Evaluating the Symbicort Turbuhaler (Formoterol/Budesonide) Maintenance and Reliever Therapy for Asthma in Daily Practice
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00782314
First received: October 29, 2008
Last updated: July 23, 2009
Last verified: July 2009
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00782314
Locations
| Slovenia | |
| Research Site | |
| Celje, Slovenia | |
| Research Site | |
| Domzale, Slovenia | |
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| 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 | |
| Research Site | |
| 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
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 May 23, 2013