A follow-up programme for patients using Symbicort® Turbuhaler®maintenance and reliever therapy in normal clinical practice - SATUR

• Conditions: Asthma; MedDRA version: 8.1Level: LLTClassification code 10003553Term: Asthma

• Registration Number: EUCTR2006-005677-22-BG
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 8000

Inclusion Criteria

For inclusion in the follow-up programme patients must fulfil all of the following criteria:
1. Asthma patients prescribed Symbicort as maintenance and reliever therapy,
according to the label, before inclusion in this programme.
2. Signed and dated informed consent (ICF). For patients under-age, signed and dated ICF form from both the patient and the patient’s parent/legal guardian is required.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Since this programme intends to describe Symbicort use in routine clinical practice when prescribed as Symbicort maintenance and reliever therapy, there are no programme specific exclusion criteria, other than:
1. Involvement in the planning and conduct of the study (applies to both AstraZeneca
staff or staff at the investigational site).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this follow-up programme is to investigate the extent of Symbicort use in patients prescribed Symbicort as maintenance and reliever therapy.;Secondary Objective: ;Primary end point(s): The primary variable is the total daily use of Symbicort.