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

An Open-label Non-interventional Evaluation of Efficacy of Symbicort® Forte Turbuhaler 320/9 µg (Budesonide / Formoterol) and Symbicort® Turbuhaler® 160/4,5 µg (Budesonide / Formoterol)in Functional Status Improvement of Patients With Chronic Obstructive Pulmonary Disease (COPD)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00837629

Enrollment

743

Registered

2009-02-05

Start date

2007-02-28

Completion date

2007-09-30

Last updated

2011-01-24

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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

chronic obstructive pulmonary disease, COPD, Symbicort Turbuhaler

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Reduction in overall Clinical COPD Questionnaire (CCQ) score	12 weeks

Secondary

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

Outcome results