AZD2423 Safety and Tolerability Study in Patients With Moderate and Severe Chronic Obstructive Pulmonary Disease(COPD)

AstraZeneca

Status and phase

Completed

Phase 2

Conditions

Chronic Obstructive Pulmonary Disease

Lung Disease

Treatments

Drug: AZD2423

Drug: Placebo to AZD2423

Study type

Interventional

Funder types

Industry

Identifiers

D3320C00002

Details and patient eligibility

About

The purpose of the study is to investigate the tolerability and safety of AZD2423 in Patients with chronic obstructive pulmonary disease.

Enrollment

63 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.