Status:
COMPLETED
A 4 Week Study to Investigate the Safety and Tolerability of AZD5069 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
AstraZeneca
Conditions:
Scientific Terminology Chronic Obstructive Pulmonary Disease (COPD)
Laymen Terminology Chronic Bronchitis and Emphysema
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is the evaluate the safety and tolerability of AZD5069 in patients with Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT01233232
Start Date
November 1 2010
End Date
March 1 2011
Last Update
September 17 2015
Active Locations (8)
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1
Research Site
Sofia, Bulgaria
2
Research Site
Berlin, Germany
3
Research Site
Großhansdorf, Germany
4
Research Site
Debrecen, Hungary