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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-07-31

Brief Summary

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

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease Lung Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Oral treatment

Group Type EXPERIMENTAL

AZD2423

Intervention Type DRUG

100mg Oral dose od

2

Oral treatment

Group Type PLACEBO_COMPARATOR

AZD2423 Placebo

Intervention Type DRUG

Oral dose od

Interventions

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AZD2423

100mg Oral dose od

Intervention Type DRUG

AZD2423 Placebo

Oral dose od

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No