Safety/Tolerability Study With AZD1236 in Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT ID: NCT00758459

Last Updated: 2011-08-19

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

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-03-31

Brief Summary

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The primary aim of this study is to investigate the tolerability and safety of AZD 1236 compared with placebo ("inactive substance") in COPD patients by assessment of Adverse Events, vital signs and laboratory safety assessments.

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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1

Group Type EXPERIMENTAL

AZD1236

Intervention Type DRUG

oral tablet, 75 mg, twice daily during 6 weeks

2

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 reduced lung function
* 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
* Use of oral or parenteral glucocorticosteroids within 30 days prior to the study
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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Helgo Magnussen, MD, Professor

Role: PRINCIPAL_INVESTIGATOR

Pulmonary research institute at Hospital Grosshansdorf, Wöhrendamm, Grosshansdorf Germany

Andrew Lockton, MD

Role: STUDY_DIRECTOR

AstraZeneca R&D Charnwood

Locations

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Research Site

Rousse, , Bulgaria

Site Status

Research Site

Sofia, , Bulgaria

Site Status

Research Site

Helsinki, , Finland

Site Status

Research Site

Oulu, , Finland

Site Status

Research Site

Preitilä, , Finland

Site Status

Research Site

Berlin, , Germany

Site Status

Research Site

Grobhansdorf, , Germany

Site Status

Research Site

Győr, , Hungary

Site Status

Research Site

Komló, , Hungary

Site Status

Research Site

Pécs, , Hungary

Site Status

Research Site

Vásárosnamény, , Hungary

Site Status

Research Site

Bojnice, , Slovakia

Site Status

Research Site

Liptovský Hrádok, , Slovakia

Site Status

Research Site

Žilina, , Slovakia

Site Status

Countries

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Bulgaria Finland Germany Hungary Slovakia

Other Identifiers

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D4260C00003

Identifier Type: -

Identifier Source: org_study_id

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