Clinical trial NCT00782314: Evaluating the Symbicort Turbuhaler (Formoterol/Budesonide) Maintenance and Reliever Therapy for Asthma in Daily Practice
Official title: Evaluating the Symbicort Turbuhaler (Formoterol/Budesonide) Maintenance and Reliever Therapy for Asthma in Daily Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: asthma
SMART
Symbicort Turbuhaler
asthma control
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-10-31
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients visiting pulmologist's office

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.


Eligibility 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

Primary outcomes:
measure: to determine the efficacy of both possible treatment approaches with Symbicort® Turbuhaler®, measured by asthma control
timeFrame: three times: 0, 3, 6 months after inclusion
Secondary outcomes:
measure: 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
timeFrame: three times: 0, 3, 6 months after inclusion
Other outcomes:
Locations:
city: Celje
country: Slovenia
facility: Research Site
city: Domzale
country: Slovenia
facility: Research Site
city: Dvorec Sela
country: Slovenia
facility: Research Site
city: Grosuplje
country: Slovenia
facility: Research Site
city: Idrija
country: Slovenia
facility: Research Site
city: Izola
country: Slovenia
facility: Research Site
city: Jesenice
country: Slovenia
facility: Research Site
city: Kamnik-Duplica
country: Slovenia
facility: Research Site
city: Kranj
country: Slovenia
facility: Research Site
city: Litija
country: Slovenia
facility: Research Site
city: Ljubljana
country: Slovenia
facility: Research Site
city: Lucija
country: Slovenia
facility: Research Site
city: Maribor
country: Slovenia
facility: Research Site
city: Murska Sobota
country: Slovenia
facility: Research Site
city: Novo mesto
country: Slovenia
facility: Research Site
city: Ptuja
country: Slovenia
facility: Research Site
city: Ravne na Koroskem
country: Slovenia
facility: Research Site
city: Sezana
country: Slovenia
facility: Research Site
city: Slovenj Gradec
country: Slovenia
facility: Research Site
city: Slovenska Bistrica
country: Slovenia
facility: Research Site
city: Topolsica
country: Slovenia
facility: Research Site
city: Velenje
country: Slovenia
facility: Research Site
city: Vrhnika
country: Slovenia
facility: Research Site
city: Zagorje
country: Slovenia
facility: Research Site
Study officials:
affiliation: Radix - medicinske storitve, Igor Koren s.p.
name: Igor Koren, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: