje, Slovenia
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Vrhnika, Slovenia
Research Site
Zagorje, Slovenia
Sponsors and Collaborators
Principal Investigator: Igor Koren, MD, MSc Radix - medicinske storitve, Igor Koren s.p.
  More Information

Responsible Party: Meta Jeras, Mr Ph, Regulatory and Medical Affairs Manager, AstraZeneca UK Limited, Branch Office in Slovenia
ClinicalTrials.gov Identifier: NCT00782314     History of Changes
Other Study ID Numbers: NIS-RSI-SYM-2008/1 
Study First Received: October 29, 2008
Last Updated: July 23, 2009
Health Authority: Slovenia: Agency for Medicinal Products - Ministry of Health

Keywords provided by AstraZeneca:
Symbicort Turbuhaler
asthma control

Additional relevant MeSH terms:
Bronchial Diseases
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Budesonide, Formoterol Fumarate Drug Combination
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 26, 2016