A Study To Investigate The Effects Of GW856553 On Patients With COPD (Chronic Obstructive Pulmonary Disease)

NCT ID: NCT00392587

Last Updated: 2012-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Brief Summary

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The purpose of this study is to assess the safety of GW856553 in COPD patients and to assess its affects on their COPD disease after 14 days.

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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GW856553

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women of childbearing potential
* Established history of COPD
* Cigarette smoking history greater than 10 pack years
* FEV1 between 40 and 80% of predicted normal for height, age and sex.

Exclusion Criteria

* Morbidly obese patients (body mass index \>40)
* Hospitalisation or treatment for worsening of COPD in past 6 weeks
* History of increased liver function tests
* hypersensitivity to salbutamol or ipratropium bromide
* Blood pressure \> 155/95
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 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

Hanover, Lower Saxony, Germany

Site Status

GSK Investigational Site

Großhansdorf, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

References

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Yang S, Lukey P, Beerahee M, Hoke F. Population pharmacokinetics of losmapimod in healthy subjects and patients with rheumatoid arthritis and chronic obstructive pulmonary diseases. Clin Pharmacokinet. 2013 Mar;52(3):187-98. doi: 10.1007/s40262-012-0025-6.

Reference Type DERIVED
PMID: 23254770 (View on PubMed)

Other Identifiers

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MKI106209

Identifier Type: -

Identifier Source: org_study_id

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