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

GlaxoSmithKline30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

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

Interventions

GW856553DRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (3)

GSK Investigational Site

Hanover, Lower Saxony, Germany

GSK Investigational Site

Großhansdorf, Schleswig-Holstein, Germany

GSK Investigational Site

Berlin, State of Berlin, Germany

Outcomes

Primary Outcomes

Measurements of adverse events, changes in heart rate, blood pressure, blood tests, heart function and lung function throughout the 14 day study. Exacerbations of COPD over the 14 day study.

Time frame: 14 days

Secondary Outcomes

Inhibition of inflammatory agents in the blood after 7 and 14 days of dosing.

Time frame: after 7 and 14 days of dosing

Concentration of the drug in the blood after 1, 3, 7, 10 and 14 days of dosing.

Time frame: after 1, 3, 7, 10 and 14 days of dosing

Data from ClinicalTrials.gov

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