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

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca

Criteria

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