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

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00884689

Enrollment

500

Registered

2009-04-21

Start date

2009-04-30

Completion date

2010-06-30

Last updated

2011-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Symbicort SMART, Free Combination GCS/LABA treatment

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Use of rescue medication	daily during 6 month

Secondary

Measure	Time frame
Quality of life	3 times during study
Efficacy variables	during 6 month
Safety variables	during 6 month

Countries

Germany

Outcome results