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A 6 Months NIS to Evaluate the Use of Rescue Medication and Quality of Life in Adult Asthmatic Subjects Treated With Symbicort® SMART®

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00884689
Recruitment Status : Completed
First Posted : April 21, 2009
Last Update Posted : March 31, 2011
ClinResearch, GmbH
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Brief Summary:
The purpose of this study is to describe the use of rescue medication and quality of life in adult asthmatic patients, either treated with SYMBICORT SMART® (regular dose according to physician's prescription and the current summary of product characteristics - SPC) or treated with a free combination of ICS plus LABA plus as needed SABA prescribed by the physician.

Condition or disease

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Official Title: A 6 Months NIS to Evaluate the Use of Rescue Medication and Quality of Life in Adult Asthmatic Subjects Treated With Symbicort® SMART® 1-2 Inhalations b.i.d. as Maintenance Therapy Plus Additional Inhalations As-needed, Compared to Patients Treated With a Free Combination of an Inhaled Glucocorticosteroid and an Inhaled Long Acting ß2-agonist Plus as Needed Inhalations of a Short Acting ß2 Agonist.
Study Start Date : April 2009
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Asthma patient with specific treatment
Asthma patient on different specific treatment compared to the other group

Primary Outcome Measures :
  1. Use of rescue medication [ Time Frame: daily during 6 month ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 3 times during study ]
  2. Efficacy variables [ Time Frame: during 6 month ]
  3. Safety variables [ Time Frame: during 6 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Asthma treatment will not be assigned randomly, but will be administered at the discretion of the physicians according to standard medical practice. Each site should enrol 5 patients using the Symbicort® SMART® principle and 5 patients being prescribed a free combination GCS / LABA treatment.

Inclusion Criteria:

  • Confirmed diagnosis of asthma demonstrating a reversible obstruction during the last 5 years prior to visit 1.
  • Patients being prescribed either Symbicort SMART or a free combination of ICS and LABA with SABA as rescue inhaler and being on that treatment for at least 3 month.
  • A history (documented in the patient's file) of at least one severe asthma exacerbation within 24 months prior to visit 1 but not within the last 30 days prior to Visit 1.
  • A severe asthma exacerbation is defined as a deterioration of asthma leading to at least one of the following:

    • Oral/systemic GCS treatment due to asthma for at least 3 days
    • Unscheduled health-care visit due to asthmaHospitalization or emergency room visit because of asthma requiring treatment with oral/systemic GCS

Exclusion Criteria:

  • Intake of oral, rectal, or parenteral GCS within 30 days prior to visit
  • Use of ß-blocking agents
  • Respiratory infection affecting the asthma, as judged by the investigator, within 30 days prior to visit 1.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00884689

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Research Site
Aschaffenburg, Germany
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Bad Lippspringe, Germany
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Bad Sassendorf, Germany
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Bergkamen, Germany
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Berlin, Germany
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Bochum, Germany
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Bonn, Germany
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Braunschweig, Germany
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Buchholz, Germany
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Chemnitz, Germany
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Coswig, Germany
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Cottbus, Germany
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Dortmund, Germany
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Dresden, Germany
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Dusseldorf, Germany
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Frankfurt, Germany
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Furth, Germany
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Gelsenkirchen, Germany
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Gutersloh, Germany
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Halle, Germany
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Hamburg, Germany
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Ketzin, Germany
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Kothen, Germany
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Leipzig, Germany
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Lohne, Germany
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Lubeck, Germany
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Ludenscheid, Germany
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Marburg, Germany
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Marl, Germany
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Mittelbach, Germany
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Muhlhausen, Germany
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Mulheim, Germany
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Munchen, Germany
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Oschersleben, Germany
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Potsdam, Germany
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Remscheid, Germany
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Saarlouis, Germany
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Schwetzingen, Germany
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Steinhagen, Germany
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Stockach, Germany
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Wedel, Germany
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Wesseling, Germany
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Weyhe, Germany
Sponsors and Collaborators
ClinResearch, GmbH
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Study Director: Kai Richter, MD AstraZeneca

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Responsible Party: Dr. Kai Richter, Vice President Medical Identifier: NCT00884689     History of Changes
Other Study ID Numbers: NIS-RDE-SYM-2009/1
First Posted: April 21, 2009    Key Record Dates
Last Update Posted: March 31, 2011
Last Verified: March 2011
Keywords provided by AstraZeneca:
Symbicort SMART
Free Combination GCS/LABA treatment
Additional relevant MeSH terms:
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Budesonide, Formoterol Fumarate Drug Combination
Anti-Asthmatic Agents
Respiratory System Agents