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A Study To Assess The Safety And Tolerability Of GW642444 In Subjects With Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT00372112

Last Updated: 2018-04-02

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

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-03

Study Completion Date

2007-05-10

Brief Summary

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The compound GW642444 has previously been found to be well tolerated with no significant side effects in subjects with asthma and healthy volunteers. This study will assess the safety and tolerability of GW642444 in subjects with COPD in order to obtain information to support dosing in a broader population of subjects with COPD

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Detailed Description

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A multicentre, randomised, placebo-controlled, double-blind, 4-arm parallel-group, 2-week study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of GW642444H (100 administered once daily in the morning via DISKUS™ dry-powder inhaler) compared with SEREVENT (salmeterol) (50mcg administered twice daily via DISKUS dry-powder inhaler) and placebo in subjects with moderate COPD.

Conditions

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Pulmonary Disease, Chronic Obstructive

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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100 mcg GW642444H

Twice daily in the morning.

Group Type ACTIVE_COMPARATOR

GW642444

Intervention Type DRUG

GW642444H

400 mcg GW642444H

Twice daily in the morning.

Group Type ACTIVE_COMPARATOR

GW642444

Intervention Type DRUG

GW642444H

50 mcg salmeterol

Twice daily.

Group Type ACTIVE_COMPARATOR

GW642444

Intervention Type DRUG

GW642444H

placebo

Twice daily

Group Type PLACEBO_COMPARATOR

GW642444

Intervention Type DRUG

GW642444H

Placebo

Intervention Type OTHER

Placebo administered twice daily

Interventions

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GW642444

GW642444H

Intervention Type DRUG

Placebo

Placebo administered twice daily

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* females must be of non-childbearing potential
* moderately severe COPD

Exclusion Criteria

* Subjects with a main diagnosis of asthma
* subjects with poorly controlled COPD
* subjects with significant heart, renal, endocrine, psychiatric, immunological or neurological disease.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Camperdown, New South Wales, Australia

Site Status

GSK Investigational Site

Nedlands, Western Australia, Australia

Site Status

GSK Investigational Site

Rousse, , Bulgaria

Site Status

GSK Investigational Site

Sofia, , Bulgaria

Site Status

GSK Investigational Site

Sofia, , Bulgaria

Site Status

GSK Investigational Site

Weinheim, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Hanover, Lower Saxony, Germany

Site Status

GSK Investigational Site

Geesthacht, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Breda, , Netherlands

Site Status

GSK Investigational Site

Hoorn, , Netherlands

Site Status

GSK Investigational Site

Auckland, , New Zealand

Site Status

GSK Investigational Site

Tauranga, , New Zealand

Site Status

GSK Investigational Site

Bucharest, , Romania

Site Status

GSK Investigational Site

Iași, , Romania

Site Status

Countries

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Australia Bulgaria Germany Netherlands New Zealand Romania

Study Documents

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Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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B2C108562

Identifier Type: -

Identifier Source: org_study_id

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