Asthma Clinical Trial
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.
| Verified date | March 2011 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Federal Institute for Drugs and Medical Devices |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 500 |
| Est. completion date | June 2010 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Observational Model: Case-Only
| Country | Name | City | State |
|---|---|---|---|
| Germany | Research Site | Aschaffenburg | |
| Germany | Research Site | Bad Lippspringe | |
| Germany | Research Site | Bad Sassendorf | |
| Germany | Research Site | Bergkamen | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Bochum | |
| Germany | Research Site | Bonn | |
| Germany | Research Site | Braunschweig | |
| Germany | Research Site | Buchholz | |
| Germany | Research Site | Chemnitz | |
| Germany | Research Site | Coswig | |
| Germany | Research Site | Cottbus | |
| Germany | Research Site | Dortmund | |
| Germany | Research Site | Dresden | |
| Germany | Research Site | Dusseldorf | |
| Germany | Research Site | Frankfurt | |
| Germany | Research Site | Furth | |
| Germany | Research Site | Gelsenkirchen | |
| Germany | Research Site | Gutersloh | |
| Germany | Research Site | Halle | |
| Germany | Research Site | Hamburg | |
| Germany | Research Site | Ketzin | |
| Germany | Research Site | Kothen | |
| Germany | Research Site | Leipzig | |
| Germany | Research Site | Lohne | |
| Germany | Research Site | Lubeck | |
| Germany | Research Site | Ludenscheid | |
| Germany | Research Site | Marburg | |
| Germany | Research Site | Marl | |
| Germany | Research Site | Mittelbach | |
| Germany | Research Site | Muhlhausen | |
| Germany | Research Site | Mulheim | |
| Germany | Research Site | Munchen | |
| Germany | Research Site | Oschersleben | |
| Germany | Research Site | Potsdam | |
| Germany | Research Site | Remscheid | |
| Germany | Research Site | Saarlouis | |
| Germany | Research Site | Schwetzingen | |
| Germany | Research Site | Steinhagen | |
| Germany | Research Site | Stockach | |
| Germany | Research Site | Wedel | |
| Germany | Research Site | Wesseling | |
| Germany | Research Site | Weyhe |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca | ClinResearch, GmbH |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Use of rescue medication | daily during 6 month | No | |
| Secondary | Quality of life | 3 times during study | No | |
| Secondary | Efficacy variables | during 6 month | No | |
| Secondary | Safety variables | during 6 month | Yes |
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