A 6 Months NIS to Evaluate the Use of Rescue Medication and Quality of Life in Adult Asthmatic Subjects Treated With Symbicort® SMART®
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Purpose
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 |
|---|
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Asthma |
| Study Type: | Observational |
| Study Design: | 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. |
- Use of rescue medication [ Time Frame: daily during 6 month ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: 3 times during study ] [ Designated as safety issue: No ]
- Efficacy variables [ Time Frame: during 6 month ] [ Designated as safety issue: No ]
- Safety variables [ Time Frame: during 6 month ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 500 |
| Study Start Date: | April 2009 |
| Study Completion Date: | June 2010 |
| Groups/Cohorts |
|---|
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1
Asthma patient with specific treatment
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2
Asthma patient on different specific treatment compared to the other group
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Contacts and Locations| Germany | |
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| 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 | |
| Study Director: | Kai Richter, MD | AstraZeneca |
More Information
No publications provided
| Responsible Party: | Dr. Kai Richter, Vice President Medical |
| ClinicalTrials.gov Identifier: | NCT00884689 History of Changes |
| Other Study ID Numbers: | NIS-RDE-SYM-2009/1 |
| Study First Received: | April 20, 2009 |
| Last Updated: | March 30, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by AstraZeneca:
|
Symbicort SMART Free Combination GCS/LABA treatment |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate |
Hypersensitivity Immune System Diseases Symbicort Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013