14729-D9831C00002- 1 Month Biopsy Study

NCT ID: NCT00766415

Last Updated: 2014-02-28

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

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-06-30

Brief Summary

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The purpose of this study is to study histological changes, cellularity, clinical efficacy and safety of AZD1981 in patients with Chronic Obstructive Pulmonary Disease

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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AZD1981

Group Type EXPERIMENTAL

AZD1981

Intervention Type DRUG

Oral tablet, twice daily, 4 weeks treatment

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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AZD1981

Oral tablet, twice daily, 4 weeks treatment

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men or women 40 years or above
* FEV1 between 40 and 80% of predicted normal value post-bronchodilator
* Clinical diagnosis of COPD

Exclusion Criteria

* Other clinically relevant disease or disorders
* Exacerbation of COPD within 30 days
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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Responsibility Role SPONSOR

Principal Investigators

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Norbert Krug

Role: PRINCIPAL_INVESTIGATOR

Fraunhofer Institute

Locations

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Research Site

Frieburg, , Germany

Site Status

Research Site

Großhansdorf, , Germany

Site Status

Research Site

Hanover, , Germany

Site Status

Research Site

Amsterdam, , Netherlands

Site Status

Research Site

Leicester, , United Kingdom

Site Status

Research Site

London, , United Kingdom

Site Status

Research Site

Manchester, , United Kingdom

Site Status

Research Site

Newcastle upon Tyne, , United Kingdom

Site Status

Countries

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Germany Netherlands United Kingdom

Other Identifiers

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D9831C00002

Identifier Type: -

Identifier Source: org_study_id

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