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Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT00629239

Last Updated: 2010-12-06

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

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-08-31

Brief Summary

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The purpose of this study is to see if treatment with AZD4818 for four weeks is tolerable, safe and effective in treating COPD and, if so, how it compares with placebo.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Keywords

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COPD tolerability inhalation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

AZD4818

Group Type EXPERIMENTAL

AZD4818

Intervention Type DRUG

Dry Powder, inhalation, b.i.d., 4 weeks

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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AZD4818

Dry Powder, inhalation, b.i.d., 4 weeks

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of COPD, with symptoms for more than 1 year
* Current or ex-smokers with a smoking history of at least 10 pack-years (1 pack-year=20 cigarettes/day for 1 year)
* Lung function (FEV1) 40 to 80% of the predicted normal value after using a short acting bronchodilator

Exclusion Criteria

* Clinical suspicion of active tuberculosis
* Any current clinically significant respiratory tract disorder other than COPD
* History of current clinically relevant arrhythmia, heart block, ECG abnormalities, or unstable angina
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals

Principal Investigators

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Huib AM Kerstjens, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Centre, Groningen, The Netherlands

Locations

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Research Site

Hvidovre, , Denmark

Site Status

Research Site

København NV, , Denmark

Site Status

Research Site

Odense C, , Denmark

Site Status

Research Site

Helsinki, , Finland

Site Status

Research Site

Preitilä, , Finland

Site Status

Research Site

Tampere, , Finland

Site Status

Research Site

Breda, , Netherlands

Site Status

Research Site

Groningen, , Netherlands

Site Status

Research Site

Elverum, , Norway

Site Status

Research Site

Oslo, , Norway

Site Status

Research Site

Trondheim, , Norway

Site Status

Research Site

Lund, , Sweden

Site Status

Countries

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Denmark Finland Netherlands Norway Sweden

Other Identifiers

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D3540C00005

Identifier Type: -

Identifier Source: org_study_id