Status:
COMPLETED
AZD2423 Safety and Tolerability Study in Patients With Moderate and Severe Chronic Obstructive Pulmonary Disease(COPD)
Lead Sponsor:
AstraZeneca
Conditions:
Chronic Obstructive Pulmonary Disease
Lung Disease
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to investigate the tolerability and safety of AZD2423 in Patients with chronic obstructive pulmonary disease.
Eligibility Criteria
Inclusion
- Male or female of non-child bearing potential. Only women of non-child bearing potential are included in the study i.e. women who are permanently or surgically sterilised or post menopausal.
- Between 40 and 80 years of age at Visit 1
- Clinical diagnosis of COPD (GOLD stage 2 or 3)
- FEV1/FVC \<70% and FEV1 between 30 and 80% of the predicted normal post-bronchodilator (GOLD stage 2 or 3)
- Current or ex-smokers
Exclusion
- Any clinically significant disease or disorder (including history of abnormal immune function) which, in the opinion of the Investigator, may either put the subject at risk or influence the way the drug works
- Any lung disease other than COPD, recent respiratory infections which have not resolved fully, active tuberculosis or at risk of reactivation of tuberculosis.
- Any abnormal findings in physical examination, blood or urine test results, vital signs or ECG at Visit 1 that may put the subject at risk during the study, affect their ability to take part or influence the results of the study
- Immunisation with a live vaccine within 3 months or other vaccination within 30 days before planned start of treatment
- Worsening of COPD symptoms within 4 weeks prior to start of study needing hospitalisation, oral steroids or antibiotics.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT01215279
Start Date
October 1 2010
End Date
March 1 2011
Last Update
October 23 2014
Active Locations (6)
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1
Research Site
Rousse, Bulgaria
2
Research Site
Sofia, Bulgaria
3
Research Site
Bratislava, Slovakia
4
Research Site
Košice, Slovakia