Evaluation of Efficacy on Exercise Tolerance of Symbicort (Budesonide/Formoterol) Compared to Placebo and Oxis in Patients With Severe COPD

A Multi-centre, Randomised, Double-blind, Cross-over Design Study to Evaluate Efficacy on Exercise Tolerance of Symbicort ®(Budesonide/Formoterol) 320/9μg One Inhalation Twice Daily Compared With Placebo and Oxis® 9μg One Inhalation Twice Daily in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD).

The purpose of this study is to investigate the effect on exercise tolerance, lung function and symptoms after treatment with Symbicort, Oxis or placebo in patients with severe chronic obstructive pulmonary disease.

Inclusion Criteria:

• >=40 years of age
• diagnosed COPD with symptoms >= 2 years
• pre-bronchodilatory FEV1 <=50% of PN

Exclusion Criteria:

• Current respiratory tract disorder other than COPD
• history of asthma or rhinitis
• significant or unstable cardiovascular disorder