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

Study Overview
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Brief Summary
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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.

Official Title
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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® 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.

Conditions
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Asthma

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Asthma patient with specific treatment | |
| 2<br>Asthma patient on different specific treatment compared to the other group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of rescue medication |  | daily during 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  | 3 times during study | 
| Efficacy variables |  | during 6 month | 
| Safety variables |  | during 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Symbicort SMART, Free Combination GCS/LABA treatment