AZD2423 Safety and Tolerability Study in Patients With Moderate and Severe 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

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-03-31

Brief Summary

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

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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

TRIPLE

Participants Caregivers Investigators

Study Groups

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AZD2423

AZD2423 Oral Treatment for 28 days

Group Type EXPERIMENTAL

AZD2423

Intervention Type DRUG

100 mg oral treatment once daily for 28 days

Placebo

Oral treatment for 28 days

Group Type PLACEBO_COMPARATOR

Placebo to AZD2423

Intervention Type DRUG

Oral treatment once daily for 28 days

Interventions

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AZD2423

100 mg oral treatment once daily for 28 days

Intervention Type DRUG

Placebo to AZD2423

Oral treatment once daily for 28 days

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No