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

Condition(s) targeted: Asthma

Phase: N/A

Status: Recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Kai Richter, MD, Study Director, Affiliation: AstraZeneca

Overall contact:
AstraZeneca Germany Clinical Study Information, Phone: +49 800 228 8660

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: 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 design: Case-Only, Other

Primary outcome: Use of rescue medication

Secondary outcome:

Quality of life

Efficacy variables

Safety variables

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

AstraZeneca Germany Clinical Study Information, Phone: +49 800 228 8660

Research Site, Aschaffenburg, Germany; Recruiting

Research Site, Bad Lippspringe, Germany; Recruiting

Research Site, Bad Sassendorf, Germany; Recruiting

Research Site, Bergkamen, Germany; Recruiting

Research Site, Berlin, Germany; Recruiting

Research Site, Bochum, Germany; Recruiting

Research Site, Bonn, Germany; Recruiting

Research Site, Braunschweig, Germany; Recruiting

Research Site, Buchholz, Germany; Recruiting

Research Site, Chemnitz, Germany; Recruiting

Research Site, Coswig, Germany; Recruiting

Research Site, Cottbus, Germany; Recruiting

Research Site, Dortmund, Germany; Recruiting

Research Site, Dresden, Germany; Recruiting

Research Site, Dusseldorf, Germany; Recruiting

Research Site, Frankfurt, Germany; Recruiting

Research Site, Furth, Germany; Recruiting

Research Site, Gelsenkirchen, Germany; Recruiting

Research Site, Gutersloh, Germany; Recruiting

Research Site, Halle, Germany; Recruiting

Research Site, Hamburg, Germany; Recruiting

Research Site, Ketzin, Germany; Recruiting

Research Site, Kothen, Germany; Recruiting

Research Site, Leipzig, Germany; Recruiting

Research Site, Lohne, Germany; Recruiting

Research Site, Lubeck, Germany; Recruiting

Research Site, Ludenscheid, Germany; Recruiting

Research Site, Marburg, Germany; Recruiting

Research Site, Marl, Germany; Recruiting

Research Site, Mittelbach, Germany; Recruiting

Research Site, Muhlhausen, Germany; Recruiting

Research Site, Mulheim, Germany; Recruiting

Research Site, Munchen, Germany; Recruiting

Research Site, Oschersleben, Germany; Recruiting

Research Site, Potsdam, Germany; Recruiting

Research Site, Remscheid, Germany; Recruiting

Research Site, Saarlouis, Germany; Recruiting

Research Site, Schwetzingen, Germany; Recruiting

Research Site, Steinhagen, Germany; Recruiting

Research Site, Stockach, Germany; Recruiting

Research Site, Wedel, Germany; Recruiting

Research Site, Wesseling, Germany; Recruiting

Research Site, Weyhe, Germany; Recruiting

Starting date: April 2009
Ending date: April 2010
Last updated: October 13, 2009