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

Tracking Information

First Received Date ^ICMJE

October 29, 2008

Last Updated Date

July 23, 2009

Start Date ^ICMJE

April 2008

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

to determine the efficacy of both possible treatment approaches with Symbicort® Turbuhaler®, measured by asthma control [ Time Frame: three times: 0, 3, 6 months after inclusion ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00782314 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 [ Time Frame: three times: 0, 3, 6 months after inclusion ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Case Control, Prospective

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Study Arms / Comparison Groups

patients with maintenance only treatment with Symbicort Turbuhaler for at least 1 month
patients with SMART treatment with Symbicort Turbuhaler for at least 1 month

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

400

Completion Date

April 2009

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Slovenia

Administrative Information

NCT ID ^ICMJE

NCT00782314

Responsible Party

Meta Jeras, Mr Ph, Regulatory and Medical Affairs Manager, AstraZeneca UK Limited, Branch Office in Slovenia

Study ID Numbers ^ICMJE

NIS-RSI-SYM-2008/1

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Igor Koren, MD, MSc

Radix - medicinske storitve, Igor Koren s.p.

Information Provided By

AstraZeneca

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP