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

July 23, 2009 updated by: AstraZeneca
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • 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, Slovenia
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients visiting pulmologist's office

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
patients with maintenance only treatment with Symbicort Turbuhaler for at least 1 month
2
patients with SMART treatment with Symbicort Turbuhaler for at least 1 month

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
three times: 0, 3, 6 months after inclusion

Secondary Outcome Measures

Outcome 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
Time Frame: three times: 0, 3, 6 months after inclusion
three times: 0, 3, 6 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Igor Koren, MD, MSc, Radix - medicinske storitve, Igor Koren s.p.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

October 29, 2008

First Submitted That Met QC Criteria

October 29, 2008

First Posted (Estimate)

October 31, 2008

Study Record Updates

Last Update Posted (Estimate)

July 24, 2009

Last Update Submitted That Met QC Criteria

July 23, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-RSI-SYM-2008/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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