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

AstraZeneca

Status: Completed

Conditions: Asthma

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00884689

NIS-RDE-SYM-2009/1

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

500 participants in 2 patient groups

1

Description:

Asthma patient with specific treatment

2

Description:

Asthma patient on different specific treatment compared to the other group