Evaluation of Symbicort® Turbuhaler® (Budesonide/Formoterol) in Chronic Obstructive Pulmonary Disease (COPD)

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT00837629
• Lead Sponsor: AstraZeneca

Brief Summary

This non-interventional study is to analyse the therapeutic effectiveness in patients with severe COPD following a generally accepted 12-week treatment period with Symbicort Turbuhaler, which could anyhow be shortened or extended at physician's discretion.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Study First Submitted: 2009-02-04
• Study First Submitted QC: 2009-02-04
• Study First Posted: 2009-02-05
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-21
• Last Update Posted: 2011-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 743

Inclusion Criteria

• non pregnant female
• COPD with persistent symptoms in spite of regular bronchodilator therapy
• Naive or fixed combination treated patients including patients already on Symbicort Turbuhaler

Exclusion Criteria

• Hypersensitivity to budesonide, formoterol or inhaled lactose

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in overall Clinical COPD Questionnaire (CCQ) score	12 weeks

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	12 weeks
Physicians' global clinical impression of the treatment	12 weeks
Evaluation of smoking habits	12 weeks