A 4 Week Study to Investigate the Safety and Tolerability of AZD5069 in Patients With Moderate to 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

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-03-31

Brief Summary

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The purpose of this study is the evaluate the safety and tolerability of AZD5069 in patients with Chronic Obstructive Pulmonary Disease

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Detailed Description

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Conditions

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Scientific Terminology Chronic Obstructive Pulmonary Disease (COPD) Laymen Terminology Chronic Bronchitis and Emphysema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Placebo dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral dose bid

2

Treatment arm AZD5069 50mg

Group Type EXPERIMENTAL

AZD5069 50mg

Intervention Type DRUG

Oral dose bid

3

Treatment arm AZD5069 80mg

Group Type EXPERIMENTAL

AZD5069 80mg

Intervention Type DRUG

Oral dose bid

Interventions

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Placebo

Oral dose bid

Intervention Type DRUG

AZD5069 50mg

Oral dose bid

Intervention Type DRUG

AZD5069 80mg

Oral dose bid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of COPD with symptoms for more than one year before screening
* Body mass index of 18-30 kg/m2 and weight of 50-100kg
* Current or ex-smokers with a smoking history of at least 10 pack years (1 pack year = tobacco consumption corresponding to 20 cigarettes smoked per day for one year) at screening
* FEV1 of 30% or above and less than 80% of the predicted normal value post-bronchodilator at screening
* FEV1/FVC less than 70% post-bronchodilator at screening

Exclusion Criteria

* Any clinically significant disease or disorder
* Exacerbation of COPD which was not resolved within 30 days of first dosing
* Patients who have received live or live-attenuated vaccine in the 2 weeks prior to first dosing
* Asthma and any current respiratory tract disorder other than COPD which is considered to be clinically significant
* Disease history suggesting reduced or abnormal immune function other than that related to COPD

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No