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

This study has been completed.
Information provided by:
AstraZeneca 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00782314

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
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Jesenice, Slovenia
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Kamnik-Duplica, Slovenia
Research Site
Kranj, Slovenia
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Litija, Slovenia
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Ljubljana, Slovenia
Research Site
Lucija, Slovenia
Research Site
Maribor, Slovenia
Research Site
Murska Sobota, Slovenia
Research Site
Novo mesto, Slovenia
Research Site
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
Research Site
Topolsica, Slovenia
Research Site
Velenje, Slovenia
Research Site
Vrhnika, Slovenia
Research Site
Zagorje, Slovenia
Sponsors and Collaborators
Principal Investigator: Igor Koren, MD, MSc Radix - medicinske storitve, Igor Koren s.p.
  More Information

No publications provided

Responsible Party: Meta Jeras, Mr Ph, Regulatory and Medical Affairs Manager, AstraZeneca UK Limited, Branch Office in Slovenia 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
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses processed this record on March 02, 2015