Status:
COMPLETED
Investigation of the Effect of Oral Treatment With 100 mg AZD2423 in Subjects With Mild Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
AstraZeneca
Conditions:
Chronic Obstructive Pulmonary Disease
Lung Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
The purpose of the study is to find out if AZD2423 can reduce inflammation in the lungs of patients with mild COPD.
Eligibility Criteria
Inclusion
- Only women of non-child bearing potential are included in the study i.e. women who are permanently or surgically sterilised or post menopausal.
- ≥ 40 years of age at Visit 1
- Clinical diagnosis of COPD (GOLD stage 1)
- FEV1 ≥ 80% of the predicted normal post-bronchodilator at Visit 1 (GOLD stage 1)
- FEV1/FVC \<70% post-bronchodilator at Visit 1 (GOLD stage 1)
Exclusion
- Any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk or influence the way the drug works
- Any clinically relevant 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 or take part or influence the results of the study
- A past history or current indication of renal (kidney) failure
- Subjects at risk of active tuberculosis or of disease reactivation
- Subjects who have had any clinically significant illness within 4 weeks before Visit 2 (start of treatment)
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT01153321
Start Date
October 1 2010
End Date
July 1 2011
Last Update
April 10 2015
Active Locations (1)
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1
Research Site
Hanover, Hannover, Germany