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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00782314
First received: October 29, 2008
Last updated: July 23, 2009
Last verified: July 2009
  Purpose

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.


Condition
Asthma

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
Groups/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

  Eligibility

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

Criteria

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

Locations
Slovenia
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
Sponsors and Collaborators
AstraZeneca
Investigators
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
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:
asthma
SMART
Symbicort Turbuhaler
asthma control

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Formoterol
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014