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NCT00782314 Clinical Trial

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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00782314
Other study ID # NIS-RSI-SYM-2008/1
Secondary ID
Status Completed
Phase N/A
First received October 29, 2008
Last updated July 23, 2009
Start date April 2008
Est. completion date April 2009

Study information
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

Clinical Trial 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.

Recruitment information / eligibility
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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Slovenia, 

Outcome
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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