Evaluating the Symbicort Turbuhaler (Formoterol/Budesonide) Maintenance and Reliever Therapy for Asthma in Daily Practice
1 other identifier
observational
400
1 country
24
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2008
Shorter than P25 for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 29, 2008
CompletedFirst Posted
Study publicly available on registry
October 31, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedJuly 24, 2009
July 1, 2009
October 29, 2008
July 23, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
to determine the efficacy of both possible treatment approaches with Symbicort® Turbuhaler®, measured by asthma control
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
three times: 0, 3, 6 months after inclusion
Study Arms (2)
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 Criteria
patients visiting pulmologist's office
You may qualify if:
- 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
You may not qualify if:
- patients not being treated with Symbicort® Turbuhaler®
- patients treated with Symbicort® Turbuhaler® for COPD
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (24)
Research Site
Celje, Celje, Slovenia
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Dvorec Sela, Dvorec Sela, Slovenia
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Grosuplje, Grosuplje, Slovenia
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Idrija, Idrija, Slovenia
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Izola, Izola, Slovenia
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Jesenice, Jesenice, Slovenia
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Kamnik-Duplica, Kamnik-Duplica, Slovenia
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Kranj, Kranj, Slovenia
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Litija, Litija, Slovenia
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Ljubljana, Ljubljana, Slovenia
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Lucija, Lucija, Slovenia
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Maribor, Maribor City Municipality, Slovenia
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Novo Mesto, Mestna Občina Novo mesto, Slovenia
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Murska Sobota, Murska Sobota, Slovenia
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Domžale, Občina Domžale, Slovenia
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Ravne na Koroškem, Občina Ravne na Koroškem, Slovenia
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Sežana, Občina Sežana, Slovenia
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Ptuja, Ptuja, Slovenia
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Slovenj Gradec, Slovenj Gradec, Slovenia
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Slovenska Bistrica, Slovenska Bistrica, Slovenia
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Topolšica, Topolsica, Slovenia
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Velenje, Velenje, Slovenia
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Vrhnika, Vrhnika, Slovenia
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Zagorje, Zagorje, Slovenia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Igor Koren, MD, MSc
Radix - medicinske storitve, Igor Koren s.p.
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 29, 2008
First Posted
October 31, 2008
Study Start
April 1, 2008
Study Completion
April 1, 2009
Last Updated
July 24, 2009
Record last verified: 2009-07