A Phase IIa Study Assessing the Effects of AZD1236 on Biomarkers in Chronic Obstructive Pulmonary Disease (COPD) Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-05-31

Brief Summary

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The primary aim of this study is to investigate the effects of AZD1236 compared with placebo ("inactive substance") in COPD patients by analysing biomarkers for inflammation and tissue degradation in blood, urine and sputum.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AZD1236

oral tablet, 75 mg, twice daily during 6 weeks

Group Type EXPERIMENTAL

AZD1236

Intervention Type DRUG

oral tablet, 75 mg, twice daily during 6 weeks

Placebo

Dosing to match AZD1236

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Dosing to match AZD1236

Interventions

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AZD1236

oral tablet, 75 mg, twice daily during 6 weeks

Intervention Type DRUG

Placebo

Dosing to match AZD1236

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of COPD for 1 month
* Men or postmenopausal women
* Spirometry values indicating symptomatic patients
* Smoking history equivalent to using 20 cigarettes a day for 10 years.

Exclusion Criteria

* Any current respiratory tract disorders other than COPD
* Requirement for regular oxygen therapy
* Acute worsening of COPD (exacerbation) 1,5 month prior to study drug administration
* Use of oral or parenteral glucocorticosteroids within 30 days and use of inhaled steroids 14 days prior to the study

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No