A 4 Week Study to Investigate the Safety and Tolerability of AZD5069 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

A 4 Week, Double Blind, Placebo Controlled, Randomised, Parallel Group, Multicentre, Phase IIa Study to Investigate the Safety and Tolerability of AZD5069 as Oral Capsules in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

The purpose of this study is the evaluate the safety and tolerability of AZD5069 in patients with Chronic Obstructive Pulmonary Disease

Inclusion Criteria:

• Clinical diagnosis of COPD with symptoms for more than one year before screening
• Body mass index of 18-30 kg/m2 and weight of 50-100kg
• Current or ex-smokers with a smoking history of at least 10 pack years (1 pack year = tobacco consumption corresponding to 20 cigarettes smoked per day for one year) at screening
• FEV1 of 30% or above and less than 80% of the predicted normal value post-bronchodilator at screening
• FEV1/FVC less than 70% post-bronchodilator at screening

Exclusion Criteria:

• Any clinically significant disease or disorder
• Exacerbation of COPD which was not resolved within 30 days of first dosing
• Patients who have received live or live-attenuated vaccine in the 2 weeks prior to first dosing
• Asthma and any current respiratory tract disorder other than COPD which is considered to be clinically significant
• Disease history suggesting reduced or abnormal immune function other than that related to COPD