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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00782314

Enrollment

400

Registered

2008-10-31

Start date

2008-04-30

Completion date

2009-04-30

Last updated

2009-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

asthma, SMART, Symbicort Turbuhaler, asthma control

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Slovenia

Outcome results