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Investigation of the Effect of Oral Treatment With 100 mg AZD2423 in Subjects With Mild Chronic Obstructive Pulmonary Disease (COPD)

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 2

Conditions

Chronic Obstructive Pulmonary Disease
Lung Disease

Treatments

Drug: AZD2423
Drug: AZD2423 Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01153321
D3320C00001
2010-020141-26 (EudraCT Number)

Details and patient eligibility

About

The purpose of the study is to find out if AZD2423 can reduce inflammation in the lungs of patients with mild COPD.

Enrollment

71 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 criteria

  • 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)

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

71 participants in 2 patient groups, including a placebo group

1
Experimental group
Description:
Oral treatment
Treatment:
Drug: AZD2423
2
Placebo Comparator group
Description:
Oral treatment
Treatment:
Drug: AZD2423 Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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