Evaluate Onset of Effect in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Formoterol Turbuhaler®

A Randomised, Placebo-controlled, Double-blind (Double-dummy Technique),Crossover, Multi-centre Study, to Evaluate Onset of Effect in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Formoterol Turbuhaler® 9 μg, Compared With Serevent® Diskus® 50 μg.

• Primary objective is to evaluate time to onset of effect of formoterol, 9 μg single dose,compared with salmeterol, 50 μg single dose, in patients with moderate COPD.Forced Expiratory Volume in 1 second (FEV1) measured by spirometry 5 minutes postdose.
• Secondary efficacy variables: Average FEV1 during the first 15 minutes (area under the FEV1 curve from 0 to 15 minutes), Average FEV1 during 120 minutes (area under the FEV1 curve from 0 to 120 minutes)

Inclusion Criteria:

• A clinical diagnosis of COPD according to GOLD guidelines, and current COPD symptoms
• A current or previous smoking history equivalent to 10 or more packs per year (1 pack year = 20 cigarettes smoked per day for one year).
• Documented use of a short-acting inhaled bronchodilator (β2-agonist or anticholinergics) as reliever medication.

Exclusion Criteria:

• A history and/or current diagnosis of asthma.
• Patients who have experienced COPD exacerbation requiring hospitalisation and/or a course of antibiotics and/or a course of systemic steroid within 30 days (from end of exacerbation treatment) prior to Visit 1 and/or during the run-in period.
• A history and/or current diagnosis of atopic diseases such as allergic rhinitis or eczema before the age of 40.