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

Completed

• Conditions: Asthma

• Registration Number: NCT00884689
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-20
• Study First Submitted QC: 2009-04-20
• Study First Posted: 2009-04-21
• Study Completion: 2010-06
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-30
• Last Update Posted: 2011-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Use of rescue medication	daily during 6 month

Secondary Outcome Measures

Name	Time	Method
Quality of life	3 times during study
Efficacy variables	during 6 month
Safety variables	during 6 month

Trial Locations

Locations (1)

Research Site; 🇩🇪 Weyhe, Germany