Asthma Clinical Trial
Official title:
Evaluating the Symbicort Turbuhaler (Formoterol/Budesonide) Maintenance and Reliever Therapy for Asthma in Daily Practice
Verified date | July 2009 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | Slovenia: Agency for Medicinal Products - Ministry of Health |
Study type | Observational |
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.
Status | Completed |
Enrollment | 400 |
Est. completion date | April 2009 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
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 |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Slovenia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | to determine the efficacy of both possible treatment approaches with Symbicort® Turbuhaler®, measured by asthma control | three times: 0, 3, 6 months after inclusion | No | |
Secondary | 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 | No |
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