A Two Week Study to Assess the Tolerability of AZD9668 in Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT ID: NCT00703391

Last Updated: 2012-01-26

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-09-30

Brief Summary

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The purpose of this study is to assess the tolerability (effect of drug on body) and pharmacokinetics (effect of body on drug) of AZD9668 in patients with mild to moderate COPD

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Active Treatment

Group Type EXPERIMENTAL

AZD9668

Intervention Type DRUG

30mg oral tablets twice daily (bid) for 14 days

2

Placebo Treatment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matched placebo to 30mg oral tablet twice daily (bid) for 14 days

Interventions

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AZD9668

30mg oral tablets twice daily (bid) for 14 days

Intervention Type DRUG

Placebo

Matched placebo to 30mg oral tablet twice daily (bid) for 14 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Mild to moderate COPD
* Smokers or ex-smokers
* post-menopausal females

Exclusion Criteria

* Past history or current evidence of clinically significant heart disease
* Lung disease other than COPD
* Treatment with systemic steroids within 8 weeks of study visit 2
* Treatment with antibiotics within 4 weeks of study visit 1 or study visit 2
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 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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Kristina Panke

Role: PRINCIPAL_INVESTIGATOR

Parexel International GmbhH (CRO)

Locations

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Research Site

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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D0520C00002

Identifier Type: -

Identifier Source: org_study_id

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